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U.S. Department of Health and Human Services

Safety

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Medtronic Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit

Medtronic Model 8731 Intrathecal Catheter
Medtronic Model 8598 Intrathecal Catheter Distal Revision Kit

Audience: Hospital operating room staff and other healthcare professionals, and hospital risk managers

[UPDATE 09/08/2006] Recall classified as Class I.

[Posted 07/21/2006] Medtronic and FDA notified healthcare providers of a voluntary recall of Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit. Medtronic is recalling these products because the platinum-iridium tip may be dislodged by the guide wire during implantation. Dislodgement of the tip can result in the risk of infection or other potentially serious adverse health consequences.

[July 2006 – Dear Healthcare Provider Letter – Medtronic]

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