Leksell Vantage Stereotactic System 1072447Recalls & reported problems
Elekta Instrument AB · LEKSELL VANTAGE FRAME HOLDER · Class 2
All models of Leksell Vantage Stereotactic System (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07340048311410), received between Dec 16, 2019 and Jun 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K190887); 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
Most reported problems
Device problems
- Device Handling Problem1
- Material Too Soft/Flexible1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionDec 16, 2019Material Too Soft/Flexible; Unintended Movement; Material Too Soft/Flexible
DURING VERIFICATION OF VANTAGE FRAME ADAPTER IT WAS OBSERVED THAT THERE IS A RISK OF SHIFTING THE FRAME VERSUS THE ADAPTER IN X-DIRECTION WHEN HOLDING THE FRAME AND ADAPTER ON THE SIDE. THE INTERFACE IS SIMILAR IN THE VANTAGE FRAME HOLDER AND THERE IS A RISK THAT THE SAME OR SIMILAR SHIFT CAN OCCUR DURING HANDLING.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9473261 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K190887. One submission often covers many models, so check the product and lot details in each record.
- Z-2006-2026 · Mar 19, 2026 · Open, ClassifiedBrand Name: Leksell Vantage Arc System REF: 1053958
- Z-0433-2026 · Sep 30, 2025 · Open, ClassifiedBrand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell Vantage" Ste
- 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
- 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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