Abiomed AB5000 Circulatory Support System in Class I Recall
Date Published: Friday, March 12th, 2010
Abiomed, Inc.’s recall of its AB5000 Circulatory Support System has been deemed a Class I recall by the Food & Drug Administration (FDA). 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.
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.
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.
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.
Customers seeking additional information about this recall may contact the company at 1-800-554-8666.
This entry was posted
on Friday, March 12th, 2010 at 8:02 am and is filed under Defective Medical Devices, Product Recalls, Recalled Medical Devices.
Abiomed AB5000 Circulatory Support System in Class I Recall
Date Published: Friday, March 12th, 2010
Abiomed, Inc.’s recall of its AB5000 Circulatory Support System has been deemed a Class I recall by the Food & Drug Administration (FDA). 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.
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.
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.
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.
Customers seeking additional information about this recall may contact the company at 1-800-554-8666.
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This entry was posted
on Friday, March 12th, 2010 at 8:02 am and is filed under Defective Medical Devices, Product Recalls, Recalled Medical Devices.
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