Onyx Frontier™ ONYXNG22538UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000511265), received between Jan 17, 2023 and Sep 3, 2025 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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.

• MalfunctionSep 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION WAS OBSERVED. IT WAS REPORTED THAT THE STENT WAS BLENDED/FOLDED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, SEVERELY CALCIFIED AND LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT INSPECTED PRIOR TO USE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952299 ↗
• MalfunctionAug 29, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO OR AT THE LESION, STENT DISLODGEMENT OCCURRED. THE DISLODGED STENT WAS REMOVED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922315 ↗
• InjuryJun 27, 2025Entrapment of Device; Migration or Expulsion of Device; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem; Entrapment of Device; Migration or Expulsion of Device; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FAILED TO CROSS THE LESION. THE LESION BEING TREATED WAS NON-TORTUOUS, MILDLY CALCIFIED AND LOCATED IN THE OSTIUM LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A EUPHORA BALLOON, BUT THE VESSEL/LESION WAS NOT PREPPED FOR CALCIUM PRIOR TO STENTING. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DEVICE DELIVERY. IT WAS DETAILED THAT THE STENT BECAME STUCK ON THE STEPDOWN OF THE NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) AND GUIDE. THE NON-MEDTRONIC GUIDEWIRE WAS TRAPPED IN THE STENT STRUT WHEN THE STENT WAS DEPLOYED. THERE WAS THEN DIFFICULTY REMOVING THE NON-MEDTRONIC GEC, GUIDEWIRE, AND GUIDE. AFTER REMOVAL OF THE NON-MEDTRONIC GEC AND GUIDEWIRE, THE STENT WAS OBSERVED TO BE HANGING IN THE AORTA. THE STENT WAS THEN CRUSHED INTO THE LM USING A NON-MEDTRONIC BALLOON. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22343519 ↗
• MalfunctionApr 28, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916630 ↗
• InjuryMar 27, 2025Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT AND DETACHED DURING REMOVAL. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. THERE WAS A PRIOR STENT LOCATED IN THE LEFT MAIN (LM), THAT ALSO PROTRUDED INTO THE AORTA. THE LESION BEING TREATED WAS THE HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. THERE WAS DIFFICULTY EXPERIENCED ADVANCING THE STENT PAST THE OSTIUM LM CORONARY ARTERY, AND AN ATTEMPT WAS MADE TO FORCIBLY DELIVER THE STENT FURTHER INTO THE VESSEL. THE STENT BECAME LODGED IN THE LM STENT AS WELL AS A CALCIFIED SEGMENT. UPON ATTEMPTED RETRIEVAL OF THE STENT WITH A SNARE, THE STENT UNRAVELED AND BROKE, LEAVING A PORTION OF THE STENT DANGLING IN THE LM. A SECOND ATTEMPT WAS MADE TO RETRIEVE THE REST OF THE DETACHED STENT, AND THE STENT BROKE AGAIN, LEAVING A SMALLER PORTION OF THE STENT DANGLING IN THE LM. THE FINAL PORTION OF THE DETACHED STENT WAS FINALLY SUCCESSFULLY RETRIEVED USING A GUIDE CATHETER WITH A LARGER INNER DIAMETER. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPL

  Patient problems: Insufficient Information

  MAUDE report 21705695 ↗
• InjuryNov 11, 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 (DES) TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 50% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS IN ATRIAL FIBRILLATION AT THE START OF THE PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED MULTIPLE TIMES WITH A 1.5X12MM NON-MEDTRONIC (MDT) BALLOON AND A 2.25X20MM NON-MDT BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. A LEFT FEMORAL ARTERY APPROACH WAS USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. AN ATTEMPT WAS MADE TO DELIVER THE STENT DISTALLY, BUT THERE WAS TROUBLE DELIVERING THE STENT. THE STENT WAS BROUGHT BACK TO THE GUIDE AND WAS GOING TO BE TAKEN BACK DOWN, BUT IT WAS FELT THAT THE STENT CAME OFF THE BALLOON A LITTLE. WHEN THE DEVICE WAS EXAMINED, IT WAS POSSIBLE TO TELL THAT THE STENT WAS A LITTLE OFF THE BALLOON DISTALLY. THE DECISION WAS MADE TO INFLATE THE STENT BALLOON AT THE CURRENT LOCATION. THE STENT BALLOON WAS DEPLOYED AT 10 A

