RUSCH IPN049332Recalls & reported problems
Teleflex Incorporated · Rusch Polaris FO Blade, Mac 3 · Class 1
- 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 14026704629692), received between Mar 8, 2021 and Jul 31, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Display or Visual Feedback Problem1
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.
MalfunctionJul 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT: "THIS PADDLE HAS A VERY SHORT LIGHT AND WHEN A PATIENT MUST BE INTUBATED, THE LIGHT IS NOT POWERFUL ENOUGH TO BE ABLE TO SEE THE LARYNX AND INTUBATE CORRECTLY. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19870741 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED "I LITERALLY JUST OPENED THE BLADE TO HAND IT TO THE CRNA TO INTUBATE AND IT SNAPPED OFF. THE HANDLE WAS COMPLETELY NORMAL AND IT DIDN'T LOOK LIKE THERE WERE ANY DEFECTS. WHEN I OPENED THE NEXT MAC 3 BLADE AND PUT IT ON THE SAME HANDLE THERE WAS NO ISSUE". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11437377 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.