Posted On: September 21, 2009

Another Medtronic Recall For Infusion Pumps

In August 2009, Medtronic began informing physicians for the first time that, contrary to the labeling, its Sutureless Connector (SC) intrathecal catheters were incompatible with IsoMed Infusion Pump Model 8472, a drug delivery system for which the catheters were not designed. On September 14, 2009, the US Food and Drug Administration ("FDA") notified Medtronic that it considers the notification a Class I medical device recall, the strongest notice that the FDA can issue, because accidental use of the catheters with the wrong pump may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death. This incompatibility is a design defect and not a result of how the pump is implanted. In fact, it may appear to be connected and secured, but a physical interference between the catheter and the infusion pump may lead to fluids leaking into surrounding tissues and the proper dose of drugs not being delivered.

Continue reading " Another Medtronic Recall For Infusion Pumps " »

Bookmark and Share