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

  MAUDE report 20652157 ↗
• InjuryJul 22, 2024Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID MAMMARY GRAFT. THE TARGET LESION WAS THE NATIVE LEFT ANTERIOR DESCENDING (LAD) ARTERY, DISTAL TO THE INTERNAL MAMMARY ARTERY (IMA) INSERTION. THE LEFT INTERNAL MAMMARY ARTERY (LIMA) WAS VERY TORTUOUS. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT TWO SHORTER STENTS WERE SUCCESSFULLY DEPLOYED TO THE NATIVE LAD. IT WAS BELIEVED THAT THE 2.25X38 ONYX FRONTIER STENT WOULD GO TO THE NATIVE LAD, HOWEVER, STENT DISLODGEMENT OCCURRED. THERE WAS A GUIDE CATHETER INDUCED DISSECTION PROXIMAL TO THE STENT DISLODGEMENT, WHICH OCCURRED BEFORE THE STENT DISLODGEMENT. AN ATTEMPT WAS MADE TO RETRIEVE THE DISLODGED STENT BUT WAS UNSUCCESSFUL. EVENTUALLY, WIRE POSITION WAS LOST, AND ACCESS WAS SWITCHED FROM THE RIGHT RADIAL TO A FEMORAL APPROACH. IT WAS THEN POSSIBLE TO WIRE THE IMA AND DEPLOY STENTS OVER THE DISLOD

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

  MAUDE report 19791066 ↗
• MalfunctionNov 23, 2023Fracture; Device Dislodged or Dislocated; Material Deformation; Fracture; Device Dislodged or Dislocated; Material Deformation

  IT WAS INTENDED TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT (DES) TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON AS THE STYLET WAS BEING REMOVED. THE STENT WAS FRACTURED AND CRACKED. IT CANNOT BE CONFIRMED IF THIS OCCURRED DURING REMOVAL OF THE STYLET. IT WAS NOT REALIZED THAT THE STENT WAS ABSENT UNTIL ATTEMPTING TO DEPLOY THE DELIVERY SYSTEM. THE BALLOON FROM THE STENT DELIVERY SYSTEM WAS INFLATED AND DEFLATED, THEN THE BALLOON WAS PULLED BACK. A CORONARY ANGIOGRAM WAS PERFORMED TO ASSESS THE STENT IMPLANTATION. IT WAS AT THIS POINT IT WAS NOTED THAT THERE WAS NO STENT DEPLOYMENT OR IMPLANTATION. THE STENT WAS FOUND ON THE STYLET AND HAD NEVER BEEN INTRODUCED INTO THE PATIENT¿S VASCULATURE. NO PATIENT INJURY WAS REPORTED. NO COMPLICATIONS OR ADVERSE EFFECTS WERE REPORTED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18198290 ↗
• InjuryJul 26, 2023Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID OBTUSE MARGINAL (OM) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 DURING DELIVERY. IT WAS REPORTED THAT THE ONYX FRONTIER STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT FOLLOWING THE FAILED DELIVERY ATTEMPT THE STENT WAS BEING PULLED BACK INTO A NON-MEDTRONIC GUIDE EXTENSION CATHETER WHEN THE STENT DISLODGED. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS DEPLOYED IN THE OM ARTERY WITH THE USE OF BALLOONS. NO FURTHER PATIENT INJURY WAS REPORTED.

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

  MAUDE report 17400426 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH ISSUES. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING NEGATIVE PREP, WHICH WAS BEING PERFORMED INSIDE THE PATIENT. THE DEVICE WAS DRY PREPPED AND WHEN THE OPERATOR PULLED NEGATIVE ON THE INFLATION DEVICE THERE WAS ASPIRATION OF BLOOD. THE ISSUE OCCURRED BEFORE THE FIRST INFLATION OF THE DEVICE. IT WAS DETAILED THAT THE RUPTURED BALLOON WAS FROM THE FACTORY. THE PATIENT WAS NOT HARMED. A REPLACEMENT STENT HAD TO BE OPENED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794047 ↗
• MalfunctionFeb 15, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL/OSTIUM LEFT MAIN (LM) CORONARY ARTERY, LEFT ANTERIOR DESCENDING (LAD) ARTERY AND CIRCUMFLEX (CX) ARTERY. 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. THE PROCEDURE WAS COMPLETED WITH A NEW SAME SIZE ONYX FRONTIER STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377595 ↗
• InjuryJan 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED IN THE VESSEL AND AN ADDITIONAL STENT WAS PLACED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16183797 ↗