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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 Abiomedsee related information
Date Initiated by FirmJanuary 08, 2007
Date PostedMarch 07, 2007
Recall Status1 Terminated 3 on February 07, 2008
Recall NumberZ-0574-2007
Recall Event ID 37170
Product Classification Circulatory Support System - Product Code DSQ
ProductAB5000 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 ContactWilliam 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
ActionAbiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Quantity in Commerce55 units
DistributionWorldwide, including USA, Japan, Germany, Australia, and Mexico.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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