Onyx Frontier™ ONYXNG35030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000511609), received between Nov 15, 2022 and Mar 3, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT CAME OFF THE BALLOON FOLLOWING A FAILED DELIVERY. THE TARGET LESION WAS CALCIFIED LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495284 ↗
• MalfunctionNov 27, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A PATIENT HAD ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) FIVE DAYS POST ITS EXPIRY DATE. THE PATIENT WAS REPORTED TO BE STABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663871 ↗
• InjuryAug 10, 2025Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation; Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT A BURST/LEAK OCCURRED. THE STENT BALLOON BURST/LEAKED DURING STENT DEPLOYMENT AT AN INFLATION PRESSURE OF 4-6 ATMOSPHERES. THE LESION BEING TREATED WAS THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, WHICH EXHIBITED MILD TORTUOSITY, NON-CALCIFIED WITH 80% STENOSIS. 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. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22767949 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED TO HOSPITAL WITH A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). EMERGENT FILMS REVEALED 100% STENOSIS OF THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 3.0X15MM EUPHORA CORONARY BALLOON. ONE 3.5X30MM ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS DEPLOYED TO 12 ATM FOR 30 SECONDS WITH GOOD EXPANSION NOTED. THERE WAS NO RESIDUAL STENOSIS AND TIMI III FLOW. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY (DAPT). ON A CLINIC VISIT AT A LATER DATE, A ROUTINE EKG WAS PERFORMED WHICH SHOWED ST ELEVATION. THE PATIENT REPORTED INTERMITTENT FEELINGS OF CHEST UNEASINESS. THE PATIENT WAS COMPLAINT WITH DAPT. THE PATIENT WAS TAKEN FOR AN URGENT CATHETERIZATION, AND FILMS SHOWED 100% STENOSIS WITH HEAVY THROMBUS AT THE PROXIMAL EDGE OF THE PREVIOUSLY DEPLOYED ONYX FRONTIER STENT IN THE MID RCA. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED THAT THE STENT WAS WELL APPOSED AND FULLY EXPANDED. THERE APPEARED TO BE MODERATE/SEVERE PLAQUE AT THE DISTAL EDGE OF THE STENT. A 3.0X38MM ONYX FRONTIER STENT WAS PLACED AT THE DISTAL PORTION OF THE MID RCA. INTRACORONARY ANTIPLATELET DRUG INTEGRILIN WAS GIVEN WITH NO CHANGE IN THE THROMBUS. ANOTHER 3.0X26MM ON

  Patient problems: Chest Pain; Insufficient Information; Non specific EKG/ECG Changes; Obstruction/Occlusion; Stenosis; Thrombosis/Thrombus

  MAUDE report 20663549 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE CIRCUMFLEX (CX) ARTERY. THE VESSELS HAD SEVERE CORONARY DISEASE WITH SEVERE 90% STENOSIS. THE DEVICES WERE INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED ON BOTH THE LAD AND CX STENTS. ASPIRATION THROMBECTOMY WAS REQUIRED AS WELL AS ADDITIONAL STENTING OF THE CX. INITIALLY HEPARIN 3700UNITS WAS GIVEN FOLLOWED BY AN ADDITIONAL DOES OF 3000UNITS TO A THERAPEUTIC ACT OF 305. THE PATIENT WAS LOADED WITH PLAVIX 600MG. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 19490345 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE CIRCUMFLEX (CX) ARTERY. THE VESSELS HAD SEVERE CORONARY DISEASE WITH SEVERE 90% STENOSIS. THE DEVICES WERE INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED ON BOTH THE LAD AND CX STENTS. ASPIRATION THROMBECTOMY WAS REQUIRED AS WELL AS ADDITIONAL STENTING OF THE CX. INITIALLY HEPARIN 3700UNITS WAS GIVEN FOLLOWED BY AN ADDITIONAL DOES OF 3000UNITS TO A THERAPEUTIC ACT OF 305. THE PATIENT WAS LOADED WITH PLAVIX 600MG. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 19482749 ↗
• MalfunctionApr 30, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210942 ↗
• MalfunctionJul 18, 2023Leak/Splash; Improper or Incorrect Procedure or Method; Material Deformation; Leak/Splash; Improper or Incorrect Procedure or Method; 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 90-95% STENOSIS IN THE PROXIMAL OBTUSE MARGINAL (OM) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT DEFORMATION TO THE STENT DELIVERY SYSTEM OCCURRED AS BLOOD CAME BACK THROUGH THE NON-MEDTRONIC INDEFLATOR WHEN NEGATIVE PREP WAS PERFORMED. IT WAS LATER DETAILED THAT NEGATIVE PREP WAS NOT PERFORMED ON THE ONYX FRONTIER BEFORE USE IN THE PATIENT. NEGATIVE PREP WAS PERFORMED AFTER THE DEVICE WAS INSERTED INTO THE PATIENT. THE DEVICE WAS NOT MOVED OR REPOSITIONED IN THE LESION WHILE INFLATED OR WHEN NEGATIVE PREP WAS ATTEMPTED. NO LEAK WAS NOTED UNTIL NEGATIVE PREP WAS PERFORMED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341660 ↗
• MalfunctionApr 27, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA DEVICE AND TWO ONYX FRONTIER DEVICES TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE FIRST ONYX FRONTIER DEVICE WAS INSPECTED WITH ISSUES NOTED, IT WAS REPORTED THAT THE STENT STRUT WAS RAISED AFTER RESISTANCE WAS FELT WHILE INSERTING THE DEVICE THROUGH A TELESCOPE DEVICE. THE NC EUPHORA DEVICE AND THE SECOND ONYX FRONTIER DEVICE USED DURING THE PROCEDURE WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON ALL THREE DEVICES WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING ALL THREE DEVICES HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE NC EUPHORA DEVICE WAS DEFORMED AND KINKED AND THAT STENT DEFORMED IN VIVO DURING POSITIONING OCCURRED WHILE USING THE TWO ONYX FRONTIER DEVICES. THE PROCEDURE WAS COMPLETED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823299 ↗
• MalfunctionApr 27, 2023Difficult to Insert; Device Damaged by Another Device; Material Deformation; Difficult to Insert; Device Damaged by Another Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA DEVICE AND TWO ONYX FRONTIER DEVICES TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE FIRST ONYX FRONTIER DEVICE WAS INSPECTED WITH ISSUES NOTED, IT WAS REPORTED THAT THE STENT STRUT WAS RAISED AFTER RESISTANCE WAS FELT WHILE INSERTING THE DEVICE THROUGH A TELESCOPE DEVICE. THE NC EUPHORA DEVICE AND THE SECOND ONYX FRONTIER DEVICE USED DURING THE PROCEDURE WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON ALL THREE DEVICES WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING ALL THREE DEVICES HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE NC EUPHORA DEVICE WAS DEFORMED AND KINKED AND THAT STENT DEFORMED IN VIVO DURING POSITIONING OCCURRED WHILE USING THE TWO ONYX FRONTIER DEVICES. THE PROCEDURE WAS COMPLETED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823276 ↗
• MalfunctionNov 15, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY AND OBTUSE MARGINAL (OM) WITH 90% OF STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE LESION WAS PRE-TREATED USING 3 PASSES OF 1.5 BURR ROTABLATOR. THE LESION WAS THEN PRE-DILATED USING A 3.0 X 20MM NC EUPHORA AND A 3.25 X 6MM NON MEDTRONIC CUTTING BALLOON. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION.THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. THERE IS NO COMPLAINT AGAINST THE NC EUPHORA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797089 ↗