Medtronic TurboHawk Plus Directional Atherectomy System 6F — Class I medical device recall Z-0694-2022
Terminated recall by ev3 Inc., reported 2022-03-16, distributed nationwide. The device has similarities in design to another device that the firm recently issued a field correction on du
| Recall number | Z-0694-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ev3 Inc., Plymouth, MN, United States |
| Recall initiated | 2022-02-04 |
| Classified | 2022-03-07 |
| Reported by FDA | 2022-03-16 |
| Terminated | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 441 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00763000402396 |
Product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Reason for recall
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
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-0694-2022. 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.