RUSCH IPN048415Recalls & reported problems
Teleflex Incorporated · RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 0 · Class 1
Data updated Oct 13, 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 14026704626141), received between Apr 30, 2024 and Apr 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sharp Edges” (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
- Sharp Edges1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2024Sharp Edges; Sharp Edges
IT WAS REPORTED THAT: THE PEDIATRIC PATIENT WAS BEING INTUBATED FOR RESPIRATORY INSUFFICIENCY FOLLOWING DELIVERY. THE APPROPRIATE SIZE LARYNGOSCOPE BLADE FOR THE SIZE PATIENT WAS SELECTED FOR THE PROCEDURE. NEONATE NURSE PRACTITIONER (NNP) ATTEMPTED AIRWAY PLACEMENT AND WAS UNABLE TO GAIN VIEW DUE TO SIZE AND WIDTH OF BLADE. UPON WITHDRAWAL OF THE LARYNGOSCOPE FROM THE MOUTH, THE PATIENTS' GUMS RECEIVED A SMALL ABRASION AND SUBSEQUENT BLEEDING FROM THE BARE METAL EDGES OF THE LARYNGOSCOPE. THE HANDLE THAT CAUSED THE ABRASION IS MUCH WIDER THAN OTHERS AND DOES NOT HAVE A SAFETY COATING ON THE BLADE. BECAUSE OF THE DEVICE ISSUES, THERE WERE INCREASED ATTEMPTS AT INTUBATION AND ABRASION TO TISSUES. PROVIDER FELT THAT THE DESIGN OF LARYNGOSCOPE BLADE-TOO WIDE, ROUGH EDGES, AND PROTRUDING LIGHT HOUSING. THERE WAS NO OTHER REPORTED PATIENT CONSEQUENCE FROM THE INCIDENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19211513 ↗
Other LARYNGOSCOPE, RIGID devices
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls202 reports
- McGRATH MAC 300-000-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 death205 reports
- n.a. 8404HXKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID242 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID2 deaths192 reports
- McGRATH MAC 301-000-000Covidien LP · LARYNGOSCOPE, RIGID2 recalls90 reports
- n.a. 8404BXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID141 reports
- n/a 8404AXCKarl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID108 reports
- McGRATH 340-000-000Covidien LP · LARYNGOSCOPE, RIGID84 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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