The SuturelessConnector intrathecalcatheter and the IsoMedconstant-flow fusion pump, when combined, has now been classified as a Class 1 recall by the FDA. The recall was issued after a statement was issued by Medtronic Inc. warning of the risks posed by the catheter and the infusion pump when the two are used together.
Because the Infusion pump and the catheteronly pose a risk when they are combined theyare still able to be produced. The products are also only considered Class 1 recalled when they are combined since they pose no risk when used separately. The recall is about the SC Catheter and Revision Kit models 8709SC, 8731SC, 8578SC, and 8596SC when combined with model 8472 IsoMedPump. The IsoMedPump model 8472 was discontinued in September of 2008.
The SC catheter and the IsoMedPump have a physical interference in between them preventing them from completely connecting to each other, although it may appear that they are connected and even feel secure. The incompatibility is not a result of implant technique but a result the design and can pose a serious risk of death by leading to disruption of revision surgery and therapy.
There have been 10 reports of improper connection of the devices and medical intervention was required in all of the incidents.