VOCSN Patient Breathing Package Adult, Passive, Oxygen, BlueRecalls & reported problems
Ventec Life Systems, Inc. · VOCSN Patient Breathing Package (Adult, Passive, Oxygen, Blue) · Class 2
All models of VOCSN Patient Breathing Package (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00855573007044), received between Mar 12, 2024 and Sep 12, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).
5 other recalls cover devices cleared under the same FDA submission (K162877); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMar 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 PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18887817 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162877. One submission often covers many models, so check the product and lot details in each record.
- Z-2525-2026 · May 8, 2026 · Open, ClassifiedVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
- Z-1942-2026 · Mar 25, 2026 · Open, ClassifiedVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
- Z-1196-2025 · Feb 3, 2025 · Open, ClassifiedVOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
- Z-1070-2024 · Jan 9, 2024 · Open, ClassifiedVOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides c
- Z-1902-2021 · May 10, 2021 · Open, ClassifiedVentec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900
Other Device, Positive Pressure Breathing, Intermittent devices
- Percussionaire P5Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent4 recalls2 reports
- Volara System M08473Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT3 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls3 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Volara System M08085Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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