Onyx Frontier™ ONYXNG45026UXRecalls & reported problems
Medtronic, Inc. · STENT ONYXNG45026UX ONYX 4.50X26RX · 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 00763000511760), received between Aug 14, 2023 and Aug 14, 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
- Leak/Splash1
Patient problems
- Insufficient Information1
- 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.
InjuryAug 14, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS TREATED WITH A ROTABLATOR AND SHOCKWAVE BALLOON. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING STENT DEPLOYMENT. AN INFLATION PRESSURE OF 8ATM WAS APPLIED PRIOR TO THE BALLOON BURST. NO PRIOR INFLATIONS HAD BEEN PERFORMED WHEN THE ISSUE OCCURRED. THE STENT WAS DEPLOYED AND POST DILATED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17538909 ↗
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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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