Class 1 Recall: Medtronic Intrathecal Catheter, Model 8731 and Intrathecal Catheter Distal Revision Kit, Model 8598

Date Recall
Initiated:

July 21, 2006

Product:

Medtronic Intrathecal Catheter, Model 8731 (part of infusion systems using Medtronic implantable pumps) and Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598.

Use:

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.

Recalling Firm:

Medtronic Neurological
800 53 rd Ave NE
PO Box 1250
Minneapolis , Minnesota 55440-1250

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.

Public Contact:

Medtronic Neurological
Tech Services
1-800-707-0933
Number is available 24 hours/day, 7 days/week

FDA District:

Minneapolis

FDA Comments:

• An Urgent Worldwide Medical Device Recall letter was sent to affected customers on 7/20/06 for delivery on 7/21/06. The letter described the issue, identified the affected product and listed action required by the customer.
• Affected devices are to be removed from inventory, quarantined and returned to Medtronic.

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.