FDA Announces Recall Of Medtronic Spinal Pain Devices

On July 21, 2006, the FDA announced a worldwide recall of Medtronic’s model 8731 Intrathecal Catheter and model 8598 Intrathecal Catheter Distal Revision Kit.
    Minneapolis, MN-based Medtronic is recalling the two product models because the platinum-iridium tip on the devices may be dislodged by the guidewire when they are being implanted, resulting in a risk of infection or other potentially serious adverse health consequences.
   According to the FDA, the recall was issued after the firm received 22 reports of tip dislodgements.
    The recall applies to 45 lots of nonimplanted catheters and revision kits in the U.S. with use-by-dates (UBDs) on or before Aug. 28, and one lot of kits with UBDs of Oct. 28, the FDA said. Outside the U.S., the recall applies to both devices with UBDs on or before Aug. 28.