Arrow-Trerotola PTD Set — Class I medical device recall Z-0629-2022
Terminated recall by TELEFLEX MEDICAL INC, reported 2022-02-23, distributed nationwide. The firm received reports indicating PTD tip separation during use.
| Recall number | Z-0629-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX MEDICAL INC, Morrisville, NC, United States |
| Recall initiated | 2022-01-11 |
| Classified | 2022-02-15 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2024-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 14,583 units |
| UPC / GTIN / UDI-DI | 00801902013156, 10801902013153, 10801902194074, 20801902194071 |
| Model numbers | PT-65509 |
Product
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0629-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.