Onyx Frontier™ ONYXNG35022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000511586), received between Nov 21, 2022 and Mar 5, 2026 — classified as 1 death, 9 injuries, 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY, WHICH EXHIBITED SEVERE CALCIFICATION AND HEAVY CALCIUM AT THE LESION. BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. BOTH DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF BOTH DEVICE. THE PROCEDURE WAS INITIALLY PERFORMED VIA THE RADIAL APPROACH. THE LESION WAS PRE-DILATED USING A 2.5X15 SEMI-COMPLIANT BALLOON AND A 4.0X12 SHOCKWAVE BALLOON, WITH MULTIPLE BALLOON INFLATIONS PERFORMED. AN INITIAL ATTEMPT TO DELIVER THE 3.0X26 STENT WAS UNSUCCESSFUL AS THE STENT DID NOT CROSS THE LESION. A GUIDELINER WAS USED AND THE STENT WOULD STILL NOT CROSS THE LESION. UPON REMOVAL OF THE STENT BALLOON, IT WAS OBSERVED THAT THE 3.0X26 STENT WAS NO LONGER ATTACHED TO THE BALLOON CATHETER. THE DISLODGED STENT WAS SNARED AND REMAINED IN THE RIGHT BRACHIAL ARTERY AS THE STENT WOULD NOT GO PAST THIS POINT. THE PHYSICIAN THEN SWITCHED TO A GROIN APPROACH, USING AN NC 3.5X27 BALLOON AT THE TARGET LESION AND A 7 FRENCH GUIDELINER. AN ATT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517723 ↗
• MalfunctionAug 28, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, STENT DISLODGMENT OCCURRED DURING DELIVERY TO THE LESION. DURING ATTEMPT TO ADVANCE THE DEVICE THROUGH THE GUIDE CATHETER, THE DEVICE WAS UNABLE TO EXIT THE GUIDE CATHETER AND GOT CAUGHT ON ONE EUPHORA BALLOON IN THE RAMUS. A NON-MEDTRONIC GUIDEWIRE WAS ALSO PRESENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION BEING TREATED WAS NON-TORTUOUS AND NON-CALCIFIED LOCATED INTHE PROXIMAL CIRCUMFLEX (CX). THE LESION WAS NOT PRE-DILATED. THE DEVICE 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 DISLODGED STENT WAS REMOVED WITH SOME RESISTANCE NOTED. NO EXCESSIVE FORCE WAS USED AND NO INTERVENTION WAS REQUIRED FOR REMOVAL. A DIFFERENT STENT WAS USED TO STENT THE TARGET LESION IN THE CX. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910994 ↗
• MalfunctionAug 25, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT DEFORMED IN VIVO DURING POSITIONING. THE STENT STRUT WAS BENT WHEN ATTEMPTED TO ADVANCE THE STENT IN THE LESION. THE LESION WAS PRE-DILATED WITH AN NC BALLOON. AFTER THE STENT COULD NOT BE ADVANCED, THE DEVICE WAS REMOVED AND NOTICED THE STENT STRUT WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIZE ONYX STENT. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION EXHIBITED SEVERE TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS INSPECTED PRIOR TO USE 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PROCEDURE WAS COMPLETED WITH ONE 3.5X18MM 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 22891160 ↗
• InjuryJul 7, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS DISLODGED IN VIVO DURING DELIVERY TO THE LESION. THE STENT WAS INITIALLY INSERTED INTO THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WHICH HAD 60% STENOSIS AND MODERATE CALCIFICATION AND WAS SNAGGED ON A PREVIOUSLY DEPLOYED 30X22MM ONYX FRONTIER DRUG ELUTING STENT. THE STENT WAS REMOVED, AND A NON-COMPLIANT (NC) BALLOON WAS USED TO PREPARE THE LESION. THE STENT WAS REINSERTED AND WAS STRIPPED FROM THE DELIVERY SYSTEM BALLOON AT THE LESION. THE DELIVERY SYSTEM WAS REMOVED, LEAVING THE STENT UNDEPLOYED IN THE RCA. THE UNDEPLOYED STENT WAS SUBSEQUENTLY REMOVED USING A SNARE. 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410068 ↗
• MalfunctionJun 3, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE 3.50 X 22MM ONYX FRONTIER CORONARY DRUG ELUTING STENT BALLOON BURST. THE BALLOON BURST OCCURRED DURING THE FIRST INFLATION WHEN NOMINAL INFLATION PRESSURE WAS APPLIED. THE DEVICE WAS NOT MOVED OR REPOSITIONED IN THE LESION WHILE INFLATED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE LESION BEING TREATED WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS ALSO REPORTED THAT ANOTHER 3.50 X 22MM ONYX FRONTIER STENT FAILED TO CROSS AND WAS NOT USED INSIDE THE PATIENT. THERE WERE NO ISSUES NOTED WHEN REMOVING THIS DEVICE FROM THE HOOP/TRAY. THIS DEVICE WAS INSPECTED BEFORE USE AND NEGATIVE PREP WAS PERFORMED 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 22130039 ↗
• InjuryJan 2, 2025Leak/Splash; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Split, Cut or Torn; Leak/Splash; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE DELIVERY OF AN ONYX FRONTIER STENT TO A LESION, THE STENT BECAME DISLODGED. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

