microTargeting™ Insertion Tube with Stylet
FHC, INC. · Model 66-IT(MD1)-00509 · UDI-DI 00873263005095
HAW
Prescription
1
510(k) clearances
42,962
Adverse events (104 deaths)
201
Recalls
246
Facilities
Description
microTargeting Insertion Tube with Stylet, nonsterile
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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Get your free API keyRead the docsData 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.