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U.S. Department of Health and Human Services

Class 2 Device Recall Abiomed

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  Class 2 Device Recall Abiomed see related information
Date Initiated by Firm August 19, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on October 15, 2003
Recall Number Z-1222-03
Recall Event ID 27071
PMA Number P900023 
Product Classification Ventricular (Assist) Bypass - Product Code DSQ
Product BVS 5000t Bi-Ventricular Support System Transport/Backup Console
Catalog Number: 0050-000
Code Information Serial Numbers: 3042, 3045-3047, 3049-3080.
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Drive
Danvers MA 01923
For Additional Information Contact Tracy Palmer Burns
978-777-5410
Manufacturer Reason
for Recall		 Bi-Ventricular support system may switch to battery when primary voltage (AC) is available
FDA Determined
Cause 2		 Other
Action Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.
Quantity in Commerce 36
Distribution Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX
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.
PMA Database PMAs with Product Code = DSQ and Original Applicant = ABIOMED CARDIOVASCULAR, INC.
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