Leksell Vantage Stereotactic SystemRecalls & reported problems across all models
Elekta Instrument AB · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Leksell Vantage Stereotactic System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 3
We found 10 models of Leksell Vantage Stereotactic System by Elekta Instrument AB in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2018 and Nov 21, 2025 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (6 reports).
3 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Leksell Vantage Stereotactic System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 19, 2026Open, 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 · names 3 of these models · Recall details · FDA record ↗
- Sep 30, 2025Open, 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 · names 2 of these models · Recall details · FDA record ↗
- Mar 30, 2020Terminated
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
Z-1826-2020 · Root cause: Process design · Recall details · FDA record ↗
Most reported Leksell Vantage Stereotactic System problems
Device problems
- Device Handling Problem6
- Material Separation6
- Compatibility Problem4
- Device-Device Incompatibility3
- Flaked3
- Insufficient Device Problem Information3
- Manufacturing, Packaging or Shipping Problem3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Known Impact Or Consequence To Patient6
- Insufficient Information5
- No Patient Involvement3
- No Consequences Or Impact To Patient2
- No Information2
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
Leksell Vantage Stereotactic System models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Leksell Vantage Stereotactic System 1054958Neurological stereotaxic Instrument2 recalls0 reports
- Leksell Vantage Stereotactic System 1054956Neurological stereotaxic Instrument1 recall8 reports
- Leksell Vantage Stereotactic System 1055007Neurological stereotaxic Instrument1 recall1 report
- Leksell Vantage Stereotactic System 1051632Neurological stereotaxic Instrument1 recall0 reports
- Leksell Vantage Stereotactic System 1051631Neurological stereotaxic Instrument1 recall0 reports
- Leksell Vantage Stereotactic System 1053958Neurological stereotaxic Instrument14 reports
- Leksell Vantage Stereotactic System 1051800Neurological stereotaxic Instrument6 reports
- Leksell Vantage Stereotactic System 1072447Neurological Stereotaxic Instrument2 reports
- Leksell Vantage Stereotactic System 1519676Neurological stereotaxic Instrument1 report
- Leksell Vantage Stereotactic System 1054250Neurological stereotaxic Instrument1 report
Recent Leksell Vantage Stereotactic System adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 18, 2025Dent in Material; Dent in Material
THE CUSTOMER REPORTED THAT THE SUPPORT ARC SHIFTED DURING OPERATION. DURING AN OPERATION, THE ARC SUPPORT SHIFTED AND AFTER THREE TIMES THIS PROBLEM PERSISTED, WHICH ALSO RESULTED IN AN ELECTRODE BEING PLACED INCORRECTLY. WORN PARTS WERE REPLACED AND THE LEAD WAS REPLACED WITHOUT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282536 ↗MalfunctionJun 18, 2025Dent in Material; Dent in Material
THE CUSTOMER REPORTED THAT DURING A DBS OPERATION THE Z-SCALE SHIFTED 2-3 MM. SCREWS HAD TO BE CHANGED TO ANOTHER LENGTH TO BE ABLE TO FASTEN THE Z-SCALE AND TO CONTINUE THE OPERATION. THIS WAS NOTICED BEFORE LEADS WERE INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282532 ↗MalfunctionJun 18, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT A NURSE MANAGED TO ATTACHED THE FRAME HOLDER INCORRECTLY RESULTING IN DBS ELECTRODE BEING MISPLACED BY ~1CM. THE POSITION WAS CORRECTED USING A DIFFERENT FRAME HOLDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282531 ↗MalfunctionJun 12, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT THE VANTAGE FRAME SLIPPED, NOTED PRIOR TO TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192869 ↗MalfunctionJun 12, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT THE VANTAGE FRAME HAD SLIPPED ON 4 DIFFERENT OCCASIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192868 ↗MalfunctionJun 12, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT THE VANTAGE FRAME SLIPPED, AND NOTED DURING POSITIONING OF THE PATIENT ON PPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192867 ↗MalfunctionJun 11, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT SOME OF THE MILLIMETER MARKINGS ON THE X-AXIS HAVE BEEN WASHED OFF DURING PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185963 ↗MalfunctionJun 11, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT CHIPPED AND FADING PAINT IN THE ARC ENGRAVINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185157 ↗MalfunctionJun 11, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE NUMBERS IN THE RING OF THE ARC SUPPORT HAVE FALLEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185155 ↗MalfunctionJun 11, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT SOME OF THE MILLIMETER MARKINGS ON THE X-AXIS HAVE BEEN WASHED OFF DURING PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183361 ↗MalfunctionJun 11, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT CHIPPED AND FADING PAINT IN THE ARC ENGRAVINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183360 ↗MalfunctionJun 11, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE NUMBERS IN THE RING OF THE ARC SUPPORT HAVE FALLEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183357 ↗MalfunctionJun 16, 2023Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem
THE CUSTOMER REPORTED THAT A PATIENT BECAME DISENGAGED FROM THE HEAD FRAME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17143049 ↗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 ↗
Other Elekta Instrument AB products
All Elekta Instrument AB devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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