Z-0824-2010

Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers...

Name: Z-0824-2010 Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers...
Creator: Abiomed, Inc.
Published: 2009-12-16
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2009-12-16 / Terminated / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term... on 2009-12-16. The reason FDA records is "Console shut down with no audible alarm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0824-2010
Status: Terminated
Initiated: 2009-12-16
Posted: 2010-03-04
Terminated: 2014-07-02
Recalling firm: Abiomed, Inc.
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.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Console shut down with no audible alarm
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)