Onyx Frontier™ ONYXNG22526UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000511234), received between Sep 13, 2022 and Mar 13, 2026 — classified as 2 injuries, 6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. THE STENT BECAME UNMOORED FROM THE STENT DELIVERY BALLOON WHILE BEING REMOVED FROM THE VESSEL. ATTEMPTS TO RETHREAD THE STENT DELIVERY BALLOON THROUGH THE DISLODGED STENT WERE UNSUCCESSFUL. THE STENT DELIVERY BALLOON WAS REMOVED AND FURTHER ATTEMPTS TO TRAVERSE THE PROXIMAL PORTION OF THE STENT WITH A 1.5 X 20MM NON MEDTRONIC BALLOON AND A 1.25 X 10MM SPRINTER LEGEND BALLOON WERE ALSO UNSUCCESSFUL. HIGH MAGNIFICATION IMAGING REVEALED THAT THE PROXIMAL PORTION OF THE STENT APPEARED NONLINEAR AND IN AN S CONFIGURATION, INDICATING STENT DEFORMATION. THE NON MEDTRONIC WIRE WAS FOUND TO BE ADHERENT TO THE UNDEPLOYED STENT IN A MECHANICAL LOCK POSITION. THE GUIDING CATHETER, WIRE, AND UNDEPLOYED STENT WERE REMOVED AS A SINGLE UNIT, RESULTING IN THE STENT AND WIRE ABUTTING NEXT TO THE RIGHT RADIAL SHEATH IN THE PROXIMAL FOREARM. THE CASE AND IMAGES WERE REVIEWED BY A VASCULAR SURGERY TEAM, AND THE PATIENT WAS TRANSFERRED TO A TERTIARY CARE FACILITY FOR FURTHER MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588759 ↗
• MalfunctionAug 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS STATED THAT THE STENT CAME OFF THE BALLOON AND LODGED IN THE CORONARY ARTERY. THE DISLODGED STENT WAS REMOVED. NO HARM WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063487 ↗
• MalfunctionApr 16, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID OBTUSE MARGINAL (OM) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH A 2.25X26MM STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113797 ↗
• InjuryJul 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE DISTAL 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. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DETAILED THAT THE DISLODGED STENT WAS CRUSHED AGAINST THE ARTERY WALL PROXIMAL TO THE TARGET LESION WITH ANOTHER ONYX FRONTIER STENT. A 22.5X18MM ONYX FRONTIER STENT WAS THEN CROSSED AND SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 17279511 ↗
• MalfunctionApr 19, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION WITH 85% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE TO THE LESION. EXCESSIVE FORCE WAS NOT USED. WHEN INITIALLY TRYING TO CROSS THE LESION, IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. IT IS UNKNOWN IF THERE WAS ANY STENT DEFORMATION DURING ATTEMPTS TO INSERT THE DEVICE INTO THE GUIDE CATHETER. IT WAS CONFIRMED THAT THE