Onyx Frontier™ ONYXNG50030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000511838), received between Jun 7, 2023 and Mar 25, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Entrapment of Device; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS STATED THAT THE ONYX FRONTIER STENT CAME OFF INSIDE THE TELESCOPE WHEN THE STENT COULD NOT BE DELIVERED TO THE LESION. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE ONYX FRONTIER DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE ONYX FRONTIER DEVICE AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TELESCOPE. EXCESSIVE FORCE WAS USED DURING DELIVERY OF BOTH DEVICES. IT WAS NOTED THAT THE STENT FELT TIGHT IN THE TELESCOPE DURING REMOVAL OF THE STENT. THE DISLODGED STENT WAS REMOVED WITHIN THE TELESCOPE TOGETHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686871 ↗
• InjuryJun 7, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS ATTEMPTED TO BE REMOVED DURING THE PROCEDURE BUT IT WAS LODGED IN THE RADIAL ARTERY. THE DISLODGED STENT WAS REMOVED THE NEXT DAY IN THE OPERATING ROOM. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17083437 ↗