Abiomed, Inc.: Temporary Non-roller Type Left Heart Support Blood Pump
Recall Summary Abiomed is recalling certain Impella CP Set with SmartAssist left heart support blood pumps due to a potential issue where low purge pressure may cause persistent alarms or loss of mechanical support. The affected products were distributed in seven U.S. states (Georgia, Iowa, Nebraska, Pennsylvania, Texas, Washington, and Wisconsin) and internationally to the Czech Republic, Norway, and Japan.
- Recalling firm
- Abiomed, Inc.
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Reason
- Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-18
- Status
- Open, Classified
- Areas affected
- GA, IA, NE, PA, TX, WA, WI
- Distribution
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e0e89a34-ac35-426c-a89c-2b09808e17fc