Onyx Frontier™ ONYXNG25026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000511326), received between Oct 14, 2022 and May 18, 2026 — classified as 1 death, 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Premature Activation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO. THE DEVICE WAS ATTEMPTED TO BE USED IN THE PATIENT, THEN REMOVED AND THE DEVICE LOOKED OKAY. THE DEVICE WAS THEN INSERTED FOR THE SECOND TIME AND WHEN THE DEVICE WAS REMOVED AGAIN, THE STENT FELT EXPANDED MORE ON THE DISTAL END RATHER THAN THE PROXIMAL END. IT WAS NOT POSSIBLE TO LOAD THE STENT INTO THE COPILOT EASILY. IT FELT LIKE THE STENT WAS NOT CRIMPED ENTIRELY ON THE BALLOON AND THE STENT WAS DESCRIBED TO BE "WINGED". THE DEVICE WAS NOT HOOKED UP TO A INDEFLATOR. THE LESION INTENDED TO BE TREATED WAS THE DISTAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING, THE PACKAGING WAS INTACT AND UNDAMAGED PRIOR TO OPENING. THE DEVICE PROTECTIVE SHEATH WAS REMOVED PER IFU. THERE WAS NO GAP NOTICEABLE BETWEEN THE RETRACTABLE SHEATH AND THE TIP WHEN DEVICE WAS REMOVED FROM THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE STENT WAS INSPECTED AFTER REMOVAL OF THE PROTECTIVE SHEATH AND THE STRUTS LOOKED SMOOTH, NO DEVICE ISSUES WERE NOTED. THE RED CLIP WAS IN THE CORRECT POSITION WHEN THE EXPOS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200982 ↗
• MalfunctionFeb 13, 2026Fracture; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS, BOTH DEVICES DETACHED IN VIVO DURING DELIVERY THROUGH A LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WHICH WAS HEAVILY CALCIFIED. THE PROXIMAL CX ARTERY WAS THEN BALLOONED WITH A 4.0X15MM NC EUPHORA AND THE STENT DEVICES PASSED SUCCESSFULLY. THE DISTAL OBTUSE MARGINAL (OM) ARTERY WAS SUCCESSFULLY STENTED WITH NO ISSUES. THE TARGET LESION WAS LOCATED IN THE DISTAL OM ARTERY WHICH EXHIBITED MODERATE TORTUOSITY, SEVERE CALCIFICATION AND CHRONIC TOTAL OCCLUSION (CTO) 100%. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. THE DETACHED PORTIONS OF THE DEVICES DO NOT REMAIN IN THE PATIENT AND WERE REMOVED THROUGH THE GUIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330503 ↗
• InjuryMay 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DELIVERY OF THE ONYX FRONTIER DRUG ELUTING STENT TO THE DISTAL RIGHT CORONARY ARTERY, STENT DISLODGEMENT OCCURRED. THE STENT WAS SUBSEQUENTLY BALLOONED IN THE VESSEL, BUT NOT AT THE LOCATION OF THE LESION. THE LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED SEGMENT OF THE ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED PRIOR TO THE EVENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT, AND NO EXCESSIVE FORCE WAS USED. THE DISLODGED STENT WAS NOT REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22113122 ↗
• MalfunctionMay 28, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A CORONARY INTERVENTION, ONE ONYX FRONTIER DRUG-ELUTING STENT WAS ADVANCED INTO THE PATIENT BUT FAILED TO ADVANCE WITHIN THE VESSEL, RESULTING IN VIVO STENT DEFORMATION DURING POSITIONING. THE DEVICE WAS SUBSEQUENTLY REMOVED AND INSPECTED, REVEALING A FRAYED SECTION IN THE MID-STENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES OBSERVED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094933 ↗
• InjuryMay 15, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING THE DELIVERY OF THE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO THE LESION, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO A MILDLY TORTUOUS AND MILDLY CALCIFIED LESION IN THE LEFT MAIN (LM) AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY EXHIBITING 90% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE LESION WAS PRE-DILATED, AND THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT MAIN (LM) ARTERY FOLLOWING SUCCESSFUL BALLOON DILATION. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO DELIVER A 2.5X26 MM STENT THROUGH THE DEPLOYED STENT INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, AND THE STENT COULD NOT BE DELIVERED. UPON WITHDRAWING THE DELIVERY SYSTEM, IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON. IMAGING REVEALED THE STENT HAD DISLODGED AND WAS POSITIONED BETWEEN THE LM AND THE AORTA. AN ATTEMPT TO RETRIEVE THE STENT WAS UNSUCCESSFUL. THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL WITHIN THE LM USING A BALLOON. INTRAVASCULAR ULTRAS

