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HUDSON RCI IPN042652Recalls & reported problems

Teleflex Incorporated · BACTERIAL/VIRAL FILTER · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026704399208), received between Feb 16, 2021 and Feb 19, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (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.

Most reported problems

Device problems

  • Complete Blockage1
  • Disconnection1

Patient problems

  • Airway Obstruction1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 19, 2021Complete Blockage; Complete Blockage

    CUSTOMER REPORTED THE PLASTIC PIECE THAT CONNECTS TO THE PATIENT ET TUBE AND HOOKS TO CIRCUIT WAS BLOCKED BY AN UNCUT PIECE OF PLASTIC. "PATIENT INDUCED UNDER GENERAL ANESTHESIA, LMA APPLIED. UNABLE TO HAVE RETURN OF ETCO2. CHANGED LMA TO ETT AND INTUBATED PATIENT, GRADE 1 VIEW. NO ETCO2, HIGH PEAK AIRWAY PRESSURES. PT HAD HISTORY OF ASTHMA, SO SUSPECTED BRONCHOSPASM (OCCLUSION OF THE AIRWAY OF SOME SORT). RECONFIRMED BY DL ETT WAS IN TRACHEA, MASK VENTILATION ALBUTEROL GIVEN. CALLED FOR HELP. EPINEPHRINE GIVEN. ETT SUCTIONED WITH NO OBSTRUCTION NOTED. STILL NO ETCO2 AND HIGH PEAK AIRWAY PRESSURES. CHANGED PATIENT FROM VENTILATOR TO AMBU BAG AND IMMEDIATE FOGGING OF ETT AND BILATERAL BREATH SOUNDS SO OCCLUSION WAS IN THE ANESTHESIA VENTILATOR CIRCUIT. REMOVED THE VIRAL FILTER FROM THE CIRCUIT AND IMMEDIATE ETCO2 WITH NORMAL PEAK AIRWAY PRESSURES." THE CUSTOMER REPORTED UPON INSPECTION THERE WAS "AN ENTIRE PLASTIC PIECE" THAT OCCLUDED THE FILTER AND MADE A "COMPLETE OBSTRUCTION TO THE PATIENT'S AIRWAY". PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

    Patient problems: Airway Obstruction

    MAUDE report 11348093 ↗
  • MalfunctionFeb 16, 2021Disconnection; Disconnection

    IT WAS REPORTED THE "FILTER POPS OFF VENTILATOR DURING USE ON PATIENTS. INCIDENTS OCCURRED ON TRILOGY, V-60, AND LTV VENTS". NO PATIENT INJURTY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11333764 ↗

Other Filter, bacterial, breathing-circuit devices

All Filter, bacterial, breathing-circuit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.