Recall archive / FDA device enforcement
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65... — FDA record Z-0626-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS 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
- The firm received reports indicating PTD tip separation during use.
- Classification
- Class I
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 1874 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0626-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Number / UDI: 13F20C0596 / (01)10801902121308 (17)220331 (10)13F20C0596, Components: Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20B1435; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C20C1558; Lot Number / UDI: 13F20F0081 / (01)10801902121308 (17)220531 (10)13F20F0081, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C20C1558; Lot Number / UDI: 13F20F0229 / (01)10801902121308 (17)220531 (10)13F20F0229, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F0570; Code PT-03009, Lot number 13C20C1558; Lot Number / UDI: 13F20F0509 / (01)10801902121308 (17)220531 (10)13F20F0509, Components: Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20F0578 / (01)10801902121308 (17)220630 (10)13F20F0578, Components: Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HS, Lot number 14C20D1061; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20F1138; Lot Number / UDI: 13F20G0177 / (01)10801902121308 (17)220630 (10)13F20G0177, Components: Code PT-65709-C, Lot number 13C20G0228; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20G0238 Lot Number / UDI: 13F20G0566 / (01)10801902121308 (17)220630 (10)13F20G0566, Components: Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0864; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585; Lot Number / UDI: 13F20H0531 / (01)10801902121308 (17)220831 (10)13F20H0531, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20G0395; Code PT-03009, Lot number 13C20G1198; Code PT-03009, Lot number 13C20G0864; Lot Number / UDI: 13F20J0379 / (01)10801902121308 (17)220831 (10)13F20J0379, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20H0604; Lot Number / UDI: 13F20L0514 / (01)10801902121308 (17)221031 (10)13F20L0514, Components: Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HS, Lot number 14C20H0384; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20L0871; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI: 13F21A0354 / (01)10801902121308 (17)221231 (10)13F21A0354, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13F21C0081 / (01)10801902121308 (17)230228 (10)13F21C0081, Components: Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21B1533; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21C0749 / (01)10801902121308 (17)230331 (10)13F21C0749, Components: Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 13C21C1696; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21D0870 / (01)10801902121308 (17)230430 (10)13F21D0870, Components: Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21C0327; Lot Number / UDI: 13F21E0415 / (01)10801902121308 (17)230430 (10)13F21E0415, Components: Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21C0476; Code PT-65709-HS, Lot number 14C21B0690; Code PT-03009, Lot number 13C21C2397; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21F1188 / (01)10801902121308 (17)230630 (10)13F21F1188, Components: Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21E1991; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21E0722 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 23, 2022
- Recall initiation date
- Jan 11, 2022
- Center classification date
- Feb 15, 2022
- Termination date
- Sep 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.