Merit Medical Systems Inc, 1721504-08.01.22-004R, CorVocet Biopsy System

Merit Medical Systems, Inc. is voluntarily conducting a recall of the CorVocet™ Biopsy System due to a product defect resulting from incorrect assembly. This assembly error may occur when components are misaligned due to an issue with the manufacturing assembly equipment. In rare instances, the needle may eject from incorrectly assembled CorVocet™ biopsy devices when triggered outside the body, which results in the potential for a user or patient needle stick injury. The IFU includes the following precaution: “Never test the product by firing into the air. Damage may occur to the device and could result in patient and/or user injury.”