FDA has issued a Class I Recall on Medtronic Neuromodulation INDURA IP intrathecal catheters, sutureless pump connector revision kits and intrathecal catheter pump segment revision kits.
There are potential misconnections of the Medtronic sutureless connector (“SC”) catheters from the catheter port on the medtronic pump. These misconnections have resulted in a blockage (occlusion) between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector.
These intrathecal catheter or intrathecal catheter revision kits use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter is part of an infusion system that stores and delivers drugs to the patient. A blockage or disconnection would result in an interruption of the medication supply to the patient.
Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. Central Daylight Time.
Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday – Friday, 8 a.m. to 5 p.m. Central Daylight Time.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.