Recall archive / FDA device enforcement
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-6570... — FDA record Z-0625-2022
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-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
- The firm received reports indicating PTD tip separation during use.
- Classification
- Class I
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 1265 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0625-2022
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: 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 |
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.