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.
FDA Recall Z-0824-2010 · Posted 2010-03-04
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Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeDSQ
Date Initiated2009-12-16
Date Terminated2014-07-02
Product Quantity496 units
Reason for Recall
Console shut down with no audible alarm
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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