Recall Z-0440-2024— Abiomed, Inc.
Class II · Terminated
Class II FDA medical device recall by Abiomed, Inc., initiated 2023-10-10, terminated 2025-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.. Reason: Pump not detected as connected to controller due to software issue..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2023-10-10
- Terminated
- 2025-03-06
- Firm location
- Danvers, MA, United States
Product description
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Reason for recall
Pump not detected as connected to controller due to software issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.