[Recalled] Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. — The device has similarities in design to another device that the firm recently… | FDA 2022-02-0
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. |
|---|---|
| Brand / manufacturer | ev3 Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0695-2022 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 04 February 2022 |
| EAN / barcode | 00763000402419 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.