Breathing circuit set, coaxial 260167Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630002802970), received between Mar 11, 2026 and Apr 1, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 29, 2026Class IOpen, Classified

   Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement

   Z-2463-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Failure to Calibrate

  ACCORDING TO THE COMPLAINT DESCRIPTION THE ¿FLOW SENSOR CALIBRATION TEST FAILED MULTIPLE TIMES VIA HAMILTON MR1 SERIAL NUMBER (B)(6). DOCTOR CHANGED BREATHING SET PIPES A FEW TIMES. WHEN CHANGING THE HOSPITALS DEVICE FOR A MEDIDYNE LOANER BUT USING THE SAME BREATHING SET PIPES THAT WERE IN THE HOSPITAL, THE SAME FLOW SENSOR PROBLEM ALSO HAPPENED ON THE MEDIDYNE DEVICE.¿ ALTHOUGH PATIENT INVOLVEMENT WAS REPORTED, NO MEDICAL INTERVENTION, NO HEALTH CONSEQUENCES, AND NO IMPACT WERE REPORTED FOR THE PATIENT, THE USER, OR ANY THIRD PARTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754701 ↗
• MalfunctionMar 24, 2026Obstruction of Flow; Physical Resistance/Sticking

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT A VENTILATOR DISPLAYED RECURRING ¿EXHALATION OBSTRUCTED¿ ALARMS DURING PATIENT VENTILATION. THE DEVICE HAD PASSED THE TIGHTNESS TEST AND FLOW SENSOR CALIBRATION PRIOR TO USE, AND A NEW BREATHING SET WAS INSTALLED. THE ALARMS OCCURRED SHORTLY AFTER THE START OF VENTILATION AND INTERMITTENTLY DURING OPERATION ON TWO CONSECUTIVE DAYS. VENTILATION CONTINUED, AND NO PATIENT HARM WAS REPORTED, NO ADDITIONAL DEVICE REQUIRED REPORTED. THE CUSTOMER REQUESTED CLARIFICATION REGARDING THE ALARMS. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674335 ↗
• MalfunctionMar 11, 2026Increase in Pressure; Obstruction of Flow; Physical Resistance/Sticking

  HAMILTON MEDICAL AG RECEIVED A REPORT THAT A HAMILTON-T1 VENTILATOR STOPPED VENTILATION OR WAS UNABLE TO PROVIDE VENTILATION DURING A SURGICAL PROCEDURE. TESTING SHOWED THAT THE DIAPHRAGM OF THE EXPIRATORY VALVE OPENED ONLY AT APPROXIMATELY 20 MBAR, PREVENTING PROPER VENTILATION. A SECOND SIMILAR OCCURRENCE INVOLVING A BREATHING SET FROM A DIFFERENT LOT HAD PREVIOUSLY BEEN REPORTED. VENTILATION WAS SAFELY MAINTAINED USING AN ALTERNATIVE METHOD, AND NO HARM OR HEALTH IMPACT OCCURRED. THE AFFECTED BREATHING CIRCUIT (PRODUCT NUMBER 260167, LOT NUMBER 203019) WAS REPLACED WITH A NEW ONE. THE CASE WAS REPORTED BY THE HOSPITAL TO THE LOCAL AUTHORITY (SWISSMEDIC, REFERENCE (B)(4)). THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567789 ↗