ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, ...
FDA Device Recall #Z-0268-2014 — Class I — October 21, 2013
Recall Summary
| Recall Number | Z-0268-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | October 21, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Vascular |
| Location | Danvers, MA |
| Product Type | Devices |
| Quantity | 5 |
Product Description
ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Reason for Recall
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Distribution Pattern
Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
Lot / Code Information
G13A00118 G13A00715 G13A00716 G13A00843 G13A00937 G13A01601 G13A01620 G13A01621 G13A01638 G13A01639 G13A01650 GV854 GW761
Other Recalls from Medtronic Vascular
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1860-2021 | Class I | Angiographic Guidewire Component: Model Number:... | May 4, 2021 |
| Z-1245-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cmJL 3... | Jan 15, 2021 |
| Z-1247-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100cm EBU ... | Jan 15, 2021 |
| Z-1246-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm JR... | Jan 15, 2021 |
| Z-1248-2021 | Class II | Medtronic 6F Launcher Guide Catheter 100 cm EBU... | Jan 15, 2021 |
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.