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HUDSON RCI IPN048949Recalls & reported problems

Teleflex Incorporated · ET TUBE,CUFFED ORAL,SPIRAL-FLEX 6.5 · Class 2

All models of HUDSON RCI (152)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704616975), received between Aug 20, 2021 and Aug 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Device problems

  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 20, 2021Material Rupture; Material Rupture

    IT WAS REPORTED THAT "THE PILOT BALLOON WAS FOUND TORN DURING USE ON A PATIENT. THEREFORE, THE TUBE WAS REPLACED WITH A NEW UNIT". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12348349 ↗

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Sources and updates

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