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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 Firm October 10, 2023
Date Posted December 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-0440-2024
Recall Event ID 93406
PMA Number P140003 
Product Classification Temporary non-roller type left heart support blood pump - Product Code OZD
Product Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Code Information UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404.
Recalling Firm/
Manufacturer		 Abiomed, Inc.
24 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information Contact
978-646-1400
Manufacturer Reason
for Recall		 Pump not detected as connected to controller due to software issue.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Correction was issued vail mail October 24. 2023. Customers are advised to examine inventory for product running AIC software version: V8.4 or V8.4.1. Do not to use the product unless software is updated. Contact adminsfs@abiomed.com to schedule the software update and return the business reply form. Forward this information to relevant personnel and any facility product may have been transferred to.
Distribution US: AZ, CA, FL, NY & VA.
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = OZD and Original Applicant = ABIOMED, INC.
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