Onyx Frontier™ ONYXNG30015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000511470), received between Aug 3, 2022 and Mar 4, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Burst Container or Vessel; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT A BALLOON BURST / PUNCTURE OCCURRED DURING STENT DEPLOYMENT. THE BALLOON BURST AT 6 ATM ON THE FIRST INFLATION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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. THE LESION BEING TREATED WAS A NON TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505088 ↗
• MalfunctionDec 11, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE DEVICE WAS INSERTED INTO THE PATIENT BUT A MALFUNCTION WITH THE CATHETER OCCURRED WHICH LED TO THE STENT NOT BEING DEPLOYED. THE STENT FAILED DUE TO AN ISSUE WITH THE CONNECTION BETWEEN SECTIONS OF THE STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776758 ↗
• InjurySep 12, 2025Material Deformation; Material Deformation

  DURING THE INITIAL PROCEDURE THE PATIENT PRESENTED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION MANIFESTED BY A SEVERE 90% STENOSIS INVOLVING THE DISTAL LEFT MAIN CORONARY ARTERY EXTENDING INTO THE PROXIMAL SEGMENTS OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX CORONARY ARTERIES. THREE STENTS WERE IMPLANTED: A 3.0 X 15MM ONYX FRONTIER STENT, A 4.0 X 18 MM ONYX FRONTIER STENT, AND A 4.5 X 18MM ONYX FRONTIER STENT IMPLANTED. A 0.014 NON-MEDTRONIC WIRE WAS ADVANCED AND PLACED WITHIN THE DISTAL SEGMENT OF THE LAD. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE 1ST OBTUSE MARGINAL BRANCH. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM PRIMARY ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY EXTENDING INTO THE PROXIMAL LAD. AN IVUS CATHETER WAS THEN ADVANCED AND IVUS ASSESSMENT OF THE LEFT MAIN CORONARY ARTERY AND LAD WAS OBTAINED. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM FURTHER ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY INTO THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. AN ONYX FRONTIER 3 X 15 MM DRUG-ELUTING STENT WAS THEN ADVANCED AND PLACED WITHIN THE PROXIMAL LEFT CIRCUMFLEX CORONARY EXT

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Ischemia; Myocardial Infarction; Restenosis

  MAUDE report 23036012 ↗
• MalfunctionJul 17, 2025Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE STENT CAME OFF THE BALLOON, HOWEVER IT WAS REWIRED, INFLATED AND IMPLANTED. REMOVAL DIFFICULTIES WERE ALSO ENCOUNTERED DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENTS VASCULATURE DUE TO THE CALCIUM PRESENT. THE SDS WAS REMOVED WITH NO INTERVENTION REQUIRED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529065 ↗
• InjuryApr 28, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE STENT DISLODGED DURING ADVANCEMENT INTO A LESION INSIDE A PREVIOUSLY IMPLANTED STENT. THE LESION WAS LOCATED PROXIMALLY IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY, SEVERE CALCIFICATION AND 70% STENOSIS. THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION, AND IT WAS BELIEVED TO HAVE BEEN CAUGHT ON THE PREVIOUS STENT. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED USING A SNARE WHILE IT WAS STILL ON THE GUIDE WIRE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT HOWEVER NO EXCESSIVE FORCE WAS USED DURING DELIVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Insufficient Information; Pain

  MAUDE report 21916374 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE OF ONE ONYX FRONTIER DRUG ELUTING STENT, THE STENT DISLODGED FROM THE BALLOON WHEN THE DEVICE HAD PASSED THROUGH THE HEMOSTATIC VALVE AND INTO THE GUIDE CATHETER. THE STENT DID NOT DISLODGE IN THE PATIENTS VASCULATURE. THE BALLOON WAS NOT INFLATED PRIOR TO STENT DISLODGEMENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH AND THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879815 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE OF ONE ONYX FRONTIER DRUG ELUTING STENT, THE STENT DISLODGED FROM THE BALLOON WHEN THE DEVICE HAD PASSED THROUGH THE NON MEDTRONIC HEMOSTATIC VALVE AND INTO THE GUIDE CATHETER. THE STENT DID NOT DISLODGE IN THE PATIENTS VASCULATURE. THE BALLOON WAS NOT INFLATED PRIOR TO STENT DISLODGEMENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH AND THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879703 ↗
• MalfunctionSep 16, 2024

  DEVICE PACKAGING OPENED. THE STENT DELIVERY SYSTEM FOR IMPLANTATION WAS PREPARED. THE PHYSICIAN SAW THAT THE STENT ITSELF WAS FRACTURED BEFORE PROCEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223834 ↗
• InjuryFeb 20, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID AND PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY FOR BOTH STENTS. BOTH STENTS WERE REMOVED USING A 25MM GOOSENECK SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18737066 ↗
• MalfunctionJul 13, 2023Entrapment of Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Entrapment of Device; 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 MILDLY TORTUOUS, NON-CALCIFIED LESION WITH 86% STENOSIS IN THE MID 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 PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT BECAME STUCK IN THE TELESCOPE 6F GUIDE EXTENSION CATHETER. IT WAS DETAILED THAT AN INITIAL DELIVERY OF THE STENT WAS ATTEMPTED WITHOUT THE USE OF THE TELESCOPE. IT WAS SUSPECTED THAT THE STENT MAY HAVE BEEN DAMAGE WHEN PUSHING AGAINST THE PREVIOUSLY DEPLOYED STENT THAT WAS PLACED MORE PROXIMAL TO THE SECONDARY LESION BEING TREATED. THE DISLODGED STENT WAS REMOVED TOGETHER WITH THE TELESCOPE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320015 ↗
• InjuryFeb 8, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE ONYX FRONTIER STENT WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOR THE ONYX FRONTIER STENT PRIOR TO ADVANCING THE DEVICE TO THE LESION WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE ONYX FRONTIER STENT DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOTED WHEN ADVANCING THE ONYX FRONTIER STENT BUT EXCESSIVE FORCE WAS NOT USED. THE TELESCOPE GEC WAS INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS STATED THAT IT WAS ATTEMPTED TO DELIVER THE ONYX FRONTIER STENT THROUGH A LESION WITH EXTREME TORTUOSITY AND CALCIFICATION USING THE TELESCOPE. IT WAS BELIEVED THAT THE STENT CAME OFF THE DELIVERY SYSTEM WHEN PULLING THE UNDEPLOYED STENT INTO THE TELESCOPE. THE DISLODGED STENT WAS REMOVED F ROM PATIENT B

  Patient problems: Insufficient Information

  MAUDE report 16320632 ↗
• MalfunctionAug 3, 2022Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT AFTER RESISTANCE WAS MET THE STENT WAS REMOVED AND A STENT STRUT WAS NOTED TO BE LIFTED. THE PHYSICIAN COMPLETED THE PROCEDURE USING THE SAME SIZE DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156492 ↗