Date Recall Initiated |
June 26, 2008 |
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Product: |
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:
The notification recommended that healthcare professionals:
Please see the firm’s notification dated June 2008, located at: For more information about this recall, please see the company’s press release at: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1222437479990&lang=en_US 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 either online, by regular mail or by FAX.
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Updated October 7, 2008
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