Leksell Stereotactic System 912877Recalls & reported problems
Elekta Instrument AB · DISPOSABLE INSERTS 4 PCS · Class 2
All models of Leksell Stereotactic System (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340048304474), received between Apr 1, 2021 and Apr 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K152558); 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 16, 2026.
Most reported problems
Device problems
- Connection Problem1
- Material Integrity Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2021Connection Problem; Material Integrity Problem; Material Integrity Problem
THE CUSTOMER REPORTED THAT THE FIXATION SCREWS DOES NOT FEEL RIGID WHEN MOUNTED IN THE DISPOSABLE INSERTS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11601233 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152558. One submission often covers many models, so check the product and lot details in each record.
- Z-0227-2025 · Sep 25, 2024 · Open, ClassifiedElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for
- Z-1397-2024 · Mar 15, 2024 · Open, ClassifiedElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Ki
- Z-1309-2023 · Mar 1, 2023 · Open, ClassifiedInstructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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