Abiomed, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
Products Sold
Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
Abiomed, Inc. is recalling Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. due to Console shut down with no audible alarm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Console shut down with no audible alarm
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026