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RUSCH IPN041899Recalls & reported problems

Teleflex Incorporated · Laryngectomy tube, cuffed · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026704012916), received between Apr 13, 2023 and Apr 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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.

Most reported problems

Device problems

  • Material Split, Cut or Torn2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionApr 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    REPORTED ISSUE: FEMALE PATIENT (GRA), 50-YEARS-OLD, HOSPITALIZED FOR A SQUAMOUS CELL CARCINOMA ON LEFT POSTERIOR PHARYNGEAL WALL. IN PREOPERATIVE SETTING, A TRACHEOSTOMY PERFORMED WITH MONTANDON TUBE. TWICE, ON 2 DIFFERENT DEVICES FROM 2 DIFFERENT LOTS, DURING INSERTION, THE CUFF IS PIERCED. THE CUFF WAS PRE-TESTED BEFORE USE WITHOUT ANY ISSUES. ADDITIONAL INFORMATION INDICATES THAT ON REMOVAL OF THE TUBE A HOLE WAS OBSERVED. THERE WAS NO INJURY AND THE PATIENT'S CONDITION REPORTED AS FINE. ASSOCIATED REPORT: 8040412-2023-00150.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16733467 ↗
  • MalfunctionApr 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    REPORTED ISSUE: FEMALE PATIENT (GRA), 50-YEARS-OLD, HOSPITALIZED FOR A SQUAMOUS CELL CARCINOMA ON LEFT POSTERIOR PHARYNGEAL WALL. IN PREOPERATIVE SETTING, A TRACHEOSTOMY PERFORMED WITH MONTANDON TUBE. TWICE, ON 2 DIFFERENT DEVICES FROM 2 DIFFERENT LOTS, DURING INSERTION, THE CUFF IS PIERCED. THE CUFF WAS PRE-TESTED BEFORE USE WITHOUT ANY ISSUES. ADDITIONAL INFORMATION INDICATES THAT ON REMOVAL OF THE TUBE A HOLE WAS OBSERVED. THERE WAS NO INJURY AND THE PATIENT'S CONDITION REPORTED AS FINE. 8040412-2023-00151.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16733342 ↗

Other Tube, tracheostomy (w/wo connector) devices

All Tube, tracheostomy (w/wo connector) devices →

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