Leksell Vantage Stereotactic System 1054956Recalls & reported problems
Elekta Instrument AB · SUPPORT ARC COMPLETE · Class 2
All models of Leksell Vantage Stereotactic System (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07340048304849), received between Jun 11, 2025 and Jun 18, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Material Separation” (6 reports).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
Recalls naming this device
- 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 ↗
Most reported problems
Device problems
- Material Separation6
- Dent in Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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 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 ↗
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 · TerminatedLeksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- Z-1826-2020 · Mar 30, 2020 · TerminatedLeksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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