VOCSN Patient Breathing Package Adult, Active, Heated, BlueRecalls & reported problems

Ventec Life Systems, Inc. · VOCSN Patient Breathing Package (Adult, Active, Heated, 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: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855573007921), received between Aug 15, 2025 and Aug 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Separation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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 ↗

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, Classified
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Z-1942-2026 · Mar 25, 2026 · Open, Classified
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Z-1196-2025 · Feb 3, 2025 · Open, Classified
VOCSN 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, Classified
VOCSN 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, Classified
Ventec 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

Device details

UDI-DI	`00855573007921`
Brand	VOCSN Patient Breathing Package
Model	Adult, Active, Heated, Blue
Catalog no.	PRT-00795-00X
Company	Ventec Life Systems, Inc.
Product code	NOU · Continuous, Ventilator, Home Use
Class	Class 2
FDA submission	K162877
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Dec 10, 2025

Device type (GMDN): In-exsufflator

A portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.

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All Continuous, Ventilator, Home Use devices →

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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