Breathing circuit set, coaxial 260127Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630002802956), received between Mar 16, 2026 and Aug 6, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Obstruction of Flow

  Hamilton Medical AG received the following description:Quotation from the reporter: "On Friday evening, on (b)(6) 2026, the clinical team was preparing to transport a patient for diagnostic examinations using a Hamilton T1 transport ventilator when a previously observed problem recurred. The ventilator failed to ventilate the patient. The issue was detected at the patient's bedside, allowing the situation to be managed with only a minor decrease in oxygen saturation.A leak test and flow sensor test were performed again using the same breathing circuit. Both tests passed without any issues.The ventilator then began alarming for low tidal volume (VT), which was measured at only 70 mL. A volume-controlled ventilation mode was also tested; however, the ventilator was unable to achieve the desired tidal volume with a test lung. Although the tidal volume was set to 560 mL, only 440 mL was delivered, while the airway pressure increased to 33 cmH¿O." The same test was repeated using a new breathing circuit. However, the problem persisted.The patient was treated with another ventilator.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50156342 ↗
• MalfunctionJun 12, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: "ON (B)(6) 2026 THE HOSPITAL STAFF ASSEMBLED THE BREATHING CIRCUIT SET (PN 260127 / LN 211208), PERFORMED A PRE-USE CHECK, AND BEGAN USING IT ON THE PATIENT. HOWEVER, AN "EXHALATION OBSTRUCTED" ALARM OCCURRED AND COULD NOT BE RESOLVED, SO THE BREATHING CIRCUIT SET WAS REPLACED. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (REPLACEMENT OF THE BREATHING CIRCUIT SET) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25487222 ↗
• MalfunctionJun 12, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON MAY 7, 2026, MULTIPLE BREATHING CIRCUITS (PN 260127 / LN 203455; QTY: 6) PRESENTED WITH EXHALATION OBSTRUCTION / OCCLUSION ALARMS ON PATIENTS. PATIENT INVOLVEMENT WAS REPORTED WITH MEDICAL INTERVENTION (REPLACEMENT OF BREATHING CIRCUIT SETS) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486155 ↗
• MalfunctionJun 8, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE CUSTOMER HAS EXPERIENCED INTERMITTENT ISSUES WITH CERTAIN BREATHING CIRCUIT SETS (PN 260127 / LN 202096) USED IN THEIR CARDIO PULMONARY DEPARTMENT. CIRCUITS ASSOCIATED WITH THESE EVENTS WERE RETURNED TO THE BIOMEDICAL ENGINEERING (BIOMED) DEPARTMENT FOR EVALUATION. UPON TESTING, THE VENTILATORS PASSED FUNCTIONAL CHECKS; THEREFORE, THE CUSTOMER INITIATED TRACKING OF CIRCUIT LOT NUMBERS TO IDENTIFY ANY COMMON FACTORS. LOT NUMBER 202096 WAS IDENTIFIED AS THE COMMON FACTOR AMONG THE AFFECTED CIRCUITS. WHEN THESE CIRCUITS WERE EVALUATED, THE EXHALATION VALVE CONSISTENTLY GENERATED OBSTRUCTION ALERTS, A CONDITION THAT WAS REPRODUCED ON THREE SEPARATE VENTILATORS, WITH THE SAME ALERT OCCURRING EACH TIME, INDICATING A RECURRING ISSUE ASSOCIATED WITH THE CIRCUITS. PATIENT INVOLVEMENT WITH NO MEDICAL INTERVENTION AND NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428689 ↗
• MalfunctionJun 2, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON APRIL 27, 2026, THE HAMILTON-T1 VENTILATOR (PN 161006 / SN (B)(6) AND THE BREATHING CIRCUIT SET (PN 260127 / LN 203455) EXPERIENCED AN EXHALATION OBSTRUCTION ALARM. THE PATIENT WAS NOT HARMED. PATIENT INVOLVEMENT WAS REPORTED WITH MEDICAL INTERVENTION (REPLACEMENT OF THE EXHALATION VALVE) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD-PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25358877 ↗
• MalfunctionMar 18, 2026Obstruction of Flow

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "EXHALATION OBSTRUCTION" ALARMS, CLAIMS TAKES HIGH PRESSURE TO OPEN THE VALVE. NO ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625178 ↗
• MalfunctionMar 16, 2026Obstruction of Flow

  HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): HAMILTON MEDICAL AG RECEIVED A REPORT INVOLVING A HAMILTON-T1 VENTILATOR USED DURING PEDIATRIC VENTILATION. THE DEVICE WAS NEWLY PREPARED WITH COAXIAL TUBING AND TESTED WITHOUT ISSUES BEFORE PATIENT CONNECTION. AFTER THE CHILD WAS CONNECTED, THE VENTILATOR DELIVERED ONLY A FEW BREATHS BEFORE GENERATING AN ¿EXHALATION OBSTRUCTED¿ ALARM, RESULTING IN LOSS OF VENTILATION AND PATIENT DESATURATION. THE PATIENT WAS VENTILATED WITH AN ANAESTHESIA MACHINE WHILE A NEW BREATHING CIRCUIT WAS INSTALLED AND TESTED. AFTER RECONNECTION, THE SAME BEHAVIOR OCCURRED, AND VENTILATION WAS AGAIN LOST AFTER ONLY A FEW BREATHS. THE PATIENT WAS SUBSEQUENTLY MANUALLY VENTILATED DURING TRANSFER. THE ERROR OCCURRED DURING VENTILATION, VISUAL AND AUDIBLE ALARMS WERE ACTIVE. NO PERMANENT INJURY WAS REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: Insufficient Information; Low Oxygen Saturation

  MAUDE report 24603584 ↗