|
Class 2 Device Recall Abiomed |
|
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.
|
|
|
|