AB5000 Console Circulatory Support System Catalog Number: 0015-0000
FDA Recall Z-0574-2007 · Posted 2007-03-07
Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeDSQ
Date Initiated2007-01-08
Date Terminated2008-02-07
Product Quantity55 units
Reason for Recall
Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
Firm Action
Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Japan, Germany, Australia, and Mexico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.