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U.S. Department of Health and Human Services

Class 2 Device Recall Abiomed

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 Class 2 Recall
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Date Posted March 07, 2007
Recall Status1 Terminated on February 07, 2008
Recall Number Z-0574-2007
Recall Event ID 37170
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product AB5000 Console Circulatory Support System Catalog Number: 0015-0000
Code Information Serial Numbers: 5261- 5317
Recalling Firm/
Abiomed, Inc.
22 Cherry Hill Dr
Danvers, Massachusetts 01923-2575
For Additional Information Contact William Bolt
Manufacturer Reason
for Recall
Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Manufacturing Material Removal
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.