Breathing circuit set, coaxial 260128Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630002802963), received between Nov 20, 2024 and Sep 18, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (8 reports).

2 FDA recall records name this device's 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, 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 ↗

2. Jun 26, 2025Class IOpen, 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 problems

Recent adverse event reports

The 10 most recent of 10 reports, 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 ↗
• 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 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 ↗
• MalfunctionMay 29, 2026Obstruction of Flow

  IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: THE HAMILTON-T1 VENTILATOR (PN 161006 / SN 512288) AND THE BREATHING CIRCUIT SET (PN 260128 / LN UNKNOWN) EXPERIENCED INTERMITTENT "EXHALATION OBSTRUCTION" ALARM. NO PATIENT INVOLVEMENT, MEDICAL INTERVENTION OR PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329640 ↗
• MalfunctionNov 20, 2024Gas/Air Leak; Gas/Air Leak

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "CRACK IN BREATHING SET, TRANSVERSE TO A RIB. HOSE WAS TAKEN OUT OF THE PACKAGING WITH THE CRACK. HOSE STORED AS PER MANUFACTURER'S INSTRUCTIONS. THE CRACK WAS DISCOVERED DURING THE TEST. DURING THE PRE-OPERATIONAL CHECK. DELAYED DEPLOYMENT AS A SECOND BREATHING SET HAD TO BE ORGANISED (PLANNED RELOCATION)". NO HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733301 ↗