Breathing circuit set, coaxialRecalls & reported problems across all models

We found 4 models of Breathing circuit set, coaxial by Hamilton Medical AG in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2024 and Sep 18, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (21 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Breathing circuit set, coaxial recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 29, 2026Open, 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 · names 4 of these models · Recall details · FDA record ↗

2. Jun 26, 2025Open, Classified

   Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.

   Z-2167-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported Breathing circuit set, coaxial problems

Breathing circuit set, coaxial models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Breathing circuit set, coaxial 260128

  Set, Tubing And Support, Ventilator (W Harness)
  2 recalls10 reports
• Breathing circuit set, coaxial 260127

  Set, Tubing And Support, Ventilator (W Harness)
  1 recall7 reports
• Breathing circuit set, coaxial 260168

  Set, Tubing And Support, Ventilator (W Harness)
  1 recall4 reports
• Breathing circuit set, coaxial 260167

  Set, Tubing And Support, Ventilator (W Harness)
  1 recall3 reports

Recent Breathing circuit set, coaxial adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Obstruction of Flow

  It was reported to Hamilton Medical AG, that: "Time of incident around 1800hrs, out of hospital cardiac arrest, intubated patient in emergency department. Once connected patient to ventilator, "Exhalation Obstruction" alarm was noted. No harm to patient. Unable to definitively state actual batch of Hamilton circuit used as the packaging was accidently discarded."Patient involvement with medical intervention in the form of the patient being disconnected from the ventilator and placed on BVM, while the ventilator circuit was replaced, was reported. No patient, user or third party harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50815023 ↗
• MalfunctionSep 18, 2026Obstruction of Flow

  It was reported to Hamilton Medical AG, that: "Overnight we had an issue with 2 of our Hamilton ventilators when attempting to ventilate an intubated patient. The patient bagged well and was reviewed by anaesthetics to assess the ETT, there were no identifiable issues with the tube or patient in terms of obstruction. Multiple alarms displaying were "Exhalation obstruction" "High PEEP" "Expiratory flow low"."The customer noted that they could not troubleshoot the alarms. They tried two ventilators (SN: (b)(6) & SN: (b)(6) on two different circuits (both part 260128) with no success. Logs show that there are multiple instances of the following alarms: Disconnection on patient side, Exhalation obstructed & High PEEP on SN (b)(6) .Patient involvement with medical intervention in the form of the patient being bagged and assessment of the ETT was reported. However, no patient, user or third party harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814430 ↗
• MalfunctionSep 17, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804697 ↗
• MalfunctionAug 26, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451052 ↗
• 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 18, 2026Gas/Air Leak

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: "AS PER THE DOCTORS REPORT: "THE ALARM WAS OF "LOW MINUTE/TIDAL VOLUME" (TV ~60MLS), DESPITE GOOD DRIVING PRESSURE. I OBSERVED FOR ABOUT 3-4 BREATHS THERE WAS NO IMPROVEMENT AND SO I WENT BACK ONTO THE BEDSIDE VENT. FROM WHAT I CAN REMEMBER THERE WAS NOT A SPECIFIC "EXHALATION OBSTRUCTED" ALARM. WE TRIED AGAIN, AND THE SAME THINGS HAPPENED. I THEN CHANGED THE EXPIRATORY FILTER, AND ON TRANSFERRING TO THE HAMILTON FOR THE 3RD TIME THERE WERE NO ISSUES" PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION, BUT NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548958 ↗
• MalfunctionJun 18, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE CUSTOMER HAD A BREATHING CIRCUIT SET (PN 260128 / LN 201529) ISSUE WHERE A PATIENT WAS VENTILATED APPROPRIATELY FOR THE MAJORITY OF THEIR TRIP, AND THEN A "EXPIRATORY OCCLUSION" ALARM OCCURRED. THE PATIENT HAD TO BE BAGGED FOR A FEW MINUTES BEFORE GETTING TO THE HOSPITAL. NO PATIENT HARM OR CHANGE IN VITALS. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (BAGGING), BUT WITHOUT PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545613 ↗
• 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 8, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON (B)(6) 2026 THE HOSPITAL STAFF ASSEMBLED THE BREATHING CIRCUIT SET (PN 260128 / LN UNKNOWN) WITH A HAMILTON-T1 (PN 161006 / SN (B)(6), PERFORMED A PRE-USE CHECK, AND BEGAN USING IT ON A PATIENT. HOWEVER, AN "EXPIRATORY OBSTRUCTION" ALARM OCCURRED AND COULD NOT BE RESOLVED, SO THE ENTIRE VENTILATOR WAS REPLACED. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (REPLACEMENT OF THE ENTIRE VENTILATOR) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428108 ↗
• MalfunctionJun 8, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: ON APRIL 28TH, 2026 THE HOSPITAL STAFF ASSEMBLED THE BREATHING CIRCUIT SET (PN 260128 / LN UNKNOWN) WITH A HAMILTON-T1 (SN (B)(6), PERFORMED A PRE-USE CHECK, AND BEGAN USING IT ON A PATIENT. HOWEVER, AN "EXPIRATORY OBSTRUCTION" ALARM OCCURRED AND COULD NOT BE RESOLVED, SO THE ENTIRE VENTILATOR WAS REPLACED. PATIENT INVOLVEMENT WITH MEDICAL INTERVENTION (REPLACEMENT OF THE ENTIRE VENTILATOR) WAS REPORTED. HOWEVER, NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426724 ↗
• 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 ↗

Other Hamilton Medical AG products

• HAMILTON-C12 models · 2,012 reports · 2 recalls
• HAMILTON-G52 models · 1,891 reports
• HAMILTON-T15 models · 1,185 reports · 3 recalls
• HAMILTON-C22 models · 853 reports · 1 recall
• HAMILTON-MR12 models · 151 reports · 2 recalls