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Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containin...

FDA Device Recall #Z-0625-2022 — Class I — January 11, 2022

Recall Summary

Recall Number Z-0625-2022
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 1265 units

Product Description

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-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: 13F19M0129 / (01)10801902121315 (17)211130 (10)13F19M0129, Components: Code PT-65709-C, Lot number 13C19M0499; Lot Number / UDI: 13F20B0053 / (01)108019022121315 (17)220131 (10)13F20B0053, Components: Code PT-65709-C, Lot number 13C20A0970; Lot Number / UDI: 13F20C0595 / (01)10801902121315 (17)220331 (10)13F20C0595, Components: Code PT-65709-C, Lot number 13C20C2089; Code PT-65709-C, Lot number 13C20C2082; Lot Number / UDI: 13F20F0231 / (01)10801902121315 (17)220531 (10)13F20F0231, Components: Code PT-65709-C, Lot number 13C20F1139; Lot Number / UDI: 13F20G0361 / (01)10801902121315 (17)220731 (10)13F20G0361, Components: Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-C, Lot number 13C20G0228; Lot Number / UDI: 13F20K0632 / (01)10801902121315 (17)221031 (10)13F20K0632, Components: Code PT-65709-C, Lot number 13C20H1675; Lot Number / UDI: 13F21A0353 / (01)10801902121315 (17)221231 (10)13F21A0353, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-C, Lot number 13C20J2689; Lot Number / UDI: 13F21C0748 / (01)10801902121315 (17)230331 (10)13F21C0748, Components: Code PT-65709-C, Lot number 13C21C1696; Lot Number / UDI: 13F21D0721 / (01)10801902121315 (17)230430 (10)13F21D0721, Components: Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-C, Lot number 13C21C0326; Lot Number / UDI: 13F21E0823 / (01)10801902121315 (17)230531 (10)13F21E0823, Components: Code PT-65709-C, Lot number 13C21E0328; Lot Number / UDI: 13F21F1189 / (01)10801902121315 (17)230630 (01)13F21F1189, Components: Code PT-65709-C, Lot number 13C21E1991; Code PT-65709-C, Lot number 13C21E0328

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-0629-2022 Class I Arrow-Trerotola PTD Set (Percutaneous Thromboly... Jan 11, 2022
Z-0628-2022 Class I 5 Fr. X 65 cm Arrow-Trerotola 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.

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