A health alert issued in June by Medtronic regarding problems with catheters used with its implantable intrathecal drug pumps has been deemed a Class I recall by the Food & Drug Administration (FDA), the agency’s most serious type. Medtronic says it has received 83 reports of infusion system difficulties worldwide that have been attributed to either an occlusion or a disconnection of the sutureless catheter from the pump. In one case, a patient died from acute baclofen withdrawal related to complications from an improperly connected catheter.
Neither the June health alert nor the FDA’s classification Friday called on patients to have devices removed, and hospitals and doctors are not being asked to return unused products. However, patients who experience the catheter problems described in the recall will require a surgical procedure for correction, Medtronic said. (more…)
