Abiomed, Inc.: Introducer, Catheter
Abiomed is recalling Impella CP heart pump sets worldwide due to potential leakage in the introducer sheaths (medical tubes used during implantation). The leakage can occur under the sheath cap and along seam lines in 14Fr and 23Fr sizes, but cannot be seen by users. The recall affects pump sets distributed across the US, Canada, Australia, and numerous other countries.
- Recalling firm
- Abiomed, Inc.
- Product
- ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-11
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT),...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6786b8b1-c6bc-422e-b488-65bc3576fbd5