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Medtronic Recalls SC Intrathecal Catheters

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Sutureless Connector (SC) intrathecal catheters made by Medtronic Inc. have been recalled because they are incompatible with the IsoMed infusion pump.

Products affected by this recall include the following models: SC Catheter and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the IsoMed Pump Model 8472, which is no longer manufactured and marketed. Medtronic stopped producing IsoMed infusion pumps in September 2008 as part of a planned product phase-out. Other types of intrathecal catheters and intravascular catheters for delivery of chemotherapy are not affected by this issue.

In letters sent to physicians, Medtronic said that that the current SC catheter labeling incorrectly states that SC catheters are compatible with the IsoMed infusion pump. A physical interference between the SC catheter connector and the IsoMed pump prevents the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure. This incompatibility is design related and is not a result of implant technique. This incompatibility may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

To date, Medtronic has received 10 reports related to improper connection of these catheters to an IsoMed pump. In all of these incidents, medical intervention was required to correct the condition. According to the Medtronic press release, one of these  patient died two days following a surgery to fix the catheter’s faulty connection to the pump,  However, the company said it  cannot be determined whether the cause of death is or is not related to the device.

According to a Medtronic press release, the Food & Drug Administration (FDA) has deemed this a Class I recall.  Class I recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

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