VOCSNRecalls & reported problems across all models

We found 17 models of VOCSN by Ventec Life Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 2,922 adverse event reports in the FDA's MAUDE database, received between Apr 16, 2018 and Sep 30, 2026 — classified as 7 deaths, 81 injuries, 2,834 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2,121 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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 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 8, 2026Open, Classified

   Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

   Z-2525-2026 · Root cause: Vendor change control · Recall details · FDA record ↗

2. Mar 25, 2026Open, Classified

   Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

   Z-1942-2026 · Root cause: Process change control · Recall details · FDA record ↗

3. Feb 3, 2025Open, Classified

   Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

   Z-1196-2025 · Root cause: Component change control · names 3 of these models · Recall details · FDA record ↗

4. May 10, 2021Open, Classified

   Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.

   Z-1902-2021 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗

Most reported VOCSN problems

VOCSN models

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

• VOCSN V+Pro, English

  Filter, Bacterial, Breathing-Circuit
  1 recall570 reports
• VOCSN V+Pro Emergency, English

  Filter, Bacterial, Breathing-Circuit
  558 reports
• VOCSN V+O+C+S+N+Pro, English

  Filter, Bacterial, Breathing-Circuit
  3 recalls366 reports
• VOCSN V+Pro, English

  Filter, Bacterial, Breathing-Circuit
  2 recalls2 deaths325 reports
• VOCSN V+O+C+S+N, English

  Ventilator, Continuous, Facility Use
  1 recall286 reports
• VOCSN V*Home, English

  Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
  4 deaths318 reports
• VOCSN V+C+S+N+Pro, English

  Filter, Bacterial, Breathing-Circuit
  185 reports
• VOCSN VOCSN, English

  Filter, Bacterial, Breathing-Circuit
  1 death96 reports
• VOCSN V+C+Pro, Japanese

  Filter, Bacterial, Breathing-Circuit
  1 recall33 reports
• VOCSN V+O+C+S+N+Pro, Japanese

  Filter, Bacterial, Breathing-Circuit
  1 recall32 reports
• VOCSN V+C, English

  Ventilator, Continuous, Facility Use
  1 recall27 reports
• VOCSN V+C+Pro, English

  Filter, Bacterial, Breathing-Circuit
  1 recall25 reports
• VOCSN V+C+Pro, Japanese

  Filter, Bacterial, Breathing-Circuit
  41 reports
• VOCSN V+C, Japanese

  Ventilator, Continuous, Facility Use
  30 reports
• VOCSN V+O+C+S+N, Japanese

  Ventilator, Continuous, Facility Use
  14 reports
• VOCSN V+Pro, English

  Filter, Bacterial, Breathing-Circuit
  11 reports
• VOCSN V+O+C+S+N+Pro, Japanese

  Filter, Bacterial, Breathing-Circuit
  5 reports

Recent VOCSN adverse event reports

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

• InjurySep 30, 2026Output Problem

  Patient problems: Low Oxygen Saturation

  MAUDE report 50952873 ↗
• InjurySep 29, 2026Use of Device Problem

  Patient problems: Discomfort

  MAUDE report 50941194 ↗
• InjurySep 29, 2026Use of Device Problem

  Patient problems: Discomfort

  MAUDE report 50941181 ↗
• MalfunctionSep 28, 2026Output Problem

  An authorized service provider (ASP) contacted Ventec to report that the device was delivering higher than set PEEP (Positive End Expiratory Pressure).There were no reports of patient involvement associated with the reported issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917801 ↗
• MalfunctionSep 27, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910491 ↗
• MalfunctionSep 27, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910489 ↗
• MalfunctionSep 24, 2026Unexpected Shutdown

  It was reported that the device needed service. Upon receipt of the device, Ventec downloaded its electronic records (System Logs) for analysis and observed that the device had previously powered off by itself.There was patient involvement associated with the reported event; however, there was no patient harm as a result of the reported issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885555 ↗
• MalfunctionSep 3, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598680 ↗
• MalfunctionJun 30, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DISPLAYING THE PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673982 ↗
• MalfunctionJun 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE LCD TOUCHSCREEN ON THE DEVICE WAS UNRESPONSIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673945 ↗
• MalfunctionJun 30, 2026Display or Visual Feedback Problem

  AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE'S LCD TOUCHSCREEN WAS UNRESPONSIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673924 ↗
• MalfunctionJun 30, 2026Use of Device Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE HAD DISPLAYED THE PATIENT CIRCUIT DISCONNECT ALARM. 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 25673879 ↗
• MalfunctionJun 30, 2026Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOW INSPIRATORY PRESSURE AND LOW VTE (EXHALED TIDAL VOLUME) LEVELS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673746 ↗
• MalfunctionJun 29, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661743 ↗
• MalfunctionJun 25, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS REBOOTING BY ITSELF. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25631451 ↗

Other Ventec Life Systems, Inc. products

• HomeFill Oxygen System3 models · 0 reports · 3 recalls
• VOCSN Patient Breathing Package5 models · 49 reports · 1 recall