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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 98
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
Related recalls
Same manufacturer · Medtronic Navigation, Inc.
See all →- HighMedtronic Percutaneous Reference Pins May Not Fit Properly
FDA (Devices) · 2025-02-05
- HighStealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
FDA (Devices) · 2024-10-16
- SevereStealth S8 neurosurgical navigation software display error affecting surgical guidance
FDA (Devices) · 2024-05-15
- HighMedtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
FDA (Devices) · 2024-01-17
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17
Same hazard · weld failure
See all →- SevereElectric fat tire trikes recalled after frames broke near a weld
CPSC · 2025-12-18
- High20mm vented vial spikes recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05
- HighChemotherapy bag spikes recalled because port weld may separate and leak
FDA (Devices) · 2025-11-05
- HighDouble port syringe transfer sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05
Similar recalls
- CriticalStealthStation Cranial Software displays inaccurate navigation during brain surgery
FDA (Devices) · 2023-06-14
- HighSPiN Drive Needle Navigation Sensor Malfunction Triggers Procedural Delays
FDA (Devices) · 2023-08-09
- SevereStealthstation and Synergy Cranial surgical navigation system software synchronization error
FDA (Devices) · 2021-12-29
- SevereStealth S8 neurosurgical navigation software display error affecting surgical guidance
FDA (Devices) · 2024-05-15
- HighStryker Recalls Navigation System II-Cart Due to Weld Seam Defect
FDA (Devices) · 2015-06-24
- HighMazor Robotics Recalls Snapshot Tracker Kits Due to Manufacturing Defects
FDA (Devices) · 2020-01-01