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RadiaLux™ 50-101-1 (UDI 00763000280055)Recalls & reported problems

Medtronic Navigation, Inc. · RETRACTOR 50-101-1 RADIALUX US · Class 1

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 00763000280055), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Power Up” (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.

Most reported problems

Device problems

  • Failure to Power Up1

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.

  • MalfunctionNov 24, 2020Failure to Power Up

    MIDDLE-AGED FEMALE WITH HISTORY OF BREAST CANCER POSITIVE GENE MUTATION. HAVING SURGERY FOR BREAST RECONSTRUCTION AND IMPLANT, THE MEDTRONIC RADIALUX LIGHTED RETRACTOR WOULD NOT TURN ON. NO KNOWN HARM TO PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10894090 ↗

Other RETRACTOR devices

All RETRACTOR devices →

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