Onyx Frontier™ ONYXNG45030UXRecalls & reported problems
Medtronic, Inc. · STENT ONYXNG45030UX ONYX 4.50X30RX · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000511777), received between May 10, 2023 and May 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT HIGHLY TORTUOUS LESION WITH A 180-DEGREE BEND, MILD CALCIUM AND 90% STENOSIS, LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 3.0 X 12MM COMPLAINT BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT BALLOON RUPTURED DURING STENT DEPLOYMENT, AND THE DISTAL PORTION OF THE BALLOON BROKE OFF IN THE VESSEL. IT WAS DETAILED THAT THE PROXIMAL RCA LESION WAS WIRED, AND AFTER THE LESION WAS PRE-DILATED THE ONYX FRONTIER WAS DELIVERED TO THE LESION AREA. UPON DEPLOYMENT OF THE STENT TO 14 ATM, A CINE IMAGE REVEALED CONCERNING APPEARANCE OF THE AREA BEING TREATED. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED AND WAS NOTED TO HAVE COME BACK EASILY, MORE EASILY THAN USUAL. UPON REVIEW OF THE IMAGES, THE DISTAL RADIOPAQUE MARKER OF THE BALLOON REMAINED IN THE ARTERY AFTER THE SDS WAS WITHDRAWN. THE STENT WAS SUCCESSFULLY DEPLOYED BUT NOW NO SMALL BALLOONS WOUL
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 16901215 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page