Abiomed, Inc., AB5000 Circulatory Support System
Recall Class: Class I
Date Recall Initiated: December 16, 2009
Product: Abiomed AB5000 Circulatory Support System
|Catalog Number||Serial Numbers|
|0015-0000||AD5001 through AD5496,
except AD5006 and AD5018
These products were manufactured and distributed between May 2003 and December 2009.
This product supplies power to disposable blood pumps used to support the left and/or right sides of the heart.
22 Cherry Hill Drive
Danvers, Massachusetts 01923
Reason for Recall:
The computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death.
Customers may contact the company at 1-800-554-8666.
FDA District: New England
At the start of the recall, the company phoned their customers and followed up with a letter dated January 27, 2010. The sales representatives delivered the letter at the time the product repairs were carried out.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.