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Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-4...

FDA Device Recall #Z-0627-2022 — Class I — January 11, 2022

Recall Summary

Recall Number Z-0627-2022
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 3668 units

Product Description

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T 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: 13F20A0209 / (01)10801902121261(17)211231(10)13F20A0209, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0054 / (01)10801902121261(17)220131(10)13F20B0054, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C20A1583; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0527 / (01)10801902121261(17)220228(10)13F20B0527, Components: Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-S6, Lot number 14C20A0602; Lot Number / UDI: 13F20C0427 / (01)10801902121261(17)220228(10)13F20C0427, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20C0842; Lot Number / UDI: 13F20D0127 / (01)10801902121261(17)220331(10)13F20D0127, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-T, Lot number 13C20D0847; Lot Number / UDI: 13F20D0402 / (01)10801902121261(17)220430(10)13F20D0402, Components: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20D2088; Lot Number / UDI: 13F20F0390 / (01)10801902121261(17)220531(10)13F20F0390, Components: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20E0902; Lot Number / UDI: 13F20G0285 / (01)10801902121261(17)220630(10)13F20G0285, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number PT-45509-T; Code 13C20G0868, Lot Number / UDI: 13F20J0545 / (01)10801902121261(17)220831(10)13F20J0545, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20G1979; Lot Number / UDI: 13F20J0933 / (01)10801902121261(17)220930(10)13F20J0933, Components: Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577; Lot Number / UDI: 13F20K0851 / (01)10801902121261(17)221031(10)13F20K0851, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577; Lot Number / UDI: 13F20M0174 / (01)10801902121261(17)221120(10)13F20M0174, Components: Code PT-45509-S6, Lot number 14C20K1177; Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807; Lot Number / UDI: 13F21A0662 / (01)10801902121261(17)230131(10)13F21A0662, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807; Lot Number / UDI: 13F21C0079 / (01)10801902121261(17)230228(10)13F21C0079, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20J0354; Lot Number / UDI: 13F21C0751 / (01)10801902121261(17)230331(10)13F21C0751, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-T, Lot number 13C21C1697; Code PT-45509-T, Lot number 13C21B0771; Lot Number / UDI: 13X21D0027 / (01)10801902121261(17)230430(10)13X21D0027, Components: Code PT-45509-S6, Lot number 14X21D0003; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-T, Lot number 13X21D0009; Lot Number / UDI: 13F21F0399 / (01)10801902121261(17)230531(10)13F21F0399, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21D0675; Code PT-45509-T, Lot number 13C21E0717; Lot Number / UDI: 13F21G0226 / (01)10801902121261(17)230630(10)13F21G0226, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205; Lot Number / UDI: 13F21G1343 / (01)10801902121261(17)230731(10)13F21G1343, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205; Lot Number / UDI: 13F21H0639 / (01)10801902121261(17)230731(10)13F21H0639, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-S6, Lot number 14C21G1307; Code PT-45509-T, Lot number 13C21H0942; Lot Number / UDI: 13F21H1272 / (01)10801902194067(17)230831(10)13F21H1272, Components: Code PT-45509-T2, Lot number 13C21H2037; Code PT-45509-S7, Lot number 14C21H0978; Lot Number / UDI: 13F21L0900 / (01)10801902194067(17)231130(10)13f21l0900, Components: Code PT-45509-T2, Lot number 13C21L1103; Code PT-45509-S7, Lot number 14C21H1310

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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.

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