AB5000 Console Circulatory Support System Catalog Number: 0015-0000
FDA device recall Z-0574-2007 · posted 2007-03-07 · Terminated
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
- Action taken
- Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSQ
- Quantity affected
- 55 units
- Distribution
- Worldwide, including USA, Japan, Germany, Australia, and Mexico.
- Date initiated
- 2007-01-08
- Date posted
- 2007-03-07
- Date terminated
- 2008-02-07
- Location
- Danvers, MA
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