Onyx Frontier™ ONYXNG50015UXRecalls & reported problems
Medtronic, Inc. · STENT ONYXNG50015UX ONYX 5.00X15RX · Class 3 · Implant
All models of Onyx Frontier (71)
Data updated Oct 18, 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 00763000511791), received between Jul 10, 2023 and Jul 10, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
- Difficult to Insert1
- Material Deformation1
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.
MalfunctionJul 10, 2023Difficult to Insert; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation
AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS (DES) TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 75% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TELESCOPE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY OF THE TELESCOPE DEVICE. NEGATIVE PREP WAS PERFORMED ON BOTH ONYX FRONTIER STENTS WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE 5.00MM DIAMETER ONYX FRONTIER STENTS COULD NOT PASS OUT THROUGH THE DISTAL END OF THE TELESCOPE GEC. IT WAS DETAILED THAT BOTH STENTS WERE DAMAGED. A 4.5MM STENT WAS ABLE TO PASS. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17286875 ↗
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- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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