Recall Z-0695-2022— ev3 Inc.
Class I · Terminated
Class I FDA medical device recall by ev3 Inc., initiated 2022-02-04, terminated 2024-10-02. It names one FDA 510(k) clearance: K212027. Product: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. 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..
- Recalling firm
- ev3 Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-02-04
- Terminated
- 2024-10-02
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.