VOCSN Patient Breathing PackageRecalls & reported problems across all models

We found 5 models of VOCSN Patient Breathing Package by Ventec Life Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2023 and Oct 15, 2025 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (28 reports).

1 FDA recall record name at least one of these models by its device 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. 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

VOCSN Patient Breathing Package 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. Jan 9, 2024Class IOpen, Classified

   The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breathing circuit which may cause serious injury or death. The risk of injury or death is increased for ventilator dependent patients.

   Z-1070-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported VOCSN Patient Breathing Package problems

VOCSN Patient Breathing Package models

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

• VOCSN Patient Breathing Package Pediatric, Active, Oxygen, Blue

  Device, Positive Pressure Breathing, Intermittent
  1 recall25 reports
• VOCSN Patient Breathing Package Adult, Active, Heated, Oxygen, Blue

  Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  19 reports
• VOCSN Patient Breathing Package Adult, Passive, Oxygen, Blue

  Device, Positive Pressure Breathing, Intermittent
  3 reports
• VOCSN Patient Breathing Package Pediatric, Active, Heated, Oxygen, Blue

  Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  1 report
• VOCSN Patient Breathing Package Adult, Active, Heated, Blue

  Continuous, Ventilator, Home Use
  1 report

Recent VOCSN Patient Breathing Package adverse event reports

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

• MalfunctionOct 15, 2025Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT A PATIENT CIRCUIT (PEDIATRIC, ACTIVE, HEATED, BLUE) BROKE AT THE EXHALATION VALVE. THE REPORTER ALSO STATED THAT THE DEVICE HAD DISPLAYED A PATIENT CIRCUIT DISCONNECT ALARM, WHICH MAY HAVE BEEN DUE TO THE BROKEN CIRCUIT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287560 ↗
• MalfunctionAug 15, 2025Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT A PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, BLUE) HAD BROKEN DURING USE. THERE WAS PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. THE PATIENT WAS PLACED ON THEIR BACK UP VENTILATOR. THE REPORTER ADVISED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821755 ↗
• MalfunctionSep 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VENTEC THAT THE CLEAR FILM WALL OF A BREATHING CIRCUIT HAD DETACHED FROM THE BLUE POLYPROPYLENE SPIRAL PORTION OF THE PATIENT CIRCUIT (ADULT, PASSIVE, OXYGEN, BLUE) ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208342 ↗
• MalfunctionSep 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VENTEC THAT THE CLEAR FILM WALL OF A BREATHING CIRCUIT HAD DETACHED FROM THE BLUE POLYPROPYLENE SPIRAL PORTION OF THE PATIENT CIRCUIT (ADULT, PASSIVE, OXYGEN, BLUE) ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208038 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934640 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934578 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934478 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934212 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934134 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931528 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931342 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931314 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931109 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930893 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930626 ↗

Other Ventec Life Systems, Inc. products

• VOCSN17 models · 2,922 reports · 4 recalls
• HomeFill Oxygen System3 models · 0 reports · 3 recalls