Abiomed, Inc.: Temporary Non-roller Type Left Heart Support Blood Pump
- Recalling firm
- Abiomed, Inc.
- Product
- Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP...
- Reason
- Increased risk of purge leaks with Generation 1 purge cassettes.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-18
- Status
- Open, Classified
- Distribution
- Worldwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/075d29ff-b534-439a-b16e-5480d3980e34