Dive Brief:
- Medtronic recalled a surgical navigation system used during neurosurgery procedures because of a software error that can cause physicians to use an incorrect measurement for placing biopsy tip stops.
- Medtronic has received 28 complaints related to the problem, according to a Food and Drug Administration notice posted on Wednesday. The company has not received any reports of injuries or deaths.
- The Stealthstation system has been the subject of several recent recalls. Last year, the FDA posted three recalls related to software used with the Stealthstation S7 and S8 surgical navigation platforms.
Dive Insight:
Medtronic’s Stealthstation system is intended to help physicians locate anatomical structures during neurosurgery. It can be used in tumor resections and cranial biopsies and to place depth electrodes in epilepsy treatment or catheters to drain cerebrospinal fluid.
The latest recall is related to an application used with Medtronic’s Stealthstation S8 system. A software error can cause numbers or letters to be missing from the displayed text and replaced by a space during navigation. This can result in the mechanical depth stop being set too short or too long, causing a surgeon to use incorrect measurements.
Performing a cranial procedure using incorrect placement could lead to serious permanent injuries, including brain, nerve or cerebrovascular damage, the FDA said. The agency categorized the recall as Class I, the most serious type.
Medtronic sent a letter to customers on April 10, saying the company plans to issue a software update to fix the error. The recall applies to 876 devices distributed in the U.S.
“A software update to correct this issue is in place and we are deploying it to any impacted [Stealthstation] S8 systems as quickly as possible,” Medtronic spokesperson Rita Greenberg wrote in an email.
The recall is a correction and does not require product removal, according to the FDA’s notice.
Medtronic recalled the Stealthstation S8 application in September because of a software problem that could affect surgical planning data, which could result in proceeding to an incorrect location from the planned target.
The software was also the subject of two Class I recalls in June 2023 because of software anomalies that could happen during cranial biopsies, tumor resection, shunt placement and deep brain stimulation, where displays no longer synchronize with other navigation information.
Stealthstation was also recalled in 2021 and 2020 because of problems with the cranial biopsy procedure software no longer synchronizing with other navigational information on the screen, as well as entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures.