Abiomed, Inc. 2026-03-11 Health critical FDA
Health · FDA · Recall #FDA-Z-1470-2026
Impella RP Flex with SmartAssist. Product Code: 1000323. Recall
Issued March 11, 2026 · Abiomed, Inc.
In March 2026, Abiomed, Inc. recalled the Impella RP Flex with SmartAssist. Product Code: 1000323., 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
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
What you should do
- 1 Stop using Impella RP Flex with SmartAssist. Product Code: 1000323. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abiomed, 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
- Abiomed, Inc.
- Category
- Health
- Recall date
- March 11, 2026
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, S
- Recall number
- FDA-Z-1470-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Abiomed, Inc. has 9 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.