Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Hazard
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
What You Should Do
Remedy
This is a retrospective report for the March 2021 Technical Bulletin, which described a Product Update; specifically the AIC Version 8.5 Software Update. The software update began rollout on March 4, 2021. According to the firm, Version 8.5 of the software contained bug fixes for the issues seen in version 8.4. The technical bulletin was posted to HeartRecovery.com on March 5, 2021.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
- Brand
- Abiomed, Inc.
- UPC
- Product Code 0042-0000-US UDI-DI 00813502010022; Product Code 0042-0010-US UDI-DI 00813502010985; Product Code 0042-0040-US UDI-DI 00813502011401; Software Versions V8.4 and V8.4.1
Units Affected
4,463 (US)