Medtronic Model 8598 intrathecal catheter distal revision kit

Medtronic intrathecal tip catheters, Medtronic intrathecal catheter distal revision kits

The Medtronic Model 8598 intrathecal catheter distal revision kit, containing an implantable drug pump catheter, was pulled from the U.S. market in July, 2006 after the company received 22 reports of catheter tips dislodging in the spines of patients implanted with the devices. On September 8, 2006, the FDA upgraded the recall to a Class I, its most serious recall classification for medical devices.

A Class I recall is issued when a product is considered to have a high probability of causing personal injury or death to a consumer. The catheter tip is made of platinum-iridium and may be dislodged by the guide wire during implantation. Dislodgement could raise the risk of infection or other serious health problems in patients implanted with the devices.

Implanted devices have not been recalled at this time. According to the “Dear Doctor” letter issued by Medtronic, Inc., most patients with dislodged catheter tips had them remaining in the intrathecal space. Patients who reported adverse incidents with Medtronic catheters complained of post-operative leg pain and chronic back pain.