Class 2 Device Recall Abiomed

• Date Initiated by Firm: August 19, 2003
• Date Posted: September 11, 2003
• Recall Status: Terminated 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.
• FEI Number: 1220648
• 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: 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