FDA Device recall Z-0233-2022
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thr…
- 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-W The Arrow-Trerotola" Percutaneous Thr… 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-0233-2022 |
| 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-W 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: 13F19M0129 13F20B0053 13F20C0595 13F20F0231 13F20G0361 13F20K0632 13F21A0353 13F21C0748 13F21D0721 13F21E0823 13F21F1189 |
|---|
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-0233-2022%22
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