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.
This recall has been terminated (originally issued September 20, 2008).
- Company
- Abiomed, Inc.
- Recall Initiated
- June 13, 2008
- Posted
- September 20, 2008
- Terminated
- October 8, 2008
- Recall Number
- Z-2304-2008
- Quantity
- 1 unit
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Subassembly incorrectly aligned
Distribution
NJ
Lot / Code Info
Serial Number: 1028043
Root Cause
Process control
Action Taken
Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.
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