Abiomed, Inc.: Introducer, Catheter
Recall Summary Abiomed is recalling Insertion Kits containing 14Fr and 23Fr Introducer sheaths used with heart pump systems due to potential leakage from under the sheath cap and along hub seams. These manufacturing defects cannot be seen by users but are present in every pump set distributed worldwide. This is a Class II recall affecting hospitals and medical facilities across the US, Canada, Australia, and numerous other countries.
- Recalling firm
- Abiomed, Inc.
- Product
- ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. 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/a1e72fe9-7c9a-4c62-92b5-179b1b5409d0