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NDI Passive Spheres

Northern Digital Inc · Model 8801320 · UDI-DI 00805832030047

HAW Prescription

510(k) clearances

42,962

Adverse events (104 deaths)

201

Recalls

246

Facilities

Description

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 10 sphere per tray in a pouch. There are 2 tray-in-pouches for a total of 20 spheres.

Recalls

Date	Firm	Reason
2026-08-31	Medtronic Navigation, Inc.	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.
2026-08-31	Medtronic Navigation, Inc.	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.
2026-08-31	Medtronic Navigation, Inc.	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.
2026-08-31	Medtronic Navigation, Inc.	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.
2026-03-19	Elekta, Inc.	Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
2025-11-12	Howmedica Osteonics Corp.	When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an in
2025-09-30	Elekta, Inc.	Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
2024-10-04	FHC, Inc.	A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of
2024-09-25	Elekta Instrument AB	Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same m
2024-03-26	Medtronic Navigation, Inc.	Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.