VOCSN Patient Breathing Package Pediatric, Active, Oxygen, BlueRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00855573007587), received between Dec 7, 2023 and Mar 12, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (25 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 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.

Recalls naming this device

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 problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890681 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890666 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890641 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890611 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890534 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890310 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889278 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889245 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889073 ↗
• MalfunctionMar 12, 2024Material Integrity Problem; Material Integrity Problem

  VENTEC CONTACTED THE CUSTOMER TO ENSURE THE RECEIPT AND ACKNOWLEDGEMENT OF CUSTOMER RECALL NOTIFICATION Z-1070-2024 FOR THE VOCSN PATIENT BREATHING PACKAGE (PEDIATRIC, ACTIVE, OXYGEN, BLUE). THE CUSTOMER VERBALLY CONFIRMED RECEIPT OF THE CUSTOMER RECALL NOTIFICATION. DURING THAT CONVERSATION, THE CUSTOMER NOTIFIED VENTEC THAT THE PATIENT CIRCUIT HAD BEEN FOUND TO BE DEFECTIVE RIGHT OUT OF THE BOX, NOTING THAT THE BREATHING CIRCUIT PRODUCT COIL STRUCTURE HAD BECOME DELAMINATED FROM THE CIRCUIT TUBING. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889038 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288876 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288859 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288799 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288791 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288775 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288744 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288739 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288738 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288736 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288707 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288648 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288621 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288615 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288567 ↗
• MalfunctionDec 7, 2023Material 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 (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THE REPORTED ISSUE WAS DISCOVERED DURING INCOMING INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. SECTION D4 MODEL NUMBER, CATALOG NUMBER AND LOT CODE REFLECTS THE INFORMATION KNOWN ABOUT THE PATIENT CIRCUIT. THE UDI WAS UNAVAILABLE AT THE TIME OF THIS SUBMISSION, THEREFORE SECTION D4 UDI IS "UNKNOWN", AND SECTION H4 DATE OF MANUFACTURER WILL BE LEFT BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288548 ↗

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-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