Onyx Frontier™ ONYXNG35018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000511579), received between Jan 5, 2023 and Sep 28, 2026 — classified as 9 injuries, 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  A patient suffered from a heart attack and had 3 Onyx Frontier coronary drug eluting stents implanted. Approximately 3 months post procedure the three stents were occluded and the patient suffered from a heart attack. The stents had restenosis. The patient is awaiting a procedure to remove the plaque and open the lumen. No further patient complications were reported.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion; Restenosis

  MAUDE report 50912131 ↗
• InjuryMay 1, 2026Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WHEN THE DEVICES BECAME DISLODGED IN-VIVO DURING DELIVERY TO/AT LESION. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE LESION BEING TREATED WAS A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES, AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE STENTS WERE NOT REMOVED FROM THE PATIENT. WITH BOTH STENTS, THE STENT WAS RE-WIRED AND DEPLOYED USING MULTIPLE BALLOONS AND ADDITIONAL SAME SIZE STENTS. NEW STENTS OF THE SAME SIZE WERE PLACED. PATIENT NOW HAS DOUBLE LAYERED STENTS IN 2 PORTIONS OF THE RCA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25055965 ↗
• MalfunctionJul 31, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE USE OF AN ONYX FRONTIER DRUG-ELUTING STENT, THE BALLOON RUPTURED DURING DEPLOYMENT AT AN INFLATION PRESSURE OF 8 ATM. THE LESION WAS ENCOUNTERED IN THE MID SEGMENT OF THE RIGHT CORONARY ARTERY, MODERATELY TORTUOSITY, SEVERE CALCIFICATION AND A CHRONIC TOTAL OCCLUSION (100% LESION STENOSIS) WERE PRESENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DEVICE INSPECTION PRIOR TO USE AND NEGATIVE PREP WERE PERFORMED WITH NO ISSUES FOUND. THE LESION WAS PRE-DILATED PRIOR TO STENT DEPLOYMENT. THE STENT WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682995 ↗
• MalfunctionJun 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DETACHED FROM THE BALLOON UNEXPANDED AND PREMATURELY IN THE LEFT MAIN (LM). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157584 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FELL OFF THE BALLOON. 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 22104458 ↗
• InjuryOct 7, 2024Adverse 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 MAIN CORONARY ARTERY (LMCA) AND IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE INDEX PROCEDURE 6 NC EUPHORA BALLOONS AND 1 LAUNCHER GUIDE CATHETER WERE ALSO USED. APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE THE PATIENT UNDERWENT A CLINICALLY DRIVEN TARGET VESSEL REVASCULARIZATION OF THE LCMA AND THE CX TO TREAT IN STENT RESTENOSIS DURING WHICH ONE ONYX FRONTIER STENT WAS IMPLANTED. DURING THIS REVASCULARIZATION 3 NC EUPHORA BALLOONS,1 EUPHORA BALLOON AND 1 LAUNCHER GUIDE CATHETER WERE ALSO USED. APPROXIMATELY 16 MONTHS POST THE INDEX PROCEDURE AND 8 MONTHS POST THE REVASCULARIZATION PROCEDURE, THE PATIENT SUFFERED FROM INTERMITTENT CHEST PAIN. THE PATIENT WENT TO EMERGENCY DEPARTMENT AFTER THE CHEST PAIN WORSENED AND UNDERWENT CARDIAC CATHETERIZATION. IT WAS STATED THAT THERE WAS POSSIBLE RESTENOSIS. STENT THROMBOSIS WAS CONFIRMED BY ANGIO IN THE ONYX FRONTIER STENT. THE EVENT WAS TREATED WITH HOSPITALIZATION AND A SURGICAL PROCEDURE - CARDIAC CATHETERIZATION USED FOR DIAGNOSTIC PURPOSES. THE PATIENT HAS NOT RECOVERED. THE PATIENT WAS TAKING DUAL ANTIPLATELET THERAPY WITHIN 24

  Patient problems: Chest Pain; Insufficient Information; Stenosis; Thrombosis/Thrombus

