N/A 1600HF-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607411101625), received between May 19, 2023 and Jun 12, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT RESIDENT WAS WEARING HIGH FLOW NASAL PRONG TUBING WHEN THEY NOTICED THE TUBING HAD BECOME DISCONNECTED NEAR THE NASAL PRONG CONNECTION PORT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25494235 ↗
• MalfunctionDec 5, 2025Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  IT WAS REPORTED THAT O2 TUBING FOUND TO HAVE A HOLE IN BETWEEN THE NASAL PRONGS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23735672 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED: ONE OF THE TUBES CONNECTED TO THE NASAL TIP BECAME DETACHED, RESULTING IN A SIGNIFICANT DROP IN THE AMOUNT OF OXYGEN DELIVERED TO THE PATIENT(S). THE ISSUE WAS RESOLVED BY REPLACING THE CANNULA(S). THE PATIENT(S) APPEARED TO HAVE SUFFERED NO LASTING EFFECTS; HOWEVER, SLIGHT HYPOXAEMIA WAS NOTED.

  Patient problems: Hypoxia

  MAUDE report 23563138 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED: ONE OF THE TUBES CONNECTED TO THE NASAL TIP BECAME DETACHED, RESULTING IN A SIGNIFICANT DROP IN THE AMOUNT OF OXYGEN DELIVERED TO THE PATIENT(S). THE ISSUE WAS RESOLVED BY REPLACING THE CANNULA(S). THE PATIENT(S) APPEARED TO HAVE SUFFERED NO LASTING EFFECTS; HOWEVER, SLIGHT HYPOXAEMIA WAS NOTED.

  Patient problems: Hypoxia

  MAUDE report 23563136 ↗
• MalfunctionMay 19, 2023Break; Break

  AN UPDATE FROM OUR CLINICAL TEAM ON A HOME VISIT WITH A PATIENT WHERE THE HIGH FLOW CANNULA HAS SPLIT AT THE CONNECTION WHERE THE CLEAR TUBING FEEDS IN THE GREEN SECTION. PATIENT NOTICED WHEN HE FELT THE OXYGEN WAS ESCAPING. NO PACKAGING TO SEE WHICH BATCH THIS WAS FROM.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16965644 ↗