Medtronic drug pump given Class I warning
Medtronic’s implantable infusion pumps, SynchroMed and IsoMed, have been assigned a Class I recall by the Food and Drug Administration. Physicians have been and are currently being informed about an increase in the rate of inflammatory mass cases in patients receiving drugs through Medtronic’s infusion pumps. The Food and Drug Administration defines a Class I recall as a situation in which there is a reasonable probability that use of the product will cause injury or death. In mid-January Medtronic sent an update to inform clinicians of the possibility of inflammatory mass cases. The inflammatory mass develops near the tip of the catheter attached to the pumps. Medtronic said the risk of an inflammatory mass has been part of the product labeling since 2001.
