Local Law Firms Home > Product Liability Overview > Medical Device Defect & Recalls > HeartMate II HeartMate II has been recalled by Thoratec, according to the Food and Drug Administration. The decision initially appeared on the FDA's website March 23. It wasn't known right away why the decision got reposted.
Future implantations, according to the Food and Drug Administration, should adhere to Thoratec's new instructions and cautions. Before the company notified physicians, Thoratec said it received reports of 29 incidents in which the heart pump wasn't correctly connected, resulting in an incidence rate of 0.91%. Five of those cases needed surgical intervention, and in one case the patient passed away.
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