Onyx Frontier™ ONYXNG25038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000511357), received between Sep 29, 2023 and Mar 25, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE TARGET LESION WAS LOCATED IN THE PROXIMAL AND MID SECTIONS OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WHICH EXHIBITED SEVERE TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS INSPECTED PRIOR TO USE AND 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. THE PROCEDURE WAS COMPLETED USING ANOTHER ONYX FRONTIER DEVICE WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688022 ↗
• InjuryJun 20, 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 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 22297031 ↗
• InjuryJun 10, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER DRUG ELUTING CORONARY STENT AND ONE NC EUPHORA CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED FOR BOTH DEVICES. THE LESION BEING TREATED WAS NON-TORTUOUS, NON-CALCIFIED WITH 70% STENOSIS IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE BOTH INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOR BOTH DEVICES WITH NO ISSUES NOTED. THE ONYX FRONTIER DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE NC EUPHORA DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF BOTH DEVICES. THE ONYX FRONTIER DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE INFLATION DEVICE WAS CHANGED BUT DEFLATION WAS STILL UNSUCCESSFUL. AN EMPTY 30CC SYRINGE WAS USED, WHICH ALLOWED THE BALLOON TO PARTIALLY DEFLATE AND BE REMOVED FROM THE DRUG ELUTING STENT. THIS WAS FOLLOWED BY CONTINUED SLOW DEFLATION AND REMOVAL. THE NC EUPHORA BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THERE WERE MULTIPLE ATTEMPTS TO DEFLATE WITH THE INFLATION DEVICE WHICH WERE UNSUCCESSFUL. FOLLOWI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174069 ↗
• MalfunctionJun 3, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. AN ATTEMPT WAS MADE TO DELIVER THE DEVICE TO THE LESION THROUGH A 5.5MM NON-MEDTRONIC GUIDE EXTENSION CATHETER WHEN RESISTANCE WAS FELT. THE DEVICE WAS REMOVED, AND UPON REMOVAL IT WAS OBSERVED THAT BOTH THE PROXIMAL AND DISTAL EDGE OF THE STENT HAD FLARED STRUTS AND APPEARED DAMAGED. THE LESION WAS FURTHER PRE-DILATION USING ONE 2.5X15MM BALLOON, AND THE PROCEDURE WAS COMPLETED USING ONE 2.5X34MM ONYX FRONTIER STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132013 ↗
• MalfunctionMar 26, 2025Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE INVOLVING ONE ONYX FRONTIER DRUG-ELUTING STENT, A BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 12 ATM ON THE FIRST INFLATION. THE PROCEDURE WAS CONDUCTED IN THE MID-SECTION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, WHICH HAD AN 80% LESION STENOSIS, MILD TORTUOSITY, AND MODERATE CALCIFICATION. THE LESION WAS PRE-DILATED, AND NO RESISTANCE OR EXCESSIVE FORCE WAS ENCOUNTERED DURING DEVICE DELIVERY. THE DEVICE WAS INSPECTED, AND NEGATIVE PREP WAS PERFORMED WITHOUT ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696040 ↗
• InjurySep 3, 2024Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 2.5X38MM ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE MID PORTION OF THE CIRCUMFLEX (CX) ARTERY. THERE WAS A STENT ALREADY IMPLANTED IN THE MID CX FROM A PRIOR PROCEDURE. A 6F NON-MEDTRONIC (MDT) GUIDE WAS USED WITH A .014 NON-MDT GUIDEWIRE. A 2.5X20MM NON-MDT BALLOON WAS ADVANCED TO THE DISTAL LESION OF THE CX AND PASSED THROUGH THE PREVIOUSLY IMPLANTED PROXIMAL/MID CX STENT WITH NO ISSUES. THE BALLOON INFLATED TO 8 ATM AND REMOVED WITH NO ISSUE. IT WAS REPORTED THAT THE 2.5X38MM ONYX FRONTIER DES WAS ADVANCED INTO THE CX ARTERY AND SEEMED TO HAVE RESISTANCE WHEN TRYING TO PASS THE PREVIOUSLY IMPLANTED STENT IN THE MID PORTION OF THE CX. AN ATTEMPT WAS THEN MADE TO PULL BACK THE ONYX FRONTIER DES WITH A BIT OF FORCE USED. THE STENT DELIVERY SYSTEM WAS PULLED AND CAME OUT ALONG WITH THE .014 GUIDEWIRE. AT THIS POINT THE ONYX FRONTIER DES REMAINED IN THE CX ARTERY AND SEEMED TO HAVE FORESHORTENED TO AROUND 12MM. A 3.0X15MM NC NON-MDT BALLOON WAS PLACED INTO THE CX ARTERY AND INFLATED TO PUSH THE DISLODGED STENT UP AGAINST THE ARTERIAL WALL, WITH SUCCESS. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND SHOWED A SATISFIED RE

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

  MAUDE report 20124128 ↗
• MalfunctionJun 25, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT WAS ADVANCED IN THE PATIENT AND THEN REMOVED TO ADD A NON-MEDTRONIC GUIDE EXTENSION CATHETER TO PLATFORM. UPON INSPECTION AFTER REMOVAL THE STENT STRUT WAS NOTED TO BE DEFORMED. THE DEVICE WAS REPLACED WITH A NEW STENT OF THE SAME SIZE AND MODEL, AND THE PROCEDURE WAS COMPLETED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604238 ↗
• MalfunctionMay 1, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. 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. IT DETAILED THAT THE DEVICE WOULD NOT ADVANCE AND WHEN REMOVED IT WAS FOUND THAT THE STENT STRUT WAS LIFTED. THE PROCEDURE WAS COMPLETED WAS A SAME SIZE ONYX FRONTIER STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219063 ↗
• MalfunctionOct 27, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  AN ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS RETURNED FOR ANALYSIS. THE STENT WAS USED IN A PROCEDURE. THERE WAS NO REPORTED COMPLAINT AGAINST THE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18018316 ↗
• InjurySep 29, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED, NON-TORTUOUS LESION WITH 95% STENOSIS IN THE PROXIMAL DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS ATTEMPTED TO BE DELIVERED TO THE LESION MULTIPLE TIMES BUT COULD NOT GET ALL THE WAY DOWN. ON REMOVAL OF THE STENT DELIVERY SYSTEM, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. IT WAS BELIEVED THAT THE STENT WAS SEEN IN THE CURVE OF THE DISTAL PORTION OF THE GUIDE, THEREFORE A BALLOON WAS INSERTED PAST THE DISTAL PORTION AND WAS INFLATED TO OCCLUDE THE GUIDE AND REMOVE THE WHOLE SYSTEM, INCLUDING THE TOUY AND SHEATH. EVERYTHING WAS FLUSHED AND WIRES WERE RUN THROUGH THE SYSTEM, OUTSIDE THE BODY, HOWEVER NO STENT WAS FOUND. THE ENTIRE PATIENT BODY WAS THEN X-RAYED, BUT THE STENT WAS NOT FOUND. PATIENT WAS SENT TO COMPUTERIZED TOMOGRAPHY (CT) AFTER THE PROCEDURE

  Patient problems: Insufficient Information

  MAUDE report 17841941 ↗