Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product is intended to be i
FDA device recall Z-2304-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Subassembly incorrectly aligned
- Action taken
- Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LOZ
- Quantity affected
- 1 unit
- Distribution
- NJ
- Date initiated
- 2008-06-13
- Date posted
- 2008-09-20
- Date terminated
- 2008-10-08
- Location
- Danvers, MA
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