Abiomed, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
Serial Number: 1028043
Products Sold
Serial Number: 1028043
Abiomed, Inc. is recalling Abiomed : Abiocor Implantable Heart Replacement Kit System Catalog Number:: 0034-8401-HD The product due to Subassembly incorrectly aligned. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subassembly incorrectly aligned
Recommended Action
Per FDA guidance
Abiomed notified consignee by letter and on site visit on 5/13/08. The unit was removed and replaced.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NJ
Page updated: Jan 10, 2026