Onyx Frontier™ ONYXNG45012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000511722), received between Jan 22, 2024 and Feb 12, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS APPROXIMATELY 15 DAYS EXPIRED WHEN IT WAS IMPLANTED IN A LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE 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 21362646 ↗
• 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 20381377 ↗
• 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 20145016 ↗
• 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 RE-VASCULARIZATION, 1 ONYX FRONTIER STENT, 3 NC EUPHORA BALLOONS,1 EUPHORA BALLOON AND 1 LAUNCHER GUIDE CATHETER WERE USED. THE PATIE

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

  MAUDE report 18552442 ↗