The FDA announced that the recall of the Medtronic (NYSE:MDT) StealthStation deep brain stimulation (DBS) software is Class I, the most serious type of recall.
Initiated by Medtronic on Aug. 9, 2019, the recall includes the StealthStation auto-registration feature from its cranial software version 3.0 or newer with StealthStation DBS license or StealthStation S8 software with Stealth DBS License.
Devices impacted by the recall were distributed between Feb. 1, 2016, and May 1, 2019. According to the FDA release, 54 consignees were notified with affected products in the U.S. As of June 1, 2020, a total of 33 medical device reports were identified with 22 related to device malfunction and 11 related to injury.
Medtronic’s StealthStation DBS is used with the NexFrame Stereotactic system and O-arm imaging system to provide images of the brain, helping surgeons navigate tools and implants during a DBS procedure.
The auto-registration feature was reported to experience inaccuracies caused by minor patient movements during the process when used with the NexFrame during a DBS procedure, which may not be detected by a surgeon or the system. This potential flaw could cause inaccurate registration data, which could lead to surgeons inaccurately navigating lead placement during image-guided DBS procedures, possibly resulting in serious or life-threatening patient harm.
Medtronic issued an urgent medical device correction to affected customers on Aug. 9, 2019, advising physicians to weigh the benefits vs. the risks of fiducial-based or fiducial-less registration methods.
The company told physicians to, after the O-arm auto-registration step but prior to using the StealthStation DBS software for navigation, access navigational accuracy by verifying the accuracy of the registration on several known anatomical landmarks. Then, physicians should use the StealthMerge functionality to compare the actual location of the cannula or lead to the surgical plan and use the planning functionality in the software to compare the cannula to the planned trajectory.
Medtronic has added instructions to the label and included an updated training program for physicians to be informed of inaccuracies. The company continues to work with the FDA to determine if further mitigations may be necessary.
Shares of MDT are up 1.3% at $98.34 per share from when the FDA issued its release on June 1 to mid-morning trading today.