Medtronic Pulls Catheters from Market

Medtronic Inc. has recalled its Sutureless Connector (SC) intrathecal catheter because of faulty labeling. According to the medical device maker, the recall was issued after Medtronic discovered that the catheter was incompatible with a certain type of pump as the labeling on the catheter indicates. According to a report in the Minneapolis/St. Paul Business Journal, “The catheter affected is called Sutureless Connector (SC) intrathecal catheter and revision kit models 8709SC, 8731SC, 8578 and 8596SC when it is pared with the IsoMed Pump Model 8472 which is no longer made or marketed for sale. Medtronic stopped making IsoMed infusion pumps in September 2008 as part of a planned product phase out.”

Thus far, the labeling error has led to 10 complaints- some of which resulted in serious medical consequences. The Business Journal reported, “In all 10 reports, medical intervention was required to correct the condition. In one case, a patient died two days following a surgery to fix the catheter’s faulty connection to the pump, “but it cannot be determined whether the cause of death is or is not related to the device,” according to a Medtronic press release.”