DAR 352/5877 (UDI 20884521719443)Recalls & reported problems
Covidien LP · Adult-Pediatric Electrostatic Filter HME, Small · Class 2
All models of DAR (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521719443), received between Jan 30, 2024 and May 14, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
- Mechanical Problem1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE FILTER'S CAP WAS TIGHT AND COULD NOT BE DETACHED. THERE WAS NO TIME TO REPLACE THE ARTIFICIAL NOSE, THEREFORE, WHEN ATTEMPTING TO FORCIBLY DETACH IT, THE PHYSICIAN BLED FROM HIS OWN FINGER.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unspecified Tissue Injury
MAUDE report 22016550 ↗MalfunctionMar 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT PRIOR TO USAGE, THE BREATHING SYSTEM'S FILTER HAD AN OUTFLOW OF THE ARTIFICIAL NOSE REGION. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21508823 ↗MalfunctionJan 30, 2024Mechanical Problem; Mechanical Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT PASS SST (SHORT SELF TEST). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607608 ↗
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- VOCSN VOCSN, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 death96 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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