Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, contain...
FDA Device Recall #Z-0623-2022 — Class I — January 11, 2022
Recall Summary
| Recall Number | Z-0623-2022 |
| 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 | 676 units |
Product Description
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, 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: 13F19K0564 / (01)20801902156758 (17)210930 (10)13F19K0564, Components: Code PT-12709-CA, Lot number 13C19K2024; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094, Components: Code PT-12709-C, Lot number 13C20C0498; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284, Components: Code PT-12709-C, Lot number 13C20G0230; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585; Lot Number / UDI: 13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI 13F21A0497 / (01)10801902121254 (17)221231 (10)13F21A0497, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13F21A0718 / (01)10801902121254 (17)230131 (10)13F21A0718, Components: Code PT-12709-C, Lot number 13C21A1963; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21A0855; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13X21E0008 / (01)10801902121254 (17)230630 (10)13F21F1187, Components: Code PT-12709-C, Lot number 13C21C1690; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Lot Number / UDI: 13F21F1187 / (01)10801902121254 (17)230531 (10)13X21E0008, Components: Code PT-12709-C, Lot number 13X21E0009; Code PT-65709-HS, Lot number 14X21D0002; Code PT-03009, Lot number 13X21E0007
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-0624-2022 | 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.