Recall Z-0574-2007
Abiomed, Inc. · initiated January 8, 2007
Product
AB5000 Console Circulatory Support System Catalog Number: 0015-0000
Codes / lots: Serial Numbers: 5261- 5317
Reason for recall
Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
FDA-determined cause: Other
Action taken
Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Details
- Recall number
- Z-0574-2007
- Initiated
- January 8, 2007
- Posted by FDA
- March 7, 2007
- Terminated
- February 7, 2008
- Product code
- DSQ – Ventricular (Assist) Bypass
- Quantity
- 55 units
- Distribution
- Worldwide, including USA, Japan, Germany, Australia, and Mexico.
- Recalling firm
- Abiomed, Inc., Danvers, MA