FDA Deems Abiomed Device Recall Class IMar 12, 2010 | Parker Waichman LLP
A Class I recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System.
The AB5000 Circulatory Support System supplies power to disposable blood pumps used to support the left and/or right sides of the heart. According to the recall notice, the computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death.
At the start of the recall, the company phoned their customers and followed up with a letter dated January 27, 2010. According to the recall notice, Abiomed sales representatives delivered the letter at the time the product repairs were carried out.
The Catalog Number affected by this recall is 0015-0000. The recalled devices bear Serial Numbers AD5001 through AD5496, except AD5006 and AD5018. The devices were manufactured and distributed between May 2003 and December 2009.
Class 1 recalls is the Food & Drug Administration's 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.
Customers seeking additional information about this recall may contact the company at 1-800-554-8666.