Z-0574-2007

AB5000 Console Circulatory Support System Catalog Number: 0015-0000

Name: Z-0574-2007 AB5000 Console Circulatory Support System Catalog Number: 0015-0000
Creator: Abiomed, Inc.
Published: 2007-01-08
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2007-01-08 / Terminated / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of AB5000 Console Circulatory Support System Catalog Number: 0015-0000 on 2007-01-08. The reason FDA records is "Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source". 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-0574-2007
Status: Terminated
Initiated: 2007-01-08
Posted: 2007-03-07
Terminated: 2008-02-07
Recalling firm: Abiomed, Inc.
Product: AB5000 Console Circulatory Support System Catalog Number: 0015-0000
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Quantity in commerce: 55 units
Distribution: Worldwide, including USA, Japan, Germany, Australia, and Mexico.
Product codes and lots: Serial Numbers: 5261- 5317

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)