Leksell Vantage Stereotactic System 1054958Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K171123); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 19, 2026Class IIOpen, Classified

   Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

   Z-2006-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Sep 30, 2025Class IIOpen, Classified

   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

   Z-0433-2026 · Root cause: Process change control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171123. One submission often covers many models, so check the product and lot details in each record.

• Z-2442-2020 · Jun 10, 2020 · Terminated
  Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
• Z-1826-2020 · Mar 30, 2020 · Terminated
  Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument