N/A 1053-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607411101113), received between May 12, 2023 and Mar 14, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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.

• MalfunctionMar 14, 2025Blocked Connection; Connection Problem; Blocked Connection; Connection Problem

  IT WAS REPORTED THAT DURING PATIENT USE, THE NASAL CANNULA WAS OBSTRUCTED AT THE CONNECTION BETWEEN THE TUBING AND NASAL PRONGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612810 ↗
• MalfunctionMay 15, 2024Disconnection; Disconnection

  IT WAS REPORTED, THE PATIENT'S TUBE [WHICH WAS] CONNECTED TO THE NASAL TIPS CAME OFF AFTER A COUPLE OF DAYS. THE DEVICE WAS IN USE AT THE PATIENT'S HOME; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326267 ↗
• MalfunctionMar 20, 2024Material Integrity Problem; Material Integrity Problem

  THE EYEGLASS TUBE IS COMING LOOSE OR DOES NOT FIT AT THE JOINT BETWEEN THE TUBE AND THE NASAL PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946341 ↗
• MalfunctionMar 15, 2024Break; Break

  THE GLASSES HAVE A DEFECT AT THE JOINT BETWEEN THE NASAL PART AND THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918179 ↗
• InjuryMar 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ABUNDANT EPISTAXIS, BREAKING OF NASAL CAPILLARIES.

  Patient problems: Bruise/Contusion

  MAUDE report 18842480 ↗
• InjuryMar 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  "NASAL CRUSTING AND BLEEDING, EVOLVING INTO PAIN IN THE NASAL MUCOSA FOLLOWING OXYGEN INTAKE. ALSO REFER TO: FEELING OF HARDNESS AND LACK OF ADHESION OF THE CANNULAE TO THE NASAL MUCOSA DURING OXYGEN INTAKE. DEVELOPED INTOLERANCE TO THE NASAL CANNULAE NORMALLY USED OVER TIME (CANNOT SAY FOR HOW LONG). PROBLEM IMPROVED WITH THE USE OF SOFT CANNULAE. AT THE SAME TIME THE PHARMACOVIGILANCE REPORT RELATING TO MEDICAL OXYGEN HAS ALSO BEEN SENT."

  Patient problems: Bruise/Contusion

  MAUDE report 18842479 ↗
• MalfunctionAug 11, 2023Connection Problem; Connection Problem

  NASAL PRONGS COME OFF & POSSIBILITY OF LOSS OF O2 DURING USE.

  Patient problems: Hypoxia

  MAUDE report 17512117 ↗
• MalfunctionMay 12, 2023Material Integrity Problem; Material Integrity Problem

  DEFECTED BONDED BETWEEN THE GLASSES AND THE TUBING.

  Patient problems: Hypoxia

  MAUDE report 16918957 ↗