Medtronic Navigation, Inc. recalls
12 federal recalls on file, showing the 4 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Navigation, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-10-16FDA-DeviceClass IIMedtronic Biopsy Needle Kit recalled for tracking defect
Medtronic Biopsy Needle Kits (model 9733068) contain reflective material that may vary in quality, which could prevent the navigation system from properly detecting and tracking the spheres during procedures. This affects approximately 3,746 units distributed across the US and internationally.
- 2026-10-16FDA-DeviceClass IIMedtronic NDI Passive Spheres recalled for tracking detection failure
Medtronic NDI Passive Spheres used in surgical navigation systems contain a variation in their reflective material coating. This defect may prevent the navigation system from properly detecting and tracking the spheres during surgery, potentially affecting surgical guidance and accuracy.
- 2026-10-16FDA-DeviceClass IIMedtronic NDI Passive Spheres recalled for tracking detection issue
Medtronic NDI Passive Spheres used in surgical navigation systems contain a variation in their reflective material coating. This variation may prevent the navigation system from reliably detecting and tracking the spheres during surgery.
- 2026-10-16FDA-DeviceClass IIMedtronic NDI Passive Spheres recalled for tracking detection failure
Medtronic NDI Passive Spheres used in surgical navigation systems contain inconsistencies in their reflective material coating. This variation may prevent the navigation system from accurately detecting and tracking the spheres during procedures, which could compromise surgical guidance.
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