Filter 6221Recalls & reported problems
Westmed, Inc. · Inline Maxi HME Filter, W/Sampling Port (7-5877) · 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 00709078000959), received between Mar 26, 2021 and May 30, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2024Material Fragmentation; Material Integrity Problem; Material Fragmentation; Material Integrity Problem
PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: ONE OF THE REINFORCED STAPLE LOADS REINFORCEMENT WAS NOT ATTACHED AND FLOPPING ALL AROUND. IT WOULDN'T SIT WELL WHEN ATTEMPTED TO USE BY NOT LINING UP CORRECTLY ON STAPLE LOAD SO IT WASN'T USED. REMOVED FROM FIELD AND ANOTHER ONE WAS OPENED AND USED INSTEAD. REMOVED FROM FIELD AND GIVEN TO MANAGEMENT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19431147 ↗MalfunctionApr 30, 2024
ONE OF THE REINFORCED STAPLE LOADS REINFORCEMENT WAS NOT ATTACHED AND FLOPPING ALL AROUND. IT WOULDN'T SIT WELL WHEN ATTEMPTED TO USE BY NOT LINING UP CORRECTLY ON STAPLE LOAD SO IT WASN'T USED. REMOVED FROM FIELD AND ANOTHER ONE WAS OPENED AND USED INSTEAD. REMOVED FROM FIELD AND GIVEN TO MANAGEMENT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213309 ↗MalfunctionMar 26, 2021Contamination
OUR STAFF HAVE REPORTED AN "OILY SUBSTANCE" CONDENSING ON THE INSIDE OF OUR HEAT AND MOISTURE EXCHANGERS/FILTERS (HMEFS) THAT ARE USED INLINE WITH OUR VENTILATORS. WE HAVE PUT THEM OUT OF SERVICE UNTIL FURTHER INVESTIGATION.
Patient problems: Insufficient Information
MAUDE report 11574448 ↗
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- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit2 recalls2 deaths325 reports
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- 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.