Medscape reported, “The US Food and Drug Administration (FDA) has issued a Class I recall for certain lots of implantable infusion pumps manufactured by Medtronic, which are used in patients undergoing therapy that requires the constant delivery of drugs or fluids.” Initiated on Jan. 14, “the recall was issued for Medtronic SynchroMed II (model number 8637) and SynchroMed EL Implantable Infusion Pump (model numbers 8626 and 8627) and Refill Kits (model numbers 8551, 8555, 8561, 8562, 8564, 8565, and 8566).” Medscape noted, “The problem with the devices is the potential for ‘pocket fills’ to occur, in which the drug is injected into the pump pocket (the area under the skin where the pump is placed) instead of the pump.
From the American Association for Justice news release.
