FDA Device recall Z-0232-2022
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous…
- FDA Device
- Class I
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class I recall of Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous… by Arrow International, citing 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0232-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-09-20 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts
Reason
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
Identifiers
| code_info | Lot Number: 13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230 13F20F0577 13F20H0756 13F20K0849 13F20L02…Lot Number: 13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230 13F20F0577 13F20H0756 13F20K0849 13F20L0283 13F20M0182 13F21A0498 13F21B0158 13F21C0747 13F21E0555 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0232-2022%22
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