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U.S. Department of Health and Human Services

Class 2 Device Recall Abiocor

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  Class 2 Device Recall Abiocor see related information
Date Initiated by Firm June 13, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on October 08, 2008
Recall Number Z-2304-2008
Recall Event ID 48724
HDE Number H040006 
Product Classification Artificial Heart - Product Code LOZ
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.
Code Information Serial Number:  1028043
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information Contact
978-777-5410 Ext. 225
Manufacturer Reason
for Recall		 Subassembly incorrectly aligned
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE Database HDEs with Product Code = LOZ and Original Applicant = ABIOMED, INC.
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