Leksell Vantage Stereotactic System 1053958Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07340048304399), received between Nov 13, 2018 and Nov 21, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE THE PLANNED POSITION WAS OUT OF SCOPE ABOUT 3MM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615856 ↗
• MalfunctionMay 11, 2023Failure to Align; Compatibility Problem; Unintended Compatibility; Failure to Align; Compatibility Problem; Unintended Compatibility

  THE CUSTOMER HAS REPORTED A POSITION DISCREPANCY WHEN POSITIONING DBS ELECTRODE. THE CUSTOMER HAS BEEN USING FHC'S MICRODRIVE (THIRD PARTY). ELEKTA IS NOT CLAIMING COMPATIBILITY WITH FHC'S MICRODRIVE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16910418 ↗
• MalfunctionJan 11, 2023Device-Device Incompatibility; Compatibility Problem; Unintended Compatibility; Device-Device Incompatibility; Compatibility Problem; Unintended Compatibility

  THE CUSTOMER HAS REQUESTED AN ACCURACY CHECK AS THEY HAVE EXPERIENCED ISSUES WITH ACCURACY. THE CUSTOMER HAS BEEN USING ALPHA OMEGA'S (THIRD PARTY], MICRODRIVE, WHICH IS NON-COMPATIBLE WITH LEKSELL VANTAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137999 ↗
• MalfunctionDec 23, 2022Calibration Problem; Device-Device Incompatibility; Compatibility Problem; Calibration Problem; Device-Device Incompatibility; Compatibility Problem

  THE CUSTOMER REPORTED ACCURACY DEVIATIONS WITH LEKSELL VANTAGE DURING SURGERY WITH A SYSTEMATIC ERROR OF ABOUT 2 MM. THE CUSTOMER WAS USING THE NON-COMPATIBLE MICRODRIVE FROM THE MANUFACTURER ALPHA-OMEGA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041694 ↗
• MalfunctionDec 23, 2022Calibration Problem; Device-Device Incompatibility; Compatibility Problem; Calibration Problem; Device-Device Incompatibility; Compatibility Problem

  THE CUSTOMER REPORTED ACCURACY DEVIATIONS WITH LEKSELL VANTAGE DURING SURGERY WITH A SYSTEMATIC ERROR OF ABOUT 1.6 MM. THE CUSTOMER WAS USING THE NON-COMPATIBLE MICRODRIVE FROM THE MANUFACTURER ALPHA-OMEGA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041678 ↗
• MalfunctionNov 15, 2021Output Problem; Inadequate Lubrication; Inadequate Lubrication

  THE CUSTOMER REPORTED THAT THEY HAVE EXPERIENCED THAT THE VANTAGE ARC GRIB ON THE RIGHT SIDE SEEMS COMPROMISED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810146 ↗
• MalfunctionApr 6, 2021Break; Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTED THAT THE LOCKING OF THE Z-SCALE IS BROKEN. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618771 ↗
• MalfunctionSep 24, 2020Flaked; Material Fragmentation; Flaked

  THE CUSTOMER REPORTED THAT THE PAINT ON THE LEKSELL VANTAGE ARC WAS FLAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10579054 ↗
• MalfunctionApr 3, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING INSPECTION IT WAS FOUND THAT SCREWS WERE INCORRECT POSITIONED ON THE VANTAGE SYSTEM

  Patient problems: No Patient Involvement

  MAUDE report 9920824 ↗
• MalfunctionApr 3, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THE INSTRUMENT CARRIER LOCKING PINS WERE MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9920330 ↗
• MalfunctionJan 17, 2020Flaked; Material Integrity Problem; Flaked

  THE CUSTOMER REPORTED DAMAGE TO PAINT ON COMPONENTS RELATED TO THE LEKSELL VANTAGE ARC SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9601383 ↗
• MalfunctionJan 17, 2020Flaked; Structural Problem; Flaked

  THE CUSTOMER REPORTED DAMAGE TO PAINT ON COMPONENTS RELATED TO THE LEKSELL VANTAGE ARC SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9601359 ↗
• MalfunctionJul 12, 2019Positioning Problem; Malposition of Device; Positioning Problem

  THE CUSTOMER REPORTED A SUSPECTED DEVIATION ON DBS POSITION ON RIGHT BRAIN HEMISPHERE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8784336 ↗
• MalfunctionNov 13, 2018No Apparent Adverse Event; Malposition of Device; No Apparent Adverse Event

  A THIRD PARTY SUPPLIER TO A CUSTOMER HAS REPORTED THAT DBS ELECTRODES, WHICH HAVE BEEN IMPLANTED WITH THE LEKSELL VANTAGE FRAME HAVE SHIFTED IN A MEDIAL-POSTERIOR DIRECTION AND A REVISION SURGERY IS REQUIRED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8064589 ↗

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