BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
This recall has been terminated (originally issued September 11, 2003).
- Company
- Abiomed, Inc.
- Recall Initiated
- August 19, 2003
- Posted
- September 11, 2003
- Terminated
- October 15, 2003
- Recall Number
- Z-1222-03
- Quantity
- 36
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Bi-Ventricular support system may switch to battery when primary voltage (AC) is available
Distribution
Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX
Lot / Code Info
Serial Numbers: 3042, 3045-3047, 3049-3080.
Root Cause
Other
Action Taken
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.
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