Abiomed, Inc. 2026-06-24 Health critical FDA
Health · FDA · Recall #FDA-Z-2457-2026
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. Recall
Issued June 24, 2026 · Abiomed, Inc.
In June 2026, Abiomed, Inc. recalled the Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP., 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 Dana Whitfield, RecallCheckr
What this means for you
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
What you should do
- 1 Stop using Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. 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
- June 24, 2026
- Units affected
- Not reported
- Sold at
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- Recall number
- FDA-Z-2457-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Abiomed, Inc. has 11 recalls in our database, including 6 rated Critical.
- We're tracking 3,673 Health recalls in our database.
- This is the 453rd Health recall we've logged in 2026.