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U.S. Department of Health and Human Services

Medical Devices

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Medtronic INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit

Class 1 Recall
Date Recall
Initiated:
June 26, 2008
Product:
  • Medtronic INDURA 1P Intrathecal Catheter, Model 8709SC
  • Medtronic Intrathecal Catheter, Model 8731SC
  • Medtronic Sutureless Pump Connector Revision Kit, Model 8578
  • Medtronic Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC

These products were manufactured beginning on November 21, 2006 and are still being manufactured, and were distributed beginning in January 22, 2007 and are still in distribution.

This recall does not include the Medtronic MiniMed infusion pumps.

Use:

The 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 parenteral drugs to the intrathecal space.

Recalling Firm:

Medtronic Neuromodulation
800 53rd Avenue NE
Minneapolis, Minnesota 55440-1250

Reason for Recall:

This recall is being conducted due to potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the 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.

Public Contact:

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.

FDA District:

Minneapolis

FDA Comment:

In June 2008, the company sent a notification to healthcare professionals which described the problem. The notification identified the:

  • affected catheters
  • revision kits’ model numbers
  • associated implantable infusion pumps

The notification recommended that healthcare professionals:

  1. verify cerebrospinal fluid (csf) backflow through the catheter
  2. ensure alignment of sutureless connector to the pump
  3. snap the sutureless connector into place
  4. tug and rotate to test the connection
  5. follow recommendations for managing patients with implanted “SC” catheters
  6. provide ongoing education of patients and caregivers of the signs and symptoms of drug underdose and withdrawal

For more information about this recall, see the nearby links.

Class 1 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.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program. See the nearby link to MedWatch.