Onyx Frontier™ ONYXNG35026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000511593), received between Nov 11, 2022 and Dec 19, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED IN VITRO. THE STENT BALLOON WAS USED IN THE PATIENT AND DILATED AT THE LESION SITE, LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED NO TORTUOSITY, SEVERE CALCIFICATION AND 99% STENOSIS. IT WAS NOT NOTICED THAT THE STENT HAD DISLODGED UNTIL AFTER DELIVERY OF THE STENT BALLOON TO THE LESION SIGHT. THE GUIDE WAS INSPECTED AND THE STENT WAS NOT FOUND ON THE GUIDE. THE STENT WAS FOUND HALFWAY OUTSIDE THE SHEATH THAT IT WAS PACKAGED IN WHICH WAS STILL ON THE STYLET. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853554 ↗
• MalfunctionNov 13, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO OR AT THE LESION LOCATED IN THE MID SEGMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION EXHIBITED SEVERE TORTUOSITY, SEVERE CALCIFICATION WITH 80% LESION STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DISLODGED STENT DID NOT COMPLETELY COME OFF THE DELIVERY BALLOON, THEREFORE IT WAS POSSIBLE TO PULL THE STENT OUT OF THE LESION WITH THE STENT DELIVERY BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547077 ↗
• MalfunctionAug 15, 2025Improper or Incorrect Procedure or Method; Material Deformation; Positioning Problem; Improper or Incorrect Procedure or Method; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT WAS UNABLE TO CROSS THE LESION AND DEFORMED IN VIVO DURING POSITIONING. THE STENT WAS INTACT AT INSERTION. THE LESION BEING TREATED WAS APPROXIMATELY 95% CALCIFIED WITH APPROXIMATELY 95% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE RCA WAS NOT PARTICULARLY TORTUOUS HOWEVER, AREAS IN THE VESSEL VARIED IN APPEARANCE IN STENOSIS SEVERITY WITH HARD AND SOFT PLAQUE VARIATIONS. A NUMBER OF LESIONS WERE PRESENT. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED STAGGERED HARD CALCIUM PRESENT. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO ADVANCE THE DEVICE TO THE OSTIAL POSTERIOR DESCENDING ARTERY (PDA). IT WAS INTENDED TO ADVANCE A LITTLE FURTHER INTO THE PDA FOR PLACEMENT HOWEVER THE STENT WOULD NOT PROCEED FORWARD ENOUGH FOR PLACEMENT. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS REMOVED AND UPON REMOVAL THE STENT FELT SLIGHTLY BUCKLED AT THE TIP TO FINGER TOUCH WHILST IT WAS DIFFICULT TO KNOW IF THE ISSUE WAS TO THE STENT OR THE DELIVERY SYSTEM. THE DEVICE WAS INSPECTED PRIOR TO USE. NEGATIVE PREP WAS PERFORMED WHEN I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813686 ↗
• InjuryJun 10, 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 INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED WITH 80% STENOSIS 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE STENT WAS INITIALLY PLACED IN THE LAD ARTERY ACROSS THE CIRCUMFLEX (CX) ARTERY. A SECOND WIRE WAS USED UNDER THE STENT BEFORE DEPLOYMENT TO PROTECT THE CX, WITH ANOTHER WIRE DOWN THE LAD. AFTER DEPLOYMENT, THE CX WIRE WAS REMOVED, AND IT WAS OBSERVED THAT THE STENT STRETCHED AND UNRAVELED, FLOATING OUT OF THE LEFT MAIN ARTERY AND PARTIALLY INTO THE AORTA. A SNARE WAS USED TO RETRIEVE THE ENTIRE DEFORMED STENT. A NEW STENT WAS PLACED IN THE LA, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22173836 ↗
• MalfunctionMay 23, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE 4.0 X 26MM ONYX FRONTIER CORONARY DRUG-ELUTING STENT WAS NOTICED TO BE OFF THE BALLOON WHILE PLACING IT ON THE WIRE. THIS STENT NEVER WENT INSIDE THE PATIENTS BODY. IT WAS ALSO REPORTED THAT THAT A SECOND STENT, A 3.5 X 26 MM ONYX FRONTIER STENT, THE CATHETER WAS KINKED TOWARDS THE END OF THE CATHETER. THE STENT WENT INSIDE THE GUIDE CATHETER BUT NEVER OUTSIDE THE GUIDE CATHETER. WHEN THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER, IT BROKE APART INTO TWO PIECES. NEITHER STENT CATHETER HAD TROUBLE BEING REMOVED FROM THE HOOP. THE LESION BEING TREATED WAS A 100% RIGHT CORONARY ARTERY (RCA) LESION. NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE EVENT. OTHER STENTS WERE PLACED IN THE ARTERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076714 ↗
