Onyx Frontier™ ONYXNG25008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000511272), received between Nov 3, 2022 and Jul 14, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE STENT DISLODGED DURING DELIVERY TO/AT THE LESION. A SECOND STENT WAS INSERTED AND INFLATED AT THE SITE OF THE DISLODGMENT CRUSHING THE DISLODGED STENT AGAINST THE WALL OF THE VESSEL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493189 ↗
• InjuryMar 28, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO A LESION, STENT DISLODGEMENT OCCURRED. THE STENT COULD NOT BE RETRIEVED AND WAS CRUSHED IN PLACE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 21718065 ↗
• MalfunctionJan 14, 2025Improper or Incorrect Procedure or Method; Defective Component; Improper or Incorrect Procedure or Method; Defective Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER DRUG ELUTING STENTS, BOTH STENTS APPEARED LONGER THAN 8MM IN LENGTH. THE LESION BEING TREATED WAS A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 85% STENOSIS IN THE PROXIMAL DIAGONAL BRANCH. THE FIRST STENT STENT WAS INSPECTED WITH NO ISSUES NOTED. THE SECOND STENT WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON EITHER DEVICE. THE LESION WAS PRE-DILATED. THE STENTS DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE STENTS AND EXCESSIVE FORCE WAS NOT USED. WITH THE FIRST 2.5 X 8MM ONYX FRONTIER STENT, IT WAS FELT THAT THE STENT LOOKED LONGER THAN 8MM IN LENGTH UNDER FLUOROSCOPY. THE STENT WAS REMOVED FROM THE PATIENT AND THE LENGTH OF THE STENT WAS MEASURED AT 10MM IN LENGTH. THIS STENT WAS NOT IMPLANTED. IT WAS THEN ATTEMPTED TO USE ANOTHER 2.5 X 8MM ONYX FRONTIER STENT. THE STENT LENGTH WAS MEASURED AGAIN, USING A STERILE RULER, AND IT MEASURED 10MM. THE PROCEDURE WENT AHEAD AND THE SECOND STENT WHICH WAS INSERTED INTO THE PATIENT AND THE STENT WAS DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148111 ↗
• MalfunctionDec 11, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING INSERTION INTO THE HOMEOSTATIC VALVE AND FELL OFF INSIDE THE GUIDE CATHETER. THE LESION TO BE TREATED WAS MODERATELY TORTUOUS, MILDLY CALCIFIED WITH 80% STENOSIS AND LOCATED IN THE PROXIMAL DIAGONAL BRANCH. THE DEVICE WAS INSPECTED, AND NEGATIVE PREP WAS PERFORMED WITHOUT ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT WAS NOT IMPLANTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900613 ↗
• MalfunctionSep 20, 2024Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Deformation Due to Compressive Stress; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A LESION. IT WAS REPORTED THAT ONE OF THE STENTS WAS UNABLE TO BE DELIVERED, AND WHEN THE STENT WAS BROUGHT OUT ON THE CATHETER IT WAS NO LONGER SMOOTH ON THE CATHETER. IT WAS ALSO REPORTED THAT THE SECOND STENT CAME OFF THE DELIVERY SYSTEM CATHETER. AN ATTEMPT WAS MADE TO LOOK FOR THE STENT UNDER FLUORO, BUT THE STENT COULD NOT BE FOUND. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266988 ↗
• MalfunctionSep 20, 2024Deformation Due to Compressive Stress; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A LESION. IT WAS REPORTED THAT ONE OF THE STENTS WAS UNABLE TO BE DELIVERED, AND WHEN THE STENT WAS BROUGHT OUT ON THE CATHETER IT WAS NO LONGER SMOOTH ON THE CATHETER. IT WAS ALSO REPORTED THAT THE SECOND STENT CAME OFF THE DELIVERY SYSTEM CATHETER. AN ATTEMPT WAS MADE TO LOOK FOR THE STENT UNDER FLUORO, BUT THE STENT COULD NOT BE FOUND. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266969 ↗
• InjuryJan 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE THREE ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY CALCIFIED LESION IN THE MID/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SECOND DEVICE (ONYXNG25015UX). EXCESSIVE FORCE WAS USED DURING DELIVERY OF ALL DEVICES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION FOR THE FIRST TWO DEVICE (ONYXNG25008UX ONYXNG25015UX). THE DISLODGED STENTS WERE NOT REMOVED. IT WAS POSSIBLE TO GET A BALLOON CATHETER THROUGH BOTH STENTS AND THE STENTS WERE DEPLOYED. SEVERAL BALLOONS WERE USED. FOR THE THIRD DEVICE (ONYXNG22526UX), IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16085234 ↗
• MalfunctionNov 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721776 ↗