Fisher & Paykel Healthcare RT125Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09420012431141), received between Feb 16, 2017 and Apr 13, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K020332); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN CHINA, VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE RT125 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND BROKEN AFTER 10 MINUTES OF USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740533 ↗
• MalfunctionOct 31, 2022Leak/Splash; Leak/Splash

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN THAILAND VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE RT125 INFANT BIAS FLOW BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705167 ↗
• MalfunctionMay 31, 2022Crack

  A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN JAPAN THAT THE Y-PIECE OF A RT125 INFANT BIAS FLOW BREATHING CIRCUIT WAS FOUND CRACKED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14554516 ↗
• MalfunctionOct 11, 2017Crack; Crack

  A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE SWIVEL WYE OF THREE RT125 INFANT BIAS FLOW BREATHING CIRCUIT HAD A CRACK. THIS WAS FOUND WHEN THE CIRCUITS KITS WERE REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6943168 ↗
• MalfunctionApr 4, 2017Crack; Crack

  A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A CRACK WAS FOUND ON THE SWIVEL WYE OF AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT. THIS WAS DISCOVERED BEFORE PATIENT USE.

  Patient problems: No Patient Involvement

  MAUDE report 6459146 ↗
• MalfunctionFeb 16, 2017Leak/Splash; Leak/Splash

  A HOSPITAL IN (B)(4) REPORTED VIA A DISTRIBUTOR THAT THE RT125 INFANT BIAS FLOW BREATHING CIRCUIT DID NOT PASS THE INITIAL LEAK TEST OF THE VENTILATOR WHEN CHECKED BEFORE USE. THE MEDICAL ENGINEER NOTICED THE AIR LEAK WAS AT THE DUCK BILL. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6337754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020332. One submission often covers many models, so check the product and lot details in each record.

• Z-0553-05 · Dec 21, 2004 · Terminated
  RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.