FDA ANNOUNCES RECALL OF MEDTRONIC SPINAL PAIN DEVICES

The FDA announced July 21 a worldwide recall of Medtronic's model 8731 Intrathecal Catheter and model 8598 Intrathecal Catheter Distal Revision Kit.

Intrathecal catheters are used to treat pain by delivering medication directly into the cerebrospinal fluid, or intrathecal space, that surrounds the spinal cord.

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, the FDA said.

The recall was issued after the firm received 22 reports of tip dislodgements, including a report of one incident of postoperative leg pain that could have been related to a dislodged catheter tip in the intrathecal space, the FDA said.

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.

Medtronic's Dear Healthcare Provider letter can be viewed at www.fda.gov/medwatch/safety/2006/Medtronic8731_cath_recall_Letter_Rev16.pdf (http://www.fda.gov/medwatch/safety/2006/Medtronic8731_cath_recall_Letter_Rev16.pdf).