Fisher & Paykel Healthcare ICONPBN-HTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09420012425034), received between Mar 1, 2018 and Jun 26, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Mechanical Problem; Mechanical Problem

  A DISTRIBUTOR IN CANADA, REPORTED THAT THE POWER CORD OF AN ICON CPAP HUMIDIFIER HAS BEEN DAMAGED WITH COPPER WIRES EXPOSED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342968 ↗
• MalfunctionNov 20, 2024Mechanical Problem; Mechanical Problem

  A DISTRIBUTOR IN CANADA, REPORTED THAT THE POWER CORD OF AN ICON CPAP HUMIDIFIER HAS CRACKED WITH EXPOSED COPPER WIRES. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20741663 ↗
• MalfunctionFeb 12, 2023Mechanical Problem; Mechanical Problem

  A DISTRIBUTOR IN CANADA, REPORTED THAT THE POWER CORD OF AN ICON CPAP HUMIDIFIER HAD BEEN DAMAGED WITH EXPOSED COPPER WIRES. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359904 ↗
• MalfunctionMay 20, 2021Material Frayed; Mechanical Problem; Mechanical Problem

  A DISTRIBUTOR IN CANADA REPORTED THAT AN ICON AUTO CPAP HUMIDIFIER POWER CORD WAS FRAYED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860969 ↗
• MalfunctionSep 10, 2020Break; Mechanical Problem; Mechanical Problem

  A HEALTHCARE FACILITY IN CANADA REPORTED THAT AN ICON CPAP HUMIDIFIER HAD A BROKEN POWER CORD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10519225 ↗
• MalfunctionMar 18, 2020Mechanical Problem; Mechanical Problem

  A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN ICON CPAP HUMIDIFIER HAD A FRAYED POWER CORD. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9850385 ↗
• MalfunctionMar 1, 2018Device Issue; Moisture or Humidity Problem; Device Issue; Moisture or Humidity Problem

  A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE ICON+ PREMO CPAP HUMIDIFIER HAD CONDENSATION ISSUES. IT WAS ALSO REPORTED THAT THE PATIENT WAS ALLEGING THAT THE CONDENSATE WENT INTO HER LUNGS. THE INCIDENT OCCURRED SIX WEEKS AFTER THE PATIENT WAS SET UP ON ICON HUMIDIFIER. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7308269 ↗