Onyx Frontier™ ONYXNG50022UXRecalls & reported problems
Medtronic, Inc. · STENT ONYXNG50022UX ONYX 5.00X22RX · 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 00763000511814), received between Jan 12, 2024 and Jan 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Difficult to Advance1
- 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.
MalfunctionJan 12, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation
THE PATIENT PRESENTED TO HOSPITAL WITH DECLINING LEFT VENTRICULAR FUNCTION AND SHORTNESS OF BREATH (ANGINA), FOR DIAGNOSTIC CARDIAC CATHETERIZATION. INDICATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS ANGINA AND CONGESTIVE HEART FAILURE. AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A 4.0X12MM BALLOON TO 14ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE RCA WAS ENGAGED WITH A 6F GUIDE CATHETER. A 300CM 0.014 NON-MEDTRONIC (MDT) GUIDEWIRE WAS ADVANCED BEYOND THE CULPRIT LESION, DISTALLY IN THE VESSEL, WITHOUT COMPLICATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-MDT DEVICE. DIFFICULTY WAS NOTED DURING ADVANCEMENT OF THE ONYX FRONTIER DEVICE THROUGH A TELESCOPE GUIDE EXTENSION CATHETER BEFORE IT REACHED THE VESSEL. T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18501555 ↗
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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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