RadiaLux™ 50-101-1 (UDI 00763000432805)Recalls & reported problems
Medtronic Navigation, Inc. · RETRACTOR 50-101-1 RADIALUX CE PINK · Class 1
All models of RadiaLux (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000432805), received between Oct 1, 2022 and Oct 1, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Dec 8, 2022Open, Classified
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
Z-0953-2023 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
- Failure to Power Up2
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.
MalfunctionOct 1, 2022Break; Failure to Power Up; Break; Failure to Power Up
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING TWO HANDPIECES. IT WAS REPORTED THAT THE SITE HAS TWO HANDPIECES THAT WOULD NOT POWER ON BECAUSE WHEN THE PROTECTIVE TAB WAS REMOVED, IT BROKE, PREVENTING PROPER CONTACT BETWEEN WITH THE BATTERY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15525708 ↗MalfunctionOct 1, 2022Break; Failure to Power Up; Break; Failure to Power Up
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING TWO HANDPIECES. IT WAS REPORTED THAT THE SITE HAS TWO HANDPIECES THAT WOULD NOT POWER ON BECAUSE WHEN THE PROTECTIVE TAB WAS REMOVED, IT BROKE, PREVENTING PROPER CONTACT BETWEEN WITH THE BATTERY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15524517 ↗
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- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 3104RIntegra Lifesciences Corporation · RETRACTOR1 recall0 reports
- Omni-Tract® 3601Integra Lifesciences Corporation · RETRACTOR1 recall0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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