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

  MAUDE report 22029157 ↗
• MalfunctionJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO THE LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE STENT DISLODGED INSIDE A TELESCOPE GUIDE EXTENSION CATHETER (GEC). WHILE ADVANCING THE STENT THROUGH THE GEC INTO THE LAD, THE STENT WAS NOT SEEN ON THE DELIVERY BALLOON, AND IT WAS REALIZED THAT THE STENT HAD DISLODGED INSIDE THE GEC. THE GEC, ALONG WITH THE DISLODGED STENT, STENT DELIVERY SYSTEM, AND THE WIRE WERE REMOVED FROM THE PATIENT. THE STENT WAS SUCCESSFULLY REMOVED WHILE INSIDE THE GEC. THE ONYX FRONTIER DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167208 ↗
• InjuryDec 9, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE 2.5X26MM ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS BEING USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE DISTAL SUPERIOR OBTUSE MARGINAL (OM). A 7F GUIDE CATHETER WAS ENGAGED IN THE LEFT MAIN (LM) AND MULTIPLE NON-MEDTRONIC GUIDEWIRES WERE ADVANCED. THE SUPERIOR OM2 BRANCH WAS PRE-DILATED SERIALLY WITH A 2.0X20MM EUPHORA BALLOON. ONE 2.5X18MM ONYX FRONTIER STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE LESION. THEN THE 2.5X26MM ONYX FRONTIER WAS ATTEMPTED TO BE ADVANCED BUT COULD NOT BE ADVANCED FULLY TO THE TARGET LESION, THEREFORE THE DEVICE WAS BEING REMOVED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. UPON PULLING THE STENT BACK TO THE GUIDE CATHETER THE STENT DISLODGED OFF THE BALLOON INTO THE LM EXTENDING INTO THE OSTIAL CIRCUMFLEX (CX) AREA. RESISTANCE WAS NOT FELT WHEN PULLING BACK THE STENT. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DECIDED THAT IT WAS SAFEST TO DEPLOY THE STENT AT THE LOCATION OF THE DISLODGEMENT GIVEN THE AM

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

  MAUDE report 20877443 ↗
• InjuryApr 16, 2024Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Remove; 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 SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE RCA OSTIUM WAS DIFFICULT TO ENGAGE WITH GUIDE CATHETER. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE DEVICE WOULD NOT DELIVER TO THE CALCIFIED PROXIMAL RCA. THE DEVICE WAS THEN STRETCHED AND PULLED OFF THE BALLOON COMING BACK INTO THE GUIDE CATHETER. THE STENT FELL OFF THE SYSTEM FULLY IN THE FOREARM, AND WAS RETRIEVED THROUGH THE SHEATH. THE PROCEDURE WAS THEN FINISHED. A NON-MEDTRONIC STENT WAS USED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19113886 ↗
• MalfunctionApr 3, 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, SEVERELY CALCIFIED LESION WITH 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT AFTER THE STENT FAILED TO CROSS THE LESION, THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE STENT WAS NOT INTACT AS EXPECTED, AND THE STENT WAS DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS LOCATED INSIDE OF THE NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC), AND THE STENT WAS MANUALLY RECOVERED UPON REMOVAL OF THE GEC. IT WAS ALSO REPORTED THAT STENT DEFORMATION OCCURRED UPON THE REMOVAL PROCESS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031438 ↗
• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE LAUNCHER GUIDE CATHETER, ONE EUPHORA BALLOON CATHETER, FIVE NC EUPHORA BALLOON CATHETERS, AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED FROM A SPONTANEOUS MYOCARDIAL INFARCTION (MI) AND CARDIAC ARREST / SUDDEN CARDIAC DEATH. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE, HAD EATEN DINNER AND EVERYTHING WAS NORMAL WHEN SUDDENLY THE PATIENT COLLAPSED ON THE GROUND. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF CHEST PAIN, DIAPHORESIS, NAUSEA, OR VOMITING. ADVANCED LIFE SAVING MEASURES WERE UTILIZED. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND A FAMILY MEMBER TRIED TO DO SOME MOUTH-TO-MOUTH UNTIL THE AMBULANCE ARRIVED. WHEN THE AMBULANCE ARRIVED, THEY DETECTED ELECTROMECHANICAL DISSOCIATION (EMD) AND STARTED CARDIOPULMONARY RESUSCITATION (CPR) FOR 30 MINUTES BEFORE THE PATIENT ARRIVED TO THE EMERGENCY ROOM (ER). ADDITIONAL CPR WAS PERFORMED, HOWEVER, THIS WAS UNSUCCESSFUL IN OBTAINING BLOOD PRESSURE. TH

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 18947774 ↗
• MalfunctionJan 8, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS/POSITION THE LESION AND STENT DEFORMATION OCCURRED. IT WAS DETAILED THAT STENT DEFORMATION WAS NOTICED AFTER THE STENT WAS REMOVED FOLLOWING THE FAILURE OF THE STENT TO CROSS THE LESION. IT IS UNKNOWN IF STENT DEFORMATION OCCURRED PRIOR TO USE OR DURING USE AS THE DEVICE WAS NOT INSPECTED UNTIL END OF PROCEDURE. ANOTHER 2.5X15MM STENT WAS USED TO TREAT THE LESION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462499 ↗
• MalfunctionJun 30, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE CATHETER OF THE DEVICE DETACHED, CRACKED, OR FRACTURED DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237626 ↗
• MalfunctionJun 7, 2023Burst Container or Vessel; Fracture; Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Burst Container or Vessel; Fracture; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THERE WAS A STENT ISSUE AND A BALLOON BURST/LEAK OCCURRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077206 ↗
• MalfunctionOct 14, 2022Fracture; Material Deformation; Fracture; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 100% STENOSIS, LOCATED IN THE MID DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PREFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. THE CAUSATIVE DEVICE WAS A POST DILATION BALLOON. A POTENTIAL STENT FRACTURE OCCURRED. THE ONYX FRONTIER STENT WAS POST-DILATED WITH A 3.0 NON-COMPLIANT (NC) BALLOON, A 3.5 NC BALLOON AND A 4.0 NC BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605193 ↗