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U.S. Department of Health and Human Services

Class 2 Device Recall Automated Impella Controller (AIC)

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 Class 2 Device Recall Automated Impella Controller (AIC)see related information
Date Initiated by FirmMarch 01, 2021
Date PostedFebruary 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1175-2024
Recall Event ID 93876
PMA NumberP140003 
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
ProductAutomated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Code Information 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
Recalling Firm/
Manufacturer		 Abiomed, Inc.
24 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information ContactClinical Support Center
800-422-8666
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionThis 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.
Quantity in Commerce4,463 (US)
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OZD
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