Early Alert: Heart Pump Purge Cassette Issue From Abiomed
Summary Abiomed is issuing an early alert for Impella Generation 1 Purge Cassettes due to an increased risk of leaks in the purge system. These leaks can cause the heart pump to lose pressure and stop working. The alert affects users of this heart pump device.
- Recalling firm
- Early Alert
- Product
- Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops
- Reason
- Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-02-25
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/9519ac1d-6fb7-4582-99a3-3ce94017e926