DAR 4-076408-00Recalls & reported problems
Covidien LP · Neonatal D-X800 Expiratory Filter · Class 2
- 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 10884521087941), received between Apr 12, 2024 and Nov 14, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Use2
- Gas/Air Leak1
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.
MalfunctionNov 14, 2024Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, PRIOR TO USE, A LEAK WAS IDENTIFIED IN THE NEONATAL EXPIRATORY FILTER FOR THE RESPIRATOR AFTER ITS INSTALLATION. IN THIS SCENARIO, THE CIRCUIT AND BOARD WERE REPLACED AND THE FILTER LEAK STILL REMAINED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20692308 ↗MalfunctionApr 12, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
ACCORDING TO THE REPORTER, THE BREATHING SYSTEM'S FILTER CASE WAS DAMAGED BASED ON THE PHOTO PROVIDED. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND COMPONENT - DAMAGED/BROKEN/CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102127 ↗MalfunctionApr 12, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
ACCORDING TO THE REPORTER, THE BREATHING SYSTEM'S FILTER CASE WAS DAMAGED BASED ON THE PHOTO PROVIDED. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND COMPONENT - DAMAGED/BROKEN/CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102091 ↗
Other Filter, bacterial, breathing-circuit devices
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall570 reports
- VOCSN V+Pro Emergency, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit558 reports
- VOCSN V+O+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit3 recalls366 reports
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit2 recalls2 deaths325 reports
- VOCSN V+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit185 reports
- GIBECK IPN043751Teleflex Incorporated · Filter, bacterial, breathing-circuit2 recalls7 reports
- VOCSN VOCSN, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 death96 reports
- VOCSN V+C+Pro, JapaneseVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall33 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.