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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All LARYNGOSCOPE, RIGID devices →

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