Medtronic Intrathecal Catheter, Model 8731 and Intrathecal Catheter Distal Revision Kit, Model 8598
Class 1 Recall
|Date Recall Initiated:||July 21, 2006|
Medtronic Intrathecal Catheter, Model 8731 (part of infusion systems using Medtronic implantable pumps) and Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598.
The model 8731 and 8598 are used with Medtronic implantable pumps. They are indicated for use when patient therapy requires the chronic intrathecal infusion of drugs approved for use with the Medtronic implantable pumps.
|Reason for Recall:||
The tip of the catheter may be dislodged during implantation. Dislodgment of the tip can result in the risk of infection or other potentially serious adverse health consequences, and or death.
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.
|The firm is preparing additional information for health care professionals. When available, the link to this information will be provided. If there are any concerns regarding this recall, please contact the Medtronic Neurological Tech Services at 1-800-707-0933. This telephone number is available 24 hours per day, 7 days per week.|