ev3 Inc. 2022-01-26 Health critical FDA
Health · FDA · Recall #FDA-Z-0450-2022
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT.,… Recall
Issued January 26, 2022 · ev3 Inc.
In January 2022, ev3 Inc. recalled the Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT.,…, 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
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
What you should do
- 1 Stop using Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT.,… 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
- January 26, 2022
- Units affected
- Not reported
- Sold at
- Worldwide Distribution: US (nationwide), including PR; and Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, B
- Recall number
- FDA-Z-0450-2022
- 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.