FDA Device recall Z-0231-2022
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Th…
- 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-12709-WC The Arrow-Trerotola" Percutaneous Th… 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-0231-2022 |
| 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-12709-WC 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: 13F19K0564 13F20C0094 13F20G0284 13F20L0282 13F21A0497 13F21A0718 13X21E0008 13F21F1187 |
|---|
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-0231-2022%22
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