Z-2304-2008

Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is...

Name: Z-2304-2008 Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is...
Creator: Abiomed, Inc.
Published: 2008-06-13
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2008-06-13 / Terminated / root cause: manufacturing process

FDA source

Abiomed, Inc. began a recall of Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and... on 2008-06-13. The reason FDA records is "Subassembly incorrectly aligned". 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-2304-2008
Status: Terminated
Initiated: 2008-06-13
Posted: 2008-09-20
Terminated: 2008-10-08
Recalling firm: Abiomed, Inc.
Product: Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart.
Product code: LOZ Artificial Heart
Reason for recall: Subassembly incorrectly aligned
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.
Quantity in commerce: 1 unit
Distribution: NJ
Product codes and lots: Serial Number: 1028043

Product code LOZ

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)