Abiomed Inc. (NSDQ:ABMD) was hit with a Class I recall of its AB5000 Circulatory Support System after receiving reports that the computer supplying power to the company’s disposable heart pumps may shut down without warning.
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 could cause serious injury or death.
Food & Drug Administration officials initiated the recall in December and Abiomed officials soon began informing customers by telephone, later following up with a letter dated Jan. 27, 2010. The sales representatives delivered the letter at the time the product repairs were carried out, the agency said.
Danvers, Mass.-based Abiomed received pre-market approval supplement for a portable driver for the AB 5000 in March 2009, allowing for immediate commercial shipment of the device to U.S. hospitals for in-hospital and transport use. The AB5000 device — as well as its predecessor BVS 5000 Biventricular Support System introduced 17 years ago — are used for temporary support of acute heart failure in patients following heart attacks, during open-heart surgery or when the myocardium, the middle layer of the heart wall, becomes inflamed.
Abiomed markets the AB5000 and BVS 5000 systems as the only commercially available cardiac assist devices approved by the FDA for all indications where heart recovery is the intended outcome. The company does not provide specific sales numbers for either device, although in recent quarters it has said sales have slipped as the company has concentrated on development of other products, including the AbioCor replacement heart and the Impella cardiac-assist device.
Through the nine months ended Dec. 31, 2009, Abiomed reported $62.7 million in total revenues.