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U.S. Department of Health and Human Services

Class 1 Device Recall Circulatory Support System

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 Class 1 Recall
Circulatory Support System
see related information
Date Posted March 04, 2010
Recall Status1 Terminated on July 02, 2014
Recall Number Z-0824-2010
Recall Event ID 54167
Premarket Approval
PMA Number
P900023
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
Code Information Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
Recalling Firm/
Manufacturer
Abiomed, Inc.
22 Cherry Hill Dr
Danvers, Massachusetts 01923
For Additional Information Contact Michael O'hara
978-646-1543
Manufacturer Reason
for Recall
Console shut down with no audible alarm
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device. For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.
Quantity in Commerce 496 units
Distribution Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
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.
PMA Database PMAs with Product Code = DSQ and Applicant = ABIOMED CARDIOVASCULAR, INC.
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