ev3 Inc. 2022-03-16 Health critical FDA
Health · FDA · Recall #FDA-Z-0695-2022
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number… Recall
Issued March 16, 2022 · ev3 Inc.
In March 2022, ev3 Inc. recalled the Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ev3 Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ev3 Inc.
- Category
- Health
- Recall date
- March 16, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
- Recall number
- FDA-Z-0695-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- ev3 Inc. has 2 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.