Curaplex 2113-10275Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817617022512), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 death.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathFeb 23, 2022Break; Material Puncture/Hole; Break; Material Puncture/Hole

  DURING INTUBATION OF PT, AIR LEAK IN ET TUBES. CODE WAS CALLED AND PT EXPIRED. DATE OF SERVICE: (B)(6) 2022. WAS A PATIENT WHO HAS BEEN IN OUR FACILITY SINCE (B)(6) 2022 WITH COVID-19. THE PATIENT HAD BEEN ON OUR TYPICAL REGIMEN FOR THIS, INCLUDING STEROIDS, OLUMIANT, AND VEKLURY. THE PATIENT HAD FINISHED A COURSE OF VEKLURY AND WAS CONTINUING TO GET STEROIDS. THE PATIENT HAD WORSENING RESPIRATORY STATUS OVER THE LAST TWO DAYS. I SPOKE TO THE PATIENT ON (B)(6) 2022. THE PATIENT DECLINED TO BE INTUBATED AT THAT TIME. HE STATED THAT HE FELT LIKE HE COULD KEEP HIS SATURATIONS AND HE UNDERSTOOD THE RISKS OF WAITING. THROUGHOUT THE NIGHT LAST NIGHT, UP INTO THE MORNING OF (B)(6) 2022, THE PATIENT HAD SOME TIMES WHERE HIS SATURATIONS DROPPED TO THE UPPER 80'S. AT THE TIME I SPOKE TO HIM, THE PATIENT WAS SATURATING BETWEEN 88%-90%. HE STATED THAT HE DID FEEL SOME BETTER BUT THAT IF THINGS WORSENED THEN HE WOULD UP FOR INTUBATION. APPROXIMATELY 2-3 HOURS AFTER I HAD SEEN HIM, HE DEVELOPED INCREASING WORK OF BREATHING AND ASKED THE NURSE TO CALL ME AND TELL ME THAT HE WAS WILLING TO BE INTUBATED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS NOTICEABLY MORE SHORT O

  Patient problems: Respiratory Failure

  MAUDE report 13677981 ↗