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N/A 2026035Recalls & reported problems

Intersurgical Incorporated · 22MM SINGLE HEATED WIRE BREATHING SYSTEM · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05030267140343), received between Jul 27, 2018 and Jul 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Displays Incorrect Message1
  • Material Split, Cut or Torn1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryJul 27, 2018Device Displays Incorrect Message; Material Split, Cut or Torn

    THE A SINGLE LIMB HEATED CIRCUIT WAS USED ON A HOME CARE VENTILATOR AND ALARMED. IT WAS OBSERVED THAT THE TUBING HAD HOLE IN IT. THERE WAS NO PATIENT HARM AND THE CIRCUIT WAS REPLACED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7728408 ↗

Other Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer devices

All Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.