Curaplex 5107ETRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810071631863), received between Mar 25, 2025 and Mar 28, 2025 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE SIXTH OF SIX REPORTS. REFER TO 1314417-2025-00017 FOR THE FIRST REPORT. REFER TO 1314417-2025-00018 FOR THE SECOND REPORT. REFER TO 1314417-2025-00019 FOR THE THIRD REPORT. REFER TO 1314417-2025-00020 FOR THE FOURTH REPORT. REFER TO 1314417-2025-00021 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE ZOLL MONITOR WAS APPLIED TO THE NON- INTUBATED PATIENT NO DATA DISPLAYED (NO READING AND/ OR RESPIRATORY RATE), WHICH LEAD TO A DELAY AND DIFFICULTY IN GATHERING VITAL SIGNS TO ASSESS BREATHING. THE CAPNO LINES WERE CHANGED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720240 ↗
• MalfunctionMar 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE FOURTH OF SIX REPORTS. REFER TO 1314417-2025-00017 FOR THE FIRST REPORT. REFER TO 1314417-2025-00018 FOR THE SECOND REPORT. REFER TO 1314417-2025-00019 FOR THE THIRD REPORT. REFER TO 1314417-2025-00021 FOR THE FIFTH REPORT. REFER TO 1314417-2025-00022 FOR THE SIXTH REPORT. IT WAS REPORTED, WHEN THE ZOLL MONITOR WAS APPLIED TO THE NON- INTUBATED PATIENT NO DATA DISPLAYED (NO READING AND/ OR RESPIRATORY RATE), WHICH LEAD TO A DELAY AND DIFFICULTY IN GATHERING VITAL SIGNS TO ASSESS BREATHING. THE CAPNO LINES WERE CHANGED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720233 ↗
• MalfunctionMar 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE FIFTH OF SIX REPORTS. REFER TO 1314417-2025-00017 FOR THE FIRST REPORT. REFER TO 1314417-2025-00018 FOR THE SECOND REPORT. REFER TO 1314417-2025-00019 FOR THE THIRD REPORT. REFER TO 1314417-2025-00020 FOR THE FOURTH REPORT. REFER TO 1314417-2025-00022 FOR THE SIXTH REPORT. IT WAS REPORTED, WHEN THE ZOLL MONITOR WAS APPLIED TO THE NON- INTUBATED PATIENT NO DATA DISPLAYED (NO READING AND/ OR RESPIRATORY RATE), WHICH LEAD TO A DELAY AND DIFFICULTY IN GATHERING VITAL SIGNS TO ASSESS BREATHING. THE CAPNO LINES WERE CHANGED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720227 ↗
• DeathMar 25, 2025Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  ETCO2 PLUGGED INTO MONITOR, ATTACHED TO A PATIENT, MONITOR (LP15) NOTED TO SPONTANEOUS XXX ETCO2 MODULE ON SCREEN. ETCO2 REPLACED AND REATTACHED TO SAME MONITOR - SAME RESULT. ADDITIONAL MONITOR OBTAINED, SECOND ETCO2 PROBE ATTACHED AND ATTACHED TO ETT - MONITOR SUCCESSFULLY DISPLAYED ETCO2 WITHOUT ISSUE. PATIENT PRONOUNCED DEAD AFTER FURTHER RESUSCITATION EFFORTS. OTHER: (B)(6). TWO SEPARATE DEVICES WERE USED IN RELATION TO THIS EVENT, THE FIRST REPORT NUMBER IS 1314417-2025-00015.

  Patient problems: Respiratory Failure

  MAUDE report 21693863 ↗
• MalfunctionMar 25, 2025Inaccurate Delivery; Inaccurate Information; Inaccurate Delivery; Inaccurate Information

  THE CUSTOMER REPORTED A "CLINICAL FAILURE" WITH THE ADULT/PED 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTOR DURING A PATIENT'S CARDIAC ARREST. WANTED TO CLARIFY WHICH INTUBATED CO2 DEVICE IS CAUSING ISSUES FOR THE CREWS. THESE DEVICES HAVE CAUSED A GREAT DEAL OF ISSUES INCLUDING CLINICAL FAILURES ON CARDIAC ARREST EVENTS. I HAVE EVEN HAD OUR MONITOR MANUFACTURER COME OUT AND SERVICE OUR DEVICES THINKING WE HAD AN ISSUE WITH A DEVICE. TO BE CLEAR, THESE ISSUES WE NOT JUST WITH THE CURAPLEX DEVICE BUT ALSO OTHER MANUFACTURER DEVICES. WE HAVE HAD A RUN OF CARDIAC ARRESTS OVER THE PAST MONTHS AND THIS HAS CAUSED A GREAT DEAL OF CONCERNS FROM THE CREWS. OTHER - CROSWELL EMS.

  Patient problems: Cardiac Arrest

  MAUDE report 21692072 ↗