NA 4100231000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540068224), received between Jul 24, 2018 and Apr 22, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Detachment of Device or Device Component

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN (B)(6) 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953968 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 0 EVENTS FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163434 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399797 ↗
• MalfunctionOct 28, 2025Material Disintegration; Material Disintegration

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399774 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200897 ↗
• InjuryNov 14, 2024Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT THE PIN WENT INTO THE LEFT NOSTRIL OF THE NURSES FACE AND FRACTURED THE RIGHT ORBITAL FLOOR DURING A CASE AT THE USER FACILITY. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20686233 ↗
• MalfunctionOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495569 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113357 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556925 ↗
• MalfunctionOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17988349 ↗
• MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH.1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401904 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 8 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396880 ↗
• MalfunctionApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS MISSING COMPONENTS DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136863 ↗
• MalfunctionMar 31, 2022Ejection Problem; Ejection Problem

  THE USER FACILITY REPORTED THAT THE DEVICE EJECTED A BUR DURING TESTING PRIOR TO A PROCEDURE. THE USER WAS CUT ON THE FOREHEAD. THERE WERE NO REPORTED DELAYS OR MEDICAL INTERVENTIONS.

  Patient problems: Device Embedded In Tissue or Plaque; Laceration(s)

  MAUDE report 13967851 ↗
• MalfunctionFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE DISASSEMBLED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579862 ↗
• MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DEVICE WAS MISSING COMPONENTS DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787061 ↗
• MalfunctionDec 15, 2020Fracture; Fracture

  THE DEVICE WAS MISSING PIECES DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11014871 ↗
• MalfunctionJan 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS FOUND TO HAVE PREVIOUSLY DISASSEMBLED WITH COMPONENTS MISSING DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9639028 ↗
• MalfunctionDec 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A PIECE MISSING WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9396427 ↗
• MalfunctionNov 18, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DEVICE HAD A PIECE BROKEN OFF DURING TESTING PRIOR TO A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 9335742 ↗
• MalfunctionJul 24, 2018Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. THERE WAS NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7714959 ↗