Device product
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Z-0441-2024
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 93406
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0441-2024
Official wording
Reason: Pump not detected as connected to controller due to software issue.
Code information: UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617.
Distribution pattern: US: AZ, CA, FL, NY & VA.
Derived failure modes
-
Device software or design
software issue