Surgical Navigation Tracker Subject to Weld Failure and Navigation Inaccuracy
A surgical navigation tracker used in neurosurgery may experience weld failure, leading to navigation inaccuracy, prolonged procedure time, and potential tissue injury. 98 affected units were distributed across US and international healthcare facilities.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. No reported injuries or hospitalizations. The device may experience weld failure leading to navigation inaccuracy and potential tissue injury. Fits rubric criterion for High severity: risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Stealth Autoguide Tracker, Model 28248, is a surgical navigation instrument used in neurosurgical procedures. It is also included in the Stealth Autoguide Basic Instrument Kit (Model 9736188) and the Bundle Autoguide Reg Kit. A total of 98 units are subject to this recall.
The tracker holds and guides surgical instruments during neurosurgery. The device may experience separation or weld failure at the connection point where the tracker connects to the instrument tube. If weld separation occurs and navigation inaccuracy results, the surgical procedure may be prolonged and tissue injury may occur.
Affected devices were distributed to healthcare facilities in the United States across 20 states and internationally to 12 countries, including Canada, Sweden, Italy, France, Germany, Spain, Czech Republic, United Kingdom, India, Nepal, Japan, Turkey, and China. All lot numbers are included in this recall.
The recalled product
- Product
- Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- weld-failure
- navigation-inaccuracy
- tissue-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distributed in 21 states:
- AZ
- CA
- FL
- IL
- IN
- KS
- KY
- MI
- MN
- MO
- MS
- NE
- NV
- OH
- OK
- OR
- SC
- TX
- UT
- VA
- WA
Related recalls
Same category
- ModerateProvena Midline Catheters recalled due to deficient manufacturing practices
FDA (Devices) · 2026-07-08
- ModeratePowerPICC Provena Catheters recalled for deficient manufacturing practices
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Recalled Due to Lidocaine Quality Issues
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08