Medtronic Issues Class I Recall for Sutureless Connector Intrathecal CathetersSep 16, 2009 | Parker Waichman LLP
Medtronic Inc. is recalling Sutureless Connector (SC) intrathecal catheters. 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.
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.
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.
The clinical manifestations of an incomplete connection of an SC catheter to an IsoMed pump may include, but are not limited to, drug or cerebrospinal fluid (CSF) leakage into surrounding tissue, resulting in tissue damage, loss of or change in therapy, a return of underlying symptoms, drug withdrawal symptoms, a severe ("spinal") headache, and/or a clinically significant or fatal drug underdose. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. The IsoMed pump is not FDA approved in the United States for the administration of baclofen.
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.
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.