  MAUDE report 20381354 ↗
• InjurySep 5, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO NC EUPHORA BALLOONS AND ONE EUPHORA BALLOON WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE THE PATIENT UNDERWENT A CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION PROCEDURE DURING WHICH TWO ONYX FRONTIER DES WERE IMPLANTED IN THE MID LAD. THREE NC EUPHORA BALLOONS AND ONE LAUNCHER GUIDE CATHETER WERE ALSO USED DURING THIS REVASCULARIZATION PROCEDURE. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE AND 11 MONTHS POST THE REVASCULARIZATION PROCEDURE, THE PATIENT SUFFERED FROM A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND CHEST PAIN. THE PATIENT WENT TO THE EMERGENCY ROOM FOR SUBSTERNAL CHEST PAIN THAT RAISED TO THE LEFT SHOULDER, SOME SHORTNESS OF BREATH AND PALPITATIONS. THE PATIENT WAS NOTED TO BE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR) AND WITH INCREASING TROPONINS. THE PATIENT WAS DIAGNOSED WITH A TYPE 2 SPONTANEOUS MYOCARDIAL INFARCTION (MI) WHICH WAS SECONDARY TO AN ISCHEMIC IMBALANCE. THE MI OCCURRED IN THE TERRITORY OF THE TARGET VESSEL. THE EVENT WAS TR EATED WITH

  Patient problems: Arrhythmia; Atrial Fibrillation; Cardiac Enzyme Elevation; Chest Pain; Dyspnea; Insufficient Information; Ischemia; Myocardial Infarction

  MAUDE report 20144996 ↗
• MalfunctionMay 7, 2024Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 DELIVERY TO LESION. THE STENT ENTANGLED AT ENTRY TO THE GUIDE EXTENSION CATHETER AND DISLODGED. THE DISLODGED STENT WAS REMOVED AS THE STENT WAS TRAPPED IN THE GUIDE AND THE GUIDE WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257304 ↗
• InjuryJan 22, 2024Adverse 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 MAIN CORONARY ARTERY (LMCA) AND IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE INDEX PROCEDURE 6 NC EUPHORA BALLOONS AND 1 LAUNCHER GUIDE CATHETER WERE ALSO USED. THERE WERE NO ISSUES NOTED WITH THE NC EUPHORA BALLOONS AND LAUNCHER GUIDE CATHETER USED DURING THE INDEX PROCEDURE. APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED A SPONTANEOUS ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT PRESENTED TO THE HOSPITAL WITH 3 DAYS OF STUTTERING SUBSTERNAL CHEST PRESSURE THAT BECAME CONSTANT, RADIATING FROM THE RIGHT TO LEFT SHOULDER. THE AE WAS ASSOCIATED WITH A MYOCARDIAL INFARCTION (MI) AND WAS CLASSIFIED AS A SPONTANEOUS MI IN THE TERRITORY OF THE TARGET VESSEL. IT WAS STATED THAT THE MI WAS RELATED TO TO DEFINITE STENT THROMBOSIS IN BOTH STENTS. IN STENT RESTENOSIS WAS ALSO NOTED IN BOTH STENTS. THE EVENT WAS TREATED WITH A CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION OF THE LMCA AND THE CIRCUMFLEX ARTERY (CX). DURING THE REVASCULARIZATION, 1 ONYX FRONTIER STENT, 3 NC EUPHORA BALLOONS,1 EUPHORA BALLOON AND 1 LAUNCHER GUIDE CATHETER WERE USED. THE PATIEN

  Patient problems: Chest Pain; Insufficient Information; Myocardial Infarction; Stenosis; Thrombosis/Thrombus

