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HUDSON RCI IPN913843Recalls & reported problems

Teleflex Incorporated · Neonatal ISO-GARD Drain Breathing Circuit Dual Heated Limb with Dual Drain · Class 2

All models of HUDSON RCI (152)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704660510), received between Apr 5, 2021 and Oct 18, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Leak/Splash4
  • Disconnection1
  • Melted1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 18, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED "HEATED WIRE CIRCUIT DID NOT PASS THE VENT TEST PRIOR TO USE ON PATIENT. DURING TEST, A LEAK COULD BE HEARD (POSSIBLY A FROM A SMALL HOLE IN THE CIRCUIT)". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12646851 ↗
  • MalfunctionOct 18, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED "HEATED WIRE CIRCUIT DID NOT PASS THE VENT TEST PRIOR TO USE ON PATIENT. DURING TEST, A LEAK COULD BE HEARD (POSSIBLY A FROM A SMALL HOLE IN THE CIRCUIT)". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12646837 ↗
  • MalfunctionOct 18, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED "HEATED WIRE CIRCUIT DID NOT PASS THE VENT TEST PRIOR TO USE ON PATIENT. DURING TEST, A LEAK COULD BE HEARD (POSSIBLY A FROM A SMALL HOLE IN THE CIRCUIT)". NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12646807 ↗
  • MalfunctionOct 8, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED "HEATED EXPIRATORY WIRE CIRCUIT HAD A PINHOLE. CIRCUIT WAS REPLACED AND NO ISSUES". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12597962 ↗
  • MalfunctionAug 6, 2021Melted; Melted

    IT WAS REPORTED "HEATED EXPIRATORY WIRE CIRCUIT MELTING IN A 1-2 INCH PORTION DURING VENT USE". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12287637 ↗
  • MalfunctionApr 5, 2021Disconnection; Disconnection

    IT WAS REPORTED THE "CIRCUIT BECAME DISCONNECTED AT THE CUP". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "STABLE ON ROOM AIR". DEVICE WAS REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11613345 ↗

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Sources and updates

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