Abiomed, Inc. 2026-07-22 Health critical FDA
Health · FDA · Recall #FDA-Z-2682-2026
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14… Recall
Issued July 22, 2026 · Abiomed, Inc.
In July 2026, Abiomed, Inc. recalled the ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14…, 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
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
What you should do
- 1 Stop using ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14… 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
- July 22, 2026
- Units affected
- Not reported
- Sold at
- Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croat
- Recall number
- FDA-Z-2682-2026
- 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.