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Medtronic Navigation recalls Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly

What should I do?

Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.

What's the hazard?

Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

What's affected

Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly

Read the official FDA Enforcement Report ↗