Onyx Frontier™ ONYXNG27515UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000511388), received between May 17, 2023 and Oct 20, 2025 — classified as 1 death, 4 injuries, 4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS NOTED TO BE DEFORMED WHEN IT WAS REMOVED FROM THE PATIENT. THE LESION BEING TREATED WAS MODERATELY CALCIFIED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH 80% STENOSIS. THE LESION WAS PRE-DILATED WITH ONE NON-MEDTRONIC BALLOON. ONE NON-MEDTRONIC KISSING BALLOON WAS USED IN THE CX AND ANOTHER NON-MEDTRONIC KISSING BALLOON WAS USED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) HOWEVER THE DEVICE WAS UNABLE TO CROSS. POST KISSING USING THE NON-MEDTRONIC BALLOONS RESULTED IN DISSECTIONS IN THE PROXIMAL CX AND LAD. THE DEVICE DID NOT PLAY A PART IN THE DISSECTIONS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DISSECTIONS WERE STENTED. THE CX WAS STENTED WITH A DIFFERENT SIZE ONYX WITHOUT ISSUE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE PATIENT IS ALIVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334800 ↗
• InjuryJun 6, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FRACTURED AFTER DEPLOYMENT. IT WAS STATED THAT NOTHING DETACHED, IT JUST FRACTURED. THE LESION BEING TREATED WAS A NON TORTUOUS, MILDLY CALCIFIED LESION IN THE MID CIRCUMFLEX ARTERY (CX). THE DEVICE WAS INSPECTED BEFORE USE 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 AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22156590 ↗
• InjuryMar 14, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) DISLODGED DURING DELIVERY TO THE LESION. DURING AN ATTEMPT TO CROSS THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), THE STENT CAME OFF THE BALLOON AND INTO THE LEFT MAIN (LM) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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. MULTIPLE INFLATIONS WERE PERFORMED TO CRUSH THE DISLODGED STENT AGAINST THE WALL IN THE LM AND THE STENT WAS IMPLANTED IN THE LM. ONE 3.0X38MM ONYX DES WAS PLACED IN THE PROXIMAL LAD, AND ONE 2.75X18MM ONYX DES WAS PLACED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY AFTER THE DISLODGED STENT WAS CRUSHED IN THE LM. IT WAS NOTED THAT SHOCKWAVE THERAPY WAS ALSO USED ON THE PROXIMAL LAD FOLLOWED BY INTRAVASCULAR ULTRASOUND AFTER THE ISSUE OCCURRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21604128 ↗
• InjuryNov 15, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS BEING TREATED FOR AN ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 2.5X20MM EUPHORA BALLOON, AND A 2.75MM NON-MEDTRONIC NC BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT COULD NOT CROSS THE LESION OF THE TOTAL OCCLUSION. UPON REMOVAL, THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS NOT REMOVED. IT WAS POSSIBLE TO OPEN THE DISLODGED STENT IN THE OSTIUM OF THE RCA USING A 2.75X12MM EUPHORA BALLOON. A MEDTRONIC 6F LAUNCHER GUIDE CATHETER AND A MEDTRONIC TELESCOPE GUIDE EXTENSION CATHETER WERE ALSO USED DURING THE PROCEDURE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 20693001 ↗
• InjuryAug 12, 2024Burst Container or Vessel; Entrapment of Device; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Burst Container or Vessel; Entrapment of Device; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 99% STENOSIS LOCATED IN THE DISTAL SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. 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. IT WAS REPORTED THAT THERE WERE INFLATION DIFFICULTIES NOTED DURING STENT DEPLOYMENT. IT WAS ALSO REPORTED THAT THE BALLOON BURST AT 8ATM DURING STENT DEPLOYMENT. THE ISSUES OCCURRED ON THE FIRST INFLATION. IT WAS STATED THERE WERE DIFFICULTIES REMOVING THE DEVICE FOLLOWING STENT DEPLOYMENT AND THAT THE BALLOON PARTIALLY INFLATED AND PARTIALLY DEPLOYED THE STENT, HOWEVER THE BALLOON WAS STILL HUNG UP IN THE STENT DISTALLY. ANOTHER BALLOON WAS USED TO POST DILATE THE STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19960205 ↗
• MalfunctionJun 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE PHYSICIAN WAS ABLE TO GET THE BALLOON BACK INSIDE THE DISLODGED STENT AND DEPLOY IT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510298 ↗
• MalfunctionNov 28, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION WITH 99% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT STRUT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH A NON-MEDTRONIC DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18214958 ↗
• MalfunctionNov 14, 2023Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) DEVICE AND ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION. THE DEVICES WERE REMOVED FROM THE PACKAGING AS PER IFU, WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED, WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED AS PER IFU, WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED WHEN ADVANCING THE TELESCOPE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE ONYX FRONTIER DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT WOULD NOT PASS THROUGH THE TELESCOPE DEVICE. THE STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS STRIPPED OFF THE DELIVERY SYSTEM OUTSIDE THE BODY IN CO-PILOT HEMOSTAT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133178 ↗
• DeathMay 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING THE REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT CAME OFF THE CATHETER WHILE IN THE ARTERY. THE DISLODGED STENT WAS NOT REMOVED. IT WAS CRUSHED IN PLACE WITH ANOTHER STENT. THE PATIENT WAS REPORTED TO HAVE DECEASED.

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

  MAUDE report 16944196 ↗