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

  MAUDE report 21054788 ↗
• InjuryAug 28, 2024Device 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 SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. SHOCKWAVE AND PRE-DILATION OF THE LESION WERE PERFORMED BEFORE THE STENT ENTERED THE BODY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL, FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED AND WAS LEFT IN THE ARTERY. ANOTHER STENT WAS PLACED IN THE ARTERY TO SMASH THE DISLODGED STENT AGAINST THE ARTERY WALL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 20083999 ↗
• InjuryJun 11, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS DEPLOYED IN DISTAL VESSEL. IT WAS STATED THAT A DEVICE DETACHMENT OCCURRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513004 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION HAD IN-STENT RESTENOSIS (ISR). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS 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 REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE STENT WAS DISLODGED WHILE ATTEMPTING TO PULL IT BACK AFTER IT WOULD NOT CROSS THE PRIMARY LESION. NO ISSUES WERE NOTED AND WHILE ATTEMPTING TO PULL THE STENT BACK NOT A LOT OF TENSION OR PULL WAS NOTED. THE STENT BECAME DISLODGED AND WENT TO THE INTERNAL ILIAC ARTERY. THE VASCULAR SURGERY AND OTHER INTERVENTIONAL CARDIOLOGIST (IC) OPERATORS WERE CONTACTED, AND IT WAS DECIDED TO LEAVE THE STENT. TWO DAYS LATER THE PATIENT NEEDED THE CIRCUMFLEX ARTERY TREATED, THEREFORE, A FEMORAL APPROACH WAS USED, AND THE DISLODGED STENT WAS SNARED FROM INTERNAL ILIAC ARTERY. THE PATIENT

  Patient problems: Insufficient Information

  MAUDE report 19060364 ↗
• InjuryMar 4, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. IT WAS STATED THAT THE DISLODGED STENT WAS CRUSHED AND TRAPPED WITH A NON-MEDTRONIC STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18826347 ↗
• MalfunctionAug 18, 2023Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION DURING A CARDIAC CATHETERIZATION IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT BALLOON POPPED WHEN PLACING THE STENT AT THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570652 ↗
• DeathAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 90-95% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED AT 16 ATM DURING BALLOON INFLATION. IT WAS DETAILED THAT THE BALLOON WAS DELIVERED TO THE SITE OF THE HEAVY CALCIFIED LESION IN THE PROXIMAL LAD. AFTER THE FIRST INFLATION THE BALLOON RUPTURED AND BECAME CAUGHT OR HUNG UP AT THE LESION SITE OF INFLATION. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THERE WERE REMOVAL DIFFICULTIES AS THE BALLOON APPEARED TO BE CAUGHT ON THE CALCIUM, DESPITE SEVERAL ATTEMPT TO PULL THE CATHETER DELIVERY SYSTEM AND BALLOON BACK INTO THE GUIDE CATHETER. DUE TO 8/10 CHEST PAIN, A BALLOON PUMP WAS INSERTED, WITH IMPROVEMENT IN CHEST PAIN TO 4/10. THE PATIENT REMAINED HEMODYNAMICALLY STAB

  Patient problems: Insufficient Information

  MAUDE report 17562525 ↗
• InjuryJan 19, 2023Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% OF STENOSIS, IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUED 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 AT 18ATM. IT WAS DETAILED THAT THE STENT BALLOON WOULD NOT FULLY EXPAND WITH DEPLOYMENT, AND ONLY THE PROXIMAL EDGE PARTIALLY EXPANDED. THE STENT BALLOON WAS REMOVED FULLY INTACT. A 3.5 X 20MM NC EUPHORA EASILY CROSSED THE STENT AND WAS USED TO POST-DILATE THE STENT. THE NC EUPHORA WAS INFLATED TO MAX CAPACITY OF 20 ATM AND THE STENT WAS FULLY EXPANDED. THE PATIENT WENT HOME WITHOUT INCIDENT AND IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16204679 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONYX FRONTIER CORONARY DRUG ELUTING STENT IN A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH 85-90% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT 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 AFTER THE STENT WAS DEPLOYMENT IN THE LESION A PERFORATION WAS NOTICED. TWO NON-MEDTRONIC COVERED STENTS WERE USED TO SEAL THE PERFORATION. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Perforation

  MAUDE report 15832707 ↗