  MAUDE report 18552676 ↗
• InjuryDec 19, 2023Burst Container or Vessel; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION WITH 95% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE. NEGATIVE PREP WAS PERFORMED. THE LESION WAS PRE-DILATED WITH A EUPHORA DEVICE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. IT WAS DETAILED AFTER STENT DEPLOYMENT, THE STENT BALLOON WAS MOVED MORE PROXIMALLY AND RE-INFLATED. DURING THAT SECOND INFLATION AT 16ATM THE BALLOON RUPTURED. IT WAS FELT THAT THE BALLOON GOT CAUGHT ON THE STENT AND WAS PERFORATED. DURING AN ATTEMPT TO REMOVE THE BALLOON, THE PROXIMAL PORTION OF THE BALLOON WAS CAUGHT ON THE STENT AND WAS SHEERED OFF IN THE PATIENTS VESSEL. IT WAS DETAILED THAT ANOTHER STENT WAS USED TO TACK UP THAT PIECE OF THE BALLOON AGAINST THE VESSEL WALL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18353879 ↗
• MalfunctionJul 5, 2023Fracture; Difficult to Insert; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Fracture; Difficult to Insert; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON-CALCIFIED, NON-TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). 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. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THERE WAS POOR GUIDEWIRE MOVEMENT DURING THE PROCEDURE. THE DEVICE FELT LIKE IT BENT/KINKED WHILE ADVANCING THE DEVICE AND UPON REMOVING THE DEVICE, THE STENT CRACKED. THE DEVICE WAS ABLE TO BE REMOVED AND NO PORTION OF THE DEVICE REMAINED IN THE PATIENT. A SECOND STENT ADVANCED PERFECTLY WITH NO ISSUE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258382 ↗
• MalfunctionJun 7, 2023Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL 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. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM DEFORMED AT THE CATHETER. IT WAS DESCRIBED AS A CHALLENGING CASE. REMOVAL DIFFICULTIES WERE ENCOUNTERED PRIOR TO STENT DEPLOYMENT. MULTIPLE ATTEMPTS WERE MADE TO PLACE THE STENT THROUGH THE GUIDE CATHETER. IT WAS FELT THAT THIS MANIPULATION DAMAGED THE STENT CATHETER. IT WAS REMOVED AND DETERMINED THAT THE DISTAL END OF THE STENT CATHETER WAS BROKEN. IT WAS DECIDED TO NOT INTERVENE ON THE VESSEL. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082931 ↗
• InjuryMar 10, 2023Burst Container or Vessel; Inflation Problem; Activation, Positioning or Separation Problem; Burst Container or Vessel; Inflation Problem; Activation, Positioning or Separation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.5X12MM AND A 3.0X15MM NON-MEDTRONIC DEVICES. THE ONYX FRONTIER DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. DURING STENT DEPLOYMENT, IT WAS REPORTED THAT A BALLOON BURST OCCURRED ON THE FIRST INFLATION BELOW NOMINAL PRESSURE AT 6 ATM. THE STENT HAD PARTIALLY EXPANDED. A 3.0X15 NON-MEDTRONIC SEMI-COMPLIANT BALLOON CATHETER WAS USED TO RE-CROSS THE STENT. A 4.0X15MM NON-MEDTRONIC NON-COMPLIANT BALLOON WAS USED TO CROSS AND FULLY EXPAND THE PARTIALLY DEPLOYED STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16522179 ↗
• MalfunctionJan 12, 2023Burst Container or Vessel; Inflation Problem; Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn; Burst Container or Vessel; Inflation Problem; Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT STATED THAT THIS WAS AN ACUTE MYOCARDIAL INFARCTION CASE. DURING THE PROCEDURE THE CIRCUMFLEX HAD BEEN STENTED BUT PLAQUE HAD SHIFTED TO THE LAD. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT. IT WAS ALSO REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK WAS ENCOUNTERED DURING STENT DEPLOYMENT AND IT WAS DETAILED THAT THE BURST/LEAK/RUPTURE OCCURRED AT THE CATHETER, CONTRAST WAS LEAKING OUT OF STENT DELIVERY CATHETER AND NOT INFLATING THE STENT BALLOON. THE ONYX FRONTIER STENT WAS ADVANCED AND PLACED IN POSITION FOR INFLATION, HOWEVER, WHEN ATTEMPTING TO INFLATE THE STENT BALLOON TO DEPLOY THE STENT IT WAS CLEAR THAT THE BALLOON WAS NOT EXPANDING. USING THE INFLATION DEVICE, THE BALLOON ATM WAS INCREASED AND THEN WAS SWITCHED OUT FOR A HIGHER PRESSURE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146743 ↗
• InjuryJan 5, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT CAME OUT OF THE PROXIMAL RCA WHILE THE BALLOON WAS BEING INFLATED. THE STENT WAS PARTIALLY DEPLOYED, BUT OUT OF THE RCA. THE WIRE WAS STILL IN PLACE. IT WAS NOT POSSIBLE TO BRING THE STENT BACK INTO THE 6F GUIDE OR 6F RADIAL SHEATH DUE TO THE SIZE. RIGHT FEMORAL ACCESS WAS OBTAINED AND AN 8F SHEATH WAS USED. IT WAS THEN POSSIBLE TO WIRE THE STENT IN THE RIGHT ARM VIA THE RIGHT GROIN APPROACH. USING A BALLOON PARTIAL INFLATED WITHIN THE STENT, THE STENT WAS SUCCESSFULLY BROUGHT BACK INTO THE 8F GUIDE AND OUT OF THE 8F SHEATH. A SNARE WAS NOT USED. A 3.5 X 26MM STENT WAS THEN DEPLOYED WITHOUT INCIDENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16100988 ↗