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Class 2 Device Recall Automated Impella Controller (AIC) |
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Date Initiated by Firm |
October 10, 2023 |
Date Posted |
December 01, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0441-2024 |
Recall Event ID |
93406 |
PMA Number |
P140003 |
Product Classification |
Temporary non-roller type left heart support blood pump - Product Code OZD
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Product |
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. |
Code Information |
UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617. |
Recalling Firm/ Manufacturer |
Abiomed, Inc. 24 Cherry Hill Dr Danvers MA 01923-2575
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For Additional Information Contact |
978-646-1400
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Manufacturer Reason for Recall |
Pump not detected as connected to controller due to software issue.
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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
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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.
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PMA Database |
PMAs with Product Code = OZD and Original Applicant = ABIOMED, INC.
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