Leksell Stereotactic System 1000689Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07340048305600), received between Jan 12, 2023 and Jun 18, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION PROVIDED BY FDA - REFERENCE NUMBER MW5150997. PATIENT UNDERGOING BILATERAL DBS ELECTRODE IMPLANT USING LEKSELL FRAME. ONE ELECTRODE WAS IMPLANTED, AND CT USED TO CHECK PLACEMENT. ERROR WAS GREATER THAN ACCEPTABLE OR EXPECTED. THE SPARE ARC/RING WAS STERILIZED, AND THE ELECTRODE WAS REIMPLANTED. ERROR WAS IMPROVED, BUT WAS NOT ACCEPTABLE AND NOT EXPLAINABLE BY HUMAN ERROR OR NATURAL DEVIATIONS. THE INCISION WAS CLOSED. INTENSIVE TROUBLESHOOTING WAS PERFORMED. MY PARTNER WAS CONSULTED AS WELL FOR ADDITIONAL PERSPECTIVES ON CAUSES. ADDITIONAL SCANNING, AND "PHANTOM" TARGETS THAT WERE NON-INVASIVE WERE TARGETED WITH THE ARC/RING. THE LEKSELL FIDUCIAL BOX WAS TESTED, WITH HIGH BUT NOT UNACCEPTABLE ERROR PER NAVIGATION SYSTEM. OPERATION WAS ABORTED DUE TO LACK OF FUNCTIONING EQUIPMENT; MORE THAN ONE POSSIBLE MALFUNCTIONING PIECE OF EQUIPMENT, WITH A NON-LINEAR ERROR THAT COULD NOT BE RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 22282535 ↗
• DeathJan 12, 2023Adverse 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 BLEEDING OCCURING DURING DBS (DEEP BRAIN STIMULATION) SURGERY WHICH LED TO THE PATIENT BEING PLACED IN INTENSIVE CARE POST-OPERATIVELY AND LATER DIED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16145661 ↗

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, Classified
  Elekta 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, Classified
  Elekta 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, Classified
  Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part