Onyx Frontier™ ONYXNG40008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000511630), received between Jun 13, 2023 and Aug 18, 2025 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE LESION BEING TREATED WAS NON TORTUOUS, NON CALCIFIED, WITH 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS STATED THAT THE LESION WAS A BIFURCATION LESION. THE DIAGONAL ARTERY WAS STENTED FIRST, WHICH JUTTED INTO THE LAD. PLAQUE WAS SNOW PLOWED INTO THE LAD WHICH REQUIRED THE LAD TO BE STENTED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE STENT WAS ORIGINALLY ATTEMPTED TO BE DELIVERED BUT THE STENT FROM THE DIAGONAL WAS IMPEDING DELIVERY. THE SYSTEM WAS SUCCESSFULLY REMOVED AND THE LESION AND DIAGONAL STENT WAS PREDILATED WITH A 3.0 X 12MM EUPHORA BALLOON. THEN THE STENT WAS ATTEMPTED TO BE DELIVERED AGAIN. A 7F LAUNCHER GUIDE CATHETER, TWO NON-MEDTRONIC WIRES AND THE 3.0 X 12MM EUPHORA WERE BEING USED IN THE DIAGONAL. THE KISSING STENT AND BALLOON TECHNIQUE WAS INTENDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825251 ↗
• DeathJul 30, 2025Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE STENT WAS DAMAGED BY ANOTHER DEVICE. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED LOCATED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE STENT WAS PLACED AND SUCCESSFULLY DEPLOYED IN THE LM. ANOTHER STENT WAS THEN PLACED IN THE LEFT ANTERIOR DESCENDING A RTERY(LAD). ANOTHER STENT WAS PLACED IN THE RAMUS USING A NON-MEDTRONIC GUIDEWIRE. WHEN IT WAS ATTEMPTED TO RETRIEVE THE GUIDEWIRE, IT LOCKED UP WITH THE DEPLOYED STENT IN THE LM. THE GUIDEWIRE WAS PULLED AND THE STENT WAS EXPANDED AND REMOVED FROM THE PATIENT STUCK TO THE GUIDEWIRE. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE STENT WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE PATIENT DIED THE FOLLOWING DAY. THE PHYSICIAN ASSESSED THAT THE DEATH WAS RELATED TO GASTROINTESTINAL (GI) BLEED AND WAS NOT DUE TO THE ISSUES ENCOUNTERED WITH THE STENT.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 22662798 ↗
• InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, AN ONYX FRONTIER CORONARY DRUG ELUTING STENT BECAME DISLODGED FROM THE DELIVERY DEVICE AND TRAVELED TO THE LEFT PERONEAL ARTERY WHERE IT WAS THEN INFLATED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 21582964 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE STENT WAS DEPLOYED SUCCESSFULLY. IT WAS REPORTED THAT THE STENT DEPLOYMENT BALLOON SYSTEM CAME APART WHILE BEING REMOVED AFTER DEPLOYING THE STENT. THE DELIVERY SYSTEM WAS INSIDE THE GUIDE CATHETER AT THE TIME. THE GUIDE WAS SUCCESSFULLY REMOVED WITH THE STENT SYSTEM INSIDE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461968 ↗
• MalfunctionJun 13, 2023Defective Component; Defective Component

  AN ATTEMPT WAS MADE TO USE ONE 4.0X8MM ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE STENT APPEARED TO BE LONGER THAN 8MM. A 12MM LENGTH NON-MEDTRONIC BALLOON WAS USED AND IT WAS NOTED TO BE THE SAME SIZE AS THE STENT. THE ONYX FRONTIER STENT WAS IMPLANTED WITH NO ISSUES DESPITE THAT IT MAY HAVE BEEN LONGER THAN 8MM. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121357 ↗