Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151...
FDA Device Recall #Z-0680-2025 — Class II — November 25, 2024
Recall Summary
| Recall Number | Z-0680-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Spectranetics Corporation |
| Location | Colorado Springs, CO |
| Product Type | Devices |
| Quantity | 40,276 catheters |
Product Description
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
Reason for Recall
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Distribution Pattern
U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, ILIN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Australia, Belgium, Brazil, China, Croatia, Cyprus, Czech Republic, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Poland, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Lot / Code Information
Model Number / 12NC / Product Description 414-151 / 989930000531 / 1.4 mm OTW Lot Numbers / UDI codes: FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A 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(01)00813132024710(17)250320(10)FAY23C09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24E30A (01)00813132024710(17)260618(10)FAY24E30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24G17A (01)00813132024710(17)260805(10)FAY24G17A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY23C09A (01)00813132024710(17)250320(10)FAY23C09A FAY23A31A (01)00813132024710(17)250213(10)FAY23A31A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23A17A (01)00813132024710(17)250127(10)FAY23A17A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY23M06A (01)00813132024710(17)251211(10)FAY23M06A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23G13A (01)00813132024710(17)250802(10)FAY23G13A FAY23F13A (01)00813132024710(17)250627(10)FAY23F13A FAY23D21A (01)00813132024710(17)250427(10)FAY23D21A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B16A (01)00813132024710(17)260227(10)FAY24B16A FAY24D09A (01)00813132024710(17)260424(10)FAY24D09A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY23H31A (01)00813132024710(17)250912(10)FAY23H31A FAY23H02A (01)00813132024710(17)250814(10)FAY23H02A FAY23D26A (01)00813132024710(17)250501(10)FAY23D26A FAY23A04A (01)00813132024710(17)250109(10)FAY23A04A FAY23C30A (01)00813132024710(17)250412(10)FAY23C30A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24B26A (01)00813132024710(17)260312(10)FAY24B26A FAY24F24A (01)00813132024710(17)260712(10)FAY24F24A FAY24F25A (01)00813132024710(17)260716(10)FAY24F25A FAY24H02A (01)00813132024710(17)260819(10)FAY24H02A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24B09A (01)00813132024710(17)260215(10)FAY24B09A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY24A22A (01)00813132024710(17)260207(10)FAY24A22A FAY23J05A (01)00813132024710(17)251020(10)FAY23J05A FAY23J25A (01)00813132024710(17)250927(10)FAY23J25A FAY23H08A (01)00813132024710(17)250821(10)FAY23H08A FAY23H02A (01)00813132024710(17)250814(10)FAY23H0
Other Recalls from Spectranetics Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1070-2025 | Class I | Intact Vascular Tack Endovascular System, to tr... | Jan 10, 2025 |
| Z-0509-2024 | Class II | Spectranetics Turbo-Elite Laser Atherectomy Cat... | Nov 15, 2023 |
| Z-0221-2023 | Class II | Philips Laser System, REF: LAS-100. Used in mi... | Oct 14, 2022 |
| Z-1351-2022 | Class II | Philips Laser System, REF LAS-100, Intermittent... | Jun 1, 2022 |
| Z-2143-2020 | Class II | Bridge Occlusion Balloon, REF 590-001, QTY 1, S... | Mar 31, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.