Onyx Frontier™ ONYXNG30030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000511517), received between Mar 2, 2023 and Jun 20, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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.

• InjuryJun 20, 2025Migration or Expulsion of Device; Device Damaged by Another Device; Material Deformation; Migration or Expulsion of Device; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE 2.5X38MM ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, SEVERELY CALCIFIED WITH 90% STENOSIS AND LOCATED IN THE MID DIAGONAL BRANCH. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DISLODGED STENT WAS BEING REMOVED WITH A SNARE; HOWEVER, DURING REMOVAL IT SNAGGED A 3.0X30MM ONYX FRONTIER DES WHICH HAD BEEN PREVIOUSLY IMPLANTED AT THE OSTIUM OF THE LEFT CIRCUMFLEX ARTERY (LCX). THE 3.0X30MM ONYX FRONTIER DES HAD SOME STRUTS EXTENDING INTO THE LEFT MAIN (LM) ARTERY AND HAD BEEN IMPLANTED APPROXIMATELY EIGHTEEN DAYS PREVIOUSLY. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED THAT THE WIRE INTENDED FOR THE DIAGONAL WENT THROUGH ONE OF THE CELLS OF THE 3.0X30MM ONYX FRONTIER DES, AND WHEN THE SNARED 2.5X38MM ONYX FRONTIER DES WAS REMOVED IT PULLED THE 3.0X30MM ONYX FRONTIER DES OUT WITH IT. DURING THE INITIAL PROCEDURE THE 3.0X30MM ONYX FRONTIER DES HAD BEEN INSPECTED PRIOR TO USE AND WAS NEGATIVELY PREPPED WITHOUT ISSUES. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297041 ↗
• MalfunctionMay 8, 2025Entrapment of Device; Difficult to Remove; Material Deformation; Entrapment of Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY STENT, THERE WERE DIFFICULTIES IN REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO EXCESSIVE FORCE USED DURING DELIVERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED, AND NO NEGATIVE PREP WAS PERFORMED. THE DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984553 ↗
• InjurySep 13, 2024Inflation Problem; Activation, Positioning or Separation Problem; Material Deformation; Material Split, Cut or Torn; Inflation Problem; Activation, Positioning or Separation Problem; Material Deformation; Material Split, Cut or Torn

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED 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 INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT. IT WAS STATED THAT UPON DEPLOYMENT, THE STENTS BALLOON ONLY PARTIALLY INFLATED LEAVING THE DISTAL END OF THE STENT NOT APPOSED TO THE VESSEL. MULITPLE SC AND NC BALLOONS WERE USED TO GET THE STENT OPEN AND APPOSED TO THE VESSEL. AFTER THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE STENTS BALLOON WAS INFLATED TO CHECK TO SEE IF THE BALLOON HAD RUPTURED OR HAD ANY HOLES. UPON INSPECTION OF BALLOON NO N OTICEABLE DAMAGE WAS NOTED TO BALLOON. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20211227 ↗
• MalfunctionApr 25, 2023Detachment 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. IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. THE CATHETER FRACTURED AT THE LUER/HUB. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805830 ↗
• InjuryMar 2, 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 SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE MID RCA WITH DISTAL AND PROXIMAL LESIONS WAS PREDILATED WITH MULTIPLE NON-MEDTRONIC NON-COMPLIANT (NC) BALLOONS . A 6F LAUNCHER GUIDE CATHETER, A NON-MEDTRONIC WIRE AND A NON MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED. THE STENT ADVANCED TO THE MID RCA THROUGH THE NON MDT GEC AND WHEN THE STENT EXITED THE DEVICE IT COULD NOT BE ADVANCED OR BE PULLED BACK INTO THE GEC. IT WAS ALSO REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. TWO 3.0 X 15MM ONYX FRONTIER STENTS WERE USED TO SM

  Patient problems: Insufficient Information

  MAUDE report 16467547 ↗