FDA issues Class I recall for software glitch in Medtronic's surgery StealthStation

The U.S. Food and Drug Administration classified a software glitch with Medtronic's StealthStation S8 surgical navigation system as a Class I recall, the most serious issued by the agency.

StealthStation is a tool to assist surgeons, allowing them to precisely track the location of surgical instruments within a patient's body during a procedure.

"Medtronic identified a software anomaly in StealthStation S8," said Erika Winkels, a spokeswoman for Medtronic. "This anomaly only impacts where the surgical planning data is displayed, and there is no impact on the accuracy of the anatomical navigation information,"

Planning data shows the placement and path of surgical instruments outlined in advance by the surgeon. The recall applies to StealthStation S8 Application Version 2.0 and 2.0.1.

Unlike recalls of food and consumer goods, medical device recalls typically don't call for the product to be returned to the manufacturer.

"Medtronic has released an updated software, version 2.1, that addresses the anomaly, and we are working with all impacted customers to upgrade their system software to the new version," Winkels said.

StealthStation can be used with a number of different procedures including biopsies, tumor resection, catheter placement, deep brain stimulation lead placement and spinal operations. Winkels said that the software glitch only affected cranial and ENT (ear, nose and throat) procedures.

Medtronic Navigation Inc. issued an "urgent medical device correction letter" about StealthStation on Sept. 27.

The FDA issued its Class I recall status this week.

"The use of affected product may cause serious adverse health consequences, including death," the FDA notice said.

There have been no reported injuries or deaths related to the issue. A total of 2,109 devices were recalled in the U.S.