DAR 354/5876Recalls & reported problems
Covidien LP · Adult-Pediatric Mechanical Filter HME,Large · Class 1
Quick summary
This Covidien heat-and-moisture filter is used in breathing systems. The 25 reports mostly describe filters cracking or splitting before use, with no deaths or injuries; no recalls name this device. Reports rose from 3 in the previous 12 months to 22 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 20884521056753), received between Aug 14, 2025 and Mar 17, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Crack” (19 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
- Crack19
- Material Split, Cut or Torn6
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Crack
IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621626 ↗MalfunctionMar 17, 2026Crack
IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621588 ↗MalfunctionMar 17, 2026Crack
IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621562 ↗MalfunctionMar 17, 2026Crack
IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621514 ↗MalfunctionMar 17, 2026Crack
IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621471 ↗MalfunctionMar 17, 2026Crack
IT WAS REPORTED THAT DURING INSPECTION OF THE RECEIVED BREATHING SYSTEM FILTERS, SIX UNITS WERE FOUND CRACKED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621417 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723286 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723247 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723231 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723216 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723202 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723132 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723119 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723112 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723087 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723080 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723057 ↗MalfunctionDec 4, 2025Crack; Crack
IT WAS REPORTED THAT PRIOR TO USE, TWELVE DEVICES HAD CRACKS IN THE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723053 ↗MalfunctionNov 25, 2025Crack; Crack
IT WAS REPORTED THAT THE FILTER HAD A CRACK AT THE INTERFACE WHILE AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23649960 ↗MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE DEVICE "RUPTURED" AT THE INTERFACE PRIOR TO USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23623587 ↗MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE DEVICE "RUPTURED" AT THE INTERFACE PRIOR TO USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23623580 ↗MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE DEVICE "RUPTURED" AT THE INTERFACE PRIOR TO USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23623575 ↗MalfunctionAug 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PIPELINE OF THE FOUR DEVICES HAD A HOLE, TEAR AND SLIT DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22812258 ↗MalfunctionAug 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PIPELINE OF THE FOUR DEVICES HAD A HOLE, TEAR AND SLIT DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22812226 ↗MalfunctionAug 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PIPELINE OF THE FOUR DEVICES HAD A HOLE, TEAR AND SLIT DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22812221 ↗
Other CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) devices
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- DAR 353S19046Covidien LP · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)1 recall1 report
- HUDSON RCI IPN042781Teleflex Incorporated · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)1 recall1 report
- AVANOS 93816Avanos Medical, Inc. · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)24 reports
- HUDSON RCI IPN040673Teleflex Incorporated · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)11 reports
- Portex C45031682D-NLIcu Medical, Inc. · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)8 reports
- Portex 450952-NLIcu Medical, Inc. · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)8 reports
- HUDSON RCI IPN044386Teleflex Incorporated · CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.