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Terminated

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.

FDA Recall Z-2304-2008 · Posted 2008-09-20

Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeLOZ
Date Initiated2008-06-13
Date Terminated2008-10-08
Product Quantity1 unit

Reason for Recall

Subassembly incorrectly aligned

Firm Action

Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.

Root Cause

Process control

Distribution Pattern

NJ

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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