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U.S. Department of Health and Human Services

Class 2 Device Recall Abiomed

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  Class 2 Device Recall Abiomed see related information
Date Initiated by Firm January 08, 2007
Date Posted March 07, 2007
Recall Status1 Terminated 3 on February 07, 2008
Recall Number Z-0574-2007
Recall Event ID 37170
Product Classification Circulatory Support System - Product Code DSQ
Product AB5000 Console Circulatory Support System
Catalog Number: 0015-0000
Code Information Serial Numbers: 5261- 5317
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information Contact William Bolt
978-777-5410
Manufacturer Reason
for Recall		 Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
FDA Determined
Cause 2		 Other
Action Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Quantity in Commerce 55 units
Distribution Worldwide, including USA, Japan, Germany, Australia, and Mexico.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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