• MalfunctionApr 22, 2025Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED THAT DURING USE OF ONE ONYX FRONTIER DRUG ELUTING STENT, THE BALLOON WOULD NOT INFLATE INSIDE THE STENT. AN ATTEMPT WAS MADE TO DEPLOY THE STENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH AND THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879871 ↗
• InjuryNov 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED WHEN PULLING BACK FROM THE DISTAL TO MID PART OF THE LESION. THE LESION WAS SEVERELY TORTUOSITY, SEVERELY CALCIFICATION WITH A 90% STENOSIS AND LOCATED IN THE MID-DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLYDEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE STENT WAS SUCCESSFULLY REMOVED USING BALLOON INFLATION. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20755974 ↗
• InjuryDec 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RAC). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL AFTER AN UNSUCCESSFUL SNARE ATTEMPT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18299354 ↗
• InjuryOct 6, 2023Entrapment of Device; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Entrapment of Device; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A CALCIFIED LESION IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT THE STENT WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED STENT IN THE LM THAT HAD ALREADY BEEN POST-DILATED. IT WAS NOTED THAT THE GUIDE CATHETER MAY HAVE BECOME DISENGAGED AS THE STENT WAS ADVANCED INTO THE LM. THE STENT FAILED TO BE DELIVERED AND UPON PULL BACK FROM THE LM, THE STENT DISLODGED INTO THE AORTA. A SNARE WAS USED TO SUCCESSFULLY TO REMOVE THE DISLODGED STENT FROM THE PATIENT. IT WAS NOTED THAT THIS WAS A COMPLEX CASE WITH THE USE OF AN IMPELLA AND ROTOBLADE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17886364 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER DRUG ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND IN THE 2ND DIAGONAL ARTERY. ONE EUPHORA BALLOON AND ONE NC EUPHORA BALLOON WERE ALSO USED FOR PRE DILATATION, ONE NC EUPHORA BALLOON WAS USED FOR POST DILATION. A LAUNCHER GUIDE CATHETER WAS ALSO USED DURING THE PROCEDURE. DURING THE PROCEDURE THE PATIENT SUFFERED FROM ACUTE CLOSURE OF THE 2ND DIAGONAL. NO REFLOW WAS NOTED IN THE DIAGONAL POST LAD STENT DEPLOYMENT. A PLAQUE SHIFT OCCURRED DURING STENT DEPLOYMENT IN LAD. THE EVENT WAS RELATED TO THE ONYX FRONTIER DEVICE: ONYXNG35026UX, LOT# 0011589739. THE ARTERY WAS SUCCESSFULLY REOPENED BY STENTING WITH AN ONYX FRONTIER DRUG ELUTING STENT WHICH WAS IMPLANTED IN THE SIDE BRANCH VIA T-STENTING. A GLYCOPROTEIN 2B3A INFUSION WAS ALSO ADMINISTERED. THE FINAL DIAMETER STENOSIS WAS 10% AND THE FINAL TIMI FLOW WAS 3. THE PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17240009 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 85% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 USED DURING DELIVERY. IT WAS REPORTED THAT A PERFORATION OF THE PROXIMAL LAD OCCURRED IMMEDIATELY AFTER STENT DEPLOYMENT. THE PATIENT DECOMPENSATED QUICKLY AND A NON-MEDTRONIC (MDT) COVERED STENT WAS USED TO SEAL THE PERFORATION. THE PATIENT WAS INTUBATED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED. PERICARDIOCENTESIS WAS ALSO NEEDED. PRIOR TO THE PERFORATION A NON-MDT CORONARY ORBITAL ATHERECTOMY SYSTEM, A NON-MDT SCORING BALLOON AND A NON-MDT NC BALLOON WERE USED WITH NO ISSUES. THE PATIENT LEFT THE THEATRE ROOM ON A VENTILATOR. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Insufficient Information; Perforation

  MAUDE report 15778824 ↗