FDA-Device2024-02-28Class II
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Abiomed, Inc.
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.
Sold states
US Nationwide distribution.
Affected count
4,463 (US)
Manufactured in
24 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2024Don't want to check this manually?
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