Atrium MedicalThe 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 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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