FDA Device recall Z-0694-2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature
- FDA Device
- Class I
- terminated
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class I recall of Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature by Ev3, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0694-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-02-04 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ev3 |
| Distribution | US |
Product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Reason
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.
Identifiers
| code_info | GTIN 00763000402396 |
|---|
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-0694-2022%22
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