Recall Z-0574-2007 · DSQ Ventricular (Assist) Bypass

Abiomed, Inc.

AB5000 Console Circulatory Support System Catalog Number: 0015-0000

Date	Mar 7, 2007 (initiated Jan 8, 2007)
Status	Terminated
Reason	Unit may alarm ''Low Flow'' and ''Low Pressure'' due to manufacturing material in the pressure source.
Root cause	Other
Action	Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Quantity	55 units
Distribution	Worldwide, including USA, Japan, Germany, Australia, and Mexico.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.