Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) ...
FDA Device Recall #Z-0629-2022 — Class I — January 11, 2022
Recall Summary
| Recall Number | Z-0629-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | January 11, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TELEFLEX MEDICAL INC |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 14583 units |
Product Description
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
Reason for Recall
The firm received reports indicating PTD tip separation during use.
Distribution Pattern
Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.
Lot / Code Information
Lot Number / UDI: 13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286; Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426; Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640; Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141; Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276; Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353; Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424; Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352; Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425; Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426; Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122; Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123; Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124; Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403; Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204; Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232; Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389; Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353; Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729; Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378; Lot Number / UDI: 13F20J0546 / (01)00801902013156(17)220831(10)13F20J0546; Lot Number / UDI: 13F20J0771 / (01)00801902013156(17)220831(10)13F20J0771; Lot Number / UDI: 13F20K0503 / (01)00801902013156(17)220930(10)13F20K0503; Lot Number / UDI: 13F20K0504 / (01)00801902013156(17)220930(10)13F20K0504; Lot Number / UDI: 13F20K0630 / (01)00801902013156(17)220930(10)13F20K0630; Lot Number / UDI: 13F20K0631 / (01)00801902013156(17)220930(10)13F20K0631; Lot Number / UDI: 13F20M0175 / (01)00801902013156(17)221130(10)13F20M0175; Lot Number / UDI: 13F20M0176 / (01)00801902013156(17)221130(10)13F20M0176; Lot Number / UDI: 13F20M0177 / (01)00801902013156(17)221130(10)13F20M0177; Lot Number / UDI: 13F20M0178 / (01)10801902013153(17)221130(10)13F20M0178; Lot Number / UDI: 13F20M0181 / (01)00801902013156(17)221231(10)13F20M0181; Lot Number / UDI: 13F21A0352 / (01)00801902013156(17)221231(10)13F21A0352; Lot Number / UDI: 13F21B0159 / (01)00801902013156(17)230131(10)13F21B0159; Lot Number / UDI: 13F21B0222 / (01)00801902013156(17)230131(10)13F21B0222; Lot Number / UDI: 13F21B0519 / (01)10801902013153(17)230228(10)13F21B0519; Lot Number / UDI: 13F21C0364 / (01)00801902013156(17)230228(10)13F21C0364; Lot Number / UDI: 13F21C0365 / (01)00801902013156(17)230228(10)13F21C0365; Lot Number / UDI: 13F21D0462 / (01)00801902013156(17)230331(10)13F21D0462; Lot Number / UDI: 13F21E0079 / (01)00801902013156(17)230430(10)13F21E0079; Lot Number / UDI: 13F21E0259 / (01)00801902013156(17)230430(10)13F21E0259; Lot Number / UDI: 13F21E0260 / (01)00801902013156(17)230430(10)13F21E0260; Lot Number / UDI: 13F21E0556 / (01)00801902013156(17)230430(10)13F21E0556; Lot Number / UDI: 13F21F0641 / (01)00801902013156(17)230531(10)13F21F0641; Lot Number / UDI: 13F21G0227 / (01)00801902013156(17)230630(10)13F21G0227; Lot Number / UDI: 13F21G0401 / (01)00801902013156(17)230630(10)13F21G0401; Lot Number / UDI: 13F21G0772 / (01)00801902013156(17)230630(10)13F21G0772; Lot Number / UDI: 13F21H0447 / (01)10801902194074(17)230731(10)13F21H0447; Lot Number / UDI: 13F21K0827 / (01)10801902194074(17)231031(10)13F21K0827; Lot Number / UDI: 13F21K0898 / (01)10801902194074(17)231031(10)13F21K0898; Lot Number / UDI: 13F21L0227 / (01)20801902194071(17)231031(10)13F21L0227; Lot Number / UDI: 13F21L0507 / (01)10801902194074(17)231031(10)13F21L0507; Lot Number / UDI: 13F21L0898 / (01)10801902194074(17)231031(10)13F21L0898
Other Recalls from TELEFLEX MEDICAL INC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1126-2022 | Class II | (1) Gibeck Humid-Vent 2S Flex DC, Product #1773... | Apr 11, 2022 |
| Z-1127-2022 | Class II | (1) Teleflex Flex tube, Product #20011, sterile... | Apr 11, 2022 |
| Z-0628-2022 | Class I | 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0625-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
| Z-0623-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... | Jan 11, 2022 |
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.