The FDA today determined that Atrium Medical’s recall of some of its iCast covered stents is Class I, the most serious kind.
Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the delivery system when the delivery system is being removed from a patient. There are 68,812 devices involved in the recall, including all lots distributed between December 31, 2018 to March 31, 2022.
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