CORE 5400031000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04546540401946), received between Jul 24, 2018 and Aug 6, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 6, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE WAS SLOW BRAKING DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19922453 ↗
• MalfunctionJul 13, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316716 ↗
• MalfunctionMar 9, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515860 ↗
• MalfunctionFeb 15, 2022Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 13538573 ↗
• MalfunctionDec 6, 2021Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 12939774 ↗
• MalfunctionJul 9, 2021Device Remains Activated; Device Remains Activated

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN ON 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 12143221 ↗
• MalfunctionOct 29, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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 10754909 ↗
• MalfunctionSep 22, 2019Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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; No Patient Involvement

  MAUDE report 9101796 ↗
• MalfunctionApr 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Patient Involvement

  MAUDE report 8514609 ↗
• MalfunctionFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Patient Involvement

  MAUDE report 8315351 ↗
• MalfunctionJan 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE HEAD WAS 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 8232002 ↗
• MalfunctionDec 6, 2018Overheating of Device; Overheating of Device

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

  Patient problems: No Patient Involvement

  MAUDE report 8137719 ↗
• MalfunctionDec 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Patient Involvement

  MAUDE report 8126017 ↗
• MalfunctionNov 15, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Patient Involvement

  MAUDE report 8073504 ↗
• MalfunctionNov 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DEVICE WAS DISASSEMBLED 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 8043826 ↗
• MalfunctionNov 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT THE DEVICE WAS LEAKING A BROWN RESIDUE 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 8028224 ↗
• MalfunctionOct 29, 2018Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015059 ↗
• MalfunctionOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 6 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015056 ↗
• MalfunctionOct 29, 2018Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015055 ↗
• MalfunctionOct 29, 2018Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. 1 EVENT HAD NO INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8014648 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. TEN (10) EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7714918 ↗