A catheter that connects to infusion pumps used to store and deliver medicine into the body is being recalled because its design is incompatible with certain pumps and may cause serious injury or death due to catheter disconnection or blockage at the connection site.
The Class I recall was announced this week by the Food and Drug Association (FDA) and covers INDURA 1P Intrathecal Catheter model 8709SC, Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578; and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. A Class I recall is the most serious type of recall the FDA can give and involves situations in which there is a reasonable probability that use of the products will cause serious injury or death.
The current labeling for the Medtronic Sutureless Connector (SC) catheters and revision kits (known collectively as SC catheters) incorrectly states that SC catheters are intended to be used with Medtronic IsoMed constant-flow infusion pumps. SC catheters can only be used with Medtronic SynchoMed II and SynchoMed EL pumps.
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 feels secure. This may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury and death.
To date, Medtronic has received 10 reports worldwide related to improper connection of an SC catheter to an IsoMed pump. In all 10 reports, medical intervention was required to correct the condition.
Medtronic has provided recommendations in their Medical Device Correction Letter. Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 800-328-0810, Monday – Friday, 8 a.m. to 5 p.m. Central Time.