Curaplex 5707F-SERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810071631696), received between Jan 22, 2025 and May 15, 2025 — classified as 1 death, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED, THE TUBE THAT GOES INTO THE GAS BENCH FROM THE CONNECTOR BROKE OFF AND CREATED AN UNSPECIFIED LIFE-THREATENING INJURY TO THE PATIENT. THE MONITOR WAS CHANGED; NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 22031560 ↗
• 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 SECOND OF SIX REPORTS. REFER TO 1314417-2025-00017 FOR THE FIRST 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. REFER TO 1314417-2025-00022 FOR THE SIXTH REPORT. IT WAS REPORTED, WHEN THE ZOLL MONITOR WAS APPLIED TO THE 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 21720239 ↗
• 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 THIRD OF SIX REPORTS. REFER TO 1314417-2025-00017 FOR THE FIRST REPORT. REFER TO 1314417-2025-00018 FOR THE SECOND REPORT. REFER TO 1314417-2025-00020 FOR THE FOURTH 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 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 21720224 ↗
• 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 FIRST OF SIX REPORTS. 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. REFER TO 1314417-2025-00022 FOR THE SIXTH REPORT. IT WAS REPORTED, WHEN THE ZOLL MONITOR WAS APPLIED TO THE 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 21720223 ↗
• 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 SECOND REPORT NUMBER IS 1314417-2025-00016.

  Patient problems: Respiratory Failure

  MAUDE report 21693862 ↗
• MalfunctionJan 22, 2025Disconnection; Disconnection

  THE NASAL CANNULA CONNECTION TO THE REGULATOR BECAME DISCONNECTED FROM THE FLARE FITTING PORTION OF THE O2 REGULATOR WHILE IN USE. IT WAS REPORTED FOR 3 DIFFERENT INCIDENTS FOR THE SAME DEVICE. THIS IS THE SECOND OF 3 REPORTS FOR THIS COMPLAINT. REFERENCE 1314417-2025-00002 FOR 1ST INCIDENT AND 1314417-2025-00004 FOR THE 3RD INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213491 ↗
• MalfunctionJan 22, 2025Disconnection; Disconnection

  THE NASAL CANNULA CONNECTION TO THE REGULATOR BECAME DISCONNECTED FROM THE FLARE FITTING PORTION OF THE O2 REGULATOR WHILE IN USE. IT WAS REPORTED FOR 3 DIFFERENT INCIDENTS FOR THE SAME DEVICE. THIS IS THE THIRD OF 3 REPORTS FOR THIS COMPLAINT. REFERENCE 1314417-2025-00002 FOR 1ST INCIDENT AND 1314417-2025-00003 FOR THE 2ND INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213429 ↗
• MalfunctionJan 22, 2025Disconnection; Disconnection

  THE NASAL CANNULA CONNECTION TO THE REGULATOR BECAME DISCONNECTED FROM THE FLARE FITTING PORTION OF THE O2 REGULATOR WHILE IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212165 ↗