Leksell Stereotactic System 1002248Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07340048306348), received between Jul 25, 2018 and Feb 1, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Mar 1, 2023Class IIOpen, Classified

   The incorrect IFU was distributed with the devices.

   Z-1309-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630647 ↗
• MalfunctionNov 15, 2019Use of Device Problem; Use of Device Problem; Defective Device

  THE CUSTOMER REPORTED A LEKSELL SYSTEM INACCURACY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9326679 ↗
• MalfunctionJul 25, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT DURING THE MR SCAN WHILST USING THE FRAME PATIENTS HAVE EXPERIENCED BURN MARKS. BASED ON THE AVAILABLE INFORMATION ACTUAL INJURY HAS OCCURRED.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 7718229 ↗

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