CORE 5400099000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04546540401977), received between Jul 24, 2018 and Dec 8, 2021 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Unintended Power Up” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2021Fail-Safe Problem; Fail-Safe Problem

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS NOT STAYING IN SAFE 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 12964562 ↗
• MalfunctionOct 15, 2021Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12639020 ↗
• MalfunctionApr 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT THE DEVICE WAS LEAKING 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 11648025 ↗
• MalfunctionSep 11, 2020Unintended Power Up; Unintended Power Up

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

  Patient problems: No Patient Involvement

  MAUDE report 10521363 ↗
• MalfunctionJul 22, 2019Device Remains Activated; Device Remains Activated

  THE USER FACILITY REPORTED THAT THE DEVICE HAD RUN ON 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 8812924 ↗
• MalfunctionApr 15, 2019Fail-Safe Problem; Fail-Safe Problem

  THE USER FACILITY REPORTED THAT THE DEVICE RAN IN SAFE MODE 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 8515807 ↗
• MalfunctionMar 18, 2019Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE WAS RUNNING ON ITS OWN 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 8428053 ↗
• MalfunctionDec 18, 2018Device Remains Activated; Device Remains Activated

  THE USER FACILITY REPORTED THAT THE DEVICE WAS NOT STOPPING AFTER TRIGGER WAS RELEASED 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 8175844 ↗
• MalfunctionDec 12, 2018Unintended Power Up; Unintended Power Up

  THE USER FACILITY REPORTED THAT THE DEVICE RUNS ON ITS OWN 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 8156857 ↗
• MalfunctionNov 12, 2018Unintended Power Up; Unintended Power Up

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

  Patient problems: No Patient Involvement

  MAUDE report 8061546 ↗
• MalfunctionOct 29, 2018Unintended Power Up; Positioning Problem; Unintended Power Up; Positioning Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015081 ↗
• MalfunctionOct 29, 2018Fail-Safe Problem; Fail-Safe Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015068 ↗
• 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 Patient Involvement

  MAUDE report 8014643 ↗
• MalfunctionOct 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD NO INFORMATION RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 8014243 ↗
• MalfunctionJul 24, 2018Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. THE 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7715289 ↗
• MalfunctionJul 24, 2018Device Remains Activated; Physical Resistance/Sticking; Device Remains Activated; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE TRIGGER WAS STICKING LEADING TO RUN-ON; THERE WAS NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715282 ↗
• 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 Patient Involvement

  MAUDE report 7715274 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715263 ↗
• MalfunctionJul 24, 2018Fail-Safe Problem; Fail-Safe Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION; 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7715243 ↗
• MalfunctionJul 24, 2018Unintended Power Up; Unintended Power Up

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714924 ↗