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.
This recall has been terminated (originally issued March 4, 2010).
- Company
- Abiomed, Inc.
- Recall Initiated
- December 16, 2009
- Posted
- March 4, 2010
- Terminated
- July 2, 2014
- Recall Number
- Z-0824-2010
- Quantity
- 496 units
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Console shut down with no audible alarm
Distribution
Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
Lot / Code Info
Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
Root Cause
Process control
Action Taken
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.
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