Abiomed, Inc.: Introducer, Catheter
Recall Summary Abiomed is recalling certain Impella CP heart pump sets worldwide due to a manufacturing defect in the introducers (medical tubes) that could cause fluid leakage under the sheath cap and at hub connection points. The leakage cannot be seen by users and affects 14Fr and 23Fr introducers, which are included in every pump set. This is a Class II recall affecting patients in the US and dozens of other countries.
- Recalling firm
- Abiomed, Inc.
- Product
- ABIOMED Impella CP Set, Pump Set Code 0048-0014; 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/6dcd3bcb-b45e-4539-ba25-463af8f3e954