CORE 5400037000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04546540401960), received between Jul 24, 2018 and Sep 26, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2023Overheating of Device; Overheating of Device

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816868 ↗
• MalfunctionSep 11, 2023Overheating of Device; Overheating of Device

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726300 ↗
• MalfunctionJan 3, 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 16090160 ↗
• MalfunctionJul 27, 2022Overheating 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 15113624 ↗
• MalfunctionJun 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  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 Patient Involvement

  MAUDE report 10116057 ↗
• MalfunctionMay 11, 2020Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE UNINTENTIONALLY ACTIVATED 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 10043307 ↗
• MalfunctionMar 17, 2020Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 9842785 ↗
• MalfunctionJan 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A COMPONENT 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 9596206 ↗
• MalfunctionDec 17, 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 Patient Involvement

  MAUDE report 9484464 ↗
• MalfunctionSep 19, 2019Overheating 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 9087078 ↗
• MalfunctionJul 9, 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 Patient Involvement

  MAUDE report 8773173 ↗
• MalfunctionJun 11, 2019Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 8688340 ↗
• MalfunctionMar 11, 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 Patient Involvement

  MAUDE report 8409473 ↗
• MalfunctionFeb 19, 2019Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 8352576 ↗
• MalfunctionNov 26, 2018Unintended Power Up; Unintended Power Up

  THE DEVICE RAN ON IT'S OWN WITHOUT ACTIVATION DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY.  THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8102682 ↗
• MalfunctionNov 7, 2018Overheating 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 Patient Involvement

  MAUDE report 8047957 ↗
• MalfunctionOct 29, 2018Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015063 ↗
• MalfunctionOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8014644 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. FOUR (4) EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715288 ↗
• MalfunctionJul 24, 2018Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. TWO EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715276 ↗
• MalfunctionJul 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. ONE EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715240 ↗
• MalfunctionJul 24, 2018Unintended Power Up; Unintended Power Up

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. ONE EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7714921 ↗