Date Initiated by Firm |
December 16, 2009 |
Date Posted |
March 04, 2010 |
Recall Status1 |
Terminated 3 on July 02, 2014 |
Recall Number |
Z-0824-2010 |
Recall Event ID |
54167 |
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 MA 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 |
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 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.
|
PMA Database |
PMAs with Product Code = DSQ and Original Applicant = ABIOMED CARDIOVASCULAR, INC.
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