Breathing circuit set, coaxial 260168Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630002802987), received between Mar 30, 2026 and Jun 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON 13TH MAY 2026 THE HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) AND BREATHING CIRCUIT SET (PN UNKNOWN / LOT UNKNOWN) PASSED PRE-USE CHECK, BUT WHEN CONNECTED TO THE PATIENT DISPLAYS "EXHALATION OBSTRUCTION" ALARM AND CANNOT VENTILATE. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (NATURAL OF MEDICAL INTERVENTION UNKNOWN) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25362053 ↗
• MalfunctionJun 2, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON 13TH MAY 2026 THE HAMILTON-T1 VENTILATOR (PN 1610060 / SN (B)(6) AND BREATHING CIRCUIT SET (PN UNKNOWN / LOT UNKNOWN) PASSED PRE-USE CHECK, BUT WHEN CONNECTED TO THE PATIENT DISPLAYS "EXHALATION OBSTRUCTION" ALARM AND CANNOT VENTILATE. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (NATURAL OF MEDICAL INTERVENTION UNKNOWN) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360342 ↗
• MalfunctionJun 2, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON (B)(6) 2026 THE HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) AND BREATHING CIRCUIT SET (PN UNKNOWN / LOT UNKNOWN) PASSED PRE-USE CHECK, BUT WHEN CONNECTED TO THE PATIENT DISPLAYS "EXHALATION OBSTRUCTION" ALARM AND CANNOT VENTILATE. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (NATURAL OF MEDICAL INTERVENTION UNKNOWN) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359469 ↗
• MalfunctionMar 30, 2026Obstruction of Flow; Physical Resistance/Sticking

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "VENTILATOR PASSED PRE-OP CHECKS, PUT ON PATIENT...ALARM EVIDENT "EXHALATION OBSTRUCTION - LOW MINUTE VOLUME". STAFF CHANGED PATIENT TO DIFFERENT VENT (DRAGER V800)...PATIENT VENTILATED OK. RETRIEVED SPARE T1 VENTILATOR, PASSED PRE-OP, TRANSFERRED PATIENT TO THIS T1 OK. STAFF CHECKED FIRST T1 (27551) AGAIN, PUT ON A TEST LUNG...INITIALLY DIDN'T VENTILATE PROPERLY BUT RESOLVED AFTER 5 MINUTES AND VENTILATED OK." NO HEALTH CONSEQUENCES OR IMPACT. THE CASE HAS NOT BEEN REVIEWED YET BY HAMILTON MEDICAL AG. THEREFORE THE FAILURE DESCRIPTION COULD NOT BE CONFIRMED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728855 ↗