FDA Issues Recall of Medtronic Infusion Pump
A potential for life-threatening blockages has prompted the recall of the Medtronic Infususion Pump. The FDA and Medtronic, Inc. issued a Class I Recall of the Medtronic Infusion Pain Pump, Neuromodulation INDURA IP. This recall includes the following models: intrathecal catheter, the suturless pump, and the intrathecal catheter pump segment revision kit.
Unfortunately, this is a serious recall, since a Class I Recall is the most serious type of product recall issued by the FDA, Food and Drug Administration. A Class I Recall involves situations where there is a reasonable probability that death or a serious injury will occur from using the product.
How are the recalled Products used?
The intrathecal catheter revision kits or the intrathecal catheter use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter is a part of an infusion system. The catheter delivers and stores drugs into a specific space.
What promoted the Recall?
The recall of the Medtronic Infusion Pump was due to the potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. Reports have shown these misconnections to have caused a blockage between, the catheter port on the pump, disconnection from the pump connector and the sutureless pump connector.
The following product models are included in the Recall:
Sutureless Pump; Connector Revision Kit, Model 8678;
Intrathecal Catheter, Model 8731SC;
Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC
Intrathecal Catheter, Model 8709SC
It is important to note that this recent recall does not include the MiniMed infusion pumps made by Medtronic.
What should you do if you have a Pain Pump?
If you or a loved one have used a Pain Pump since January 22, 2007, contact your physician to ask questions. You can also contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. Central Daylight Time.
Click here to read FDA Recall of Medtronic Pain Pump.
