Z-1914-2009

Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory...

Name: Z-1914-2009 Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory...
Creator: Abiomed, Inc.
Published: 2009-05-08
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2009-05-08 / Terminated

FDA source

Abiomed, Inc. began a recall of Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from... on 2009-05-08. The reason FDA records is "The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1914-2009
Status: Terminated
Initiated: 2009-05-08
Posted: 2009-09-01
Terminated: 2012-01-26
Recalling firm: Abiomed, Inc.
Product: Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition.
FDA root cause: Finished device change control
Action: Abiomed notified customers via an Urgent - Voluntary Medical Device Field Removal Notice on May 8, 2009 advising users that the Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. The letter stated that customers may continue to support patients with the AB Portable Driver during the process since the failure has not occurred during patient support. An Abiomed Field Service Engineer will contact customers and arrange for a temporary exchange for the affected driver with a corrected driver. The firm recommends that customers switch the patient to hand pump support and switch patient to backup driver until they can confirm that the Driver(s) has been corrected by an Abiomed Field Service. Questions are to be directed to Michael O'Hara at 978-646-1543 or a Field Service at 800-554-8666.
Quantity in commerce: 18 units
Distribution: Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.
Product codes and lots: Serial numbers: AF0013 - AF0015, AF0017, AF0018, AF0020, AF0022-AF0024, AF0028, AF0030, AF0037, AF0038, AF0043, AF0049, and AF0053 - AF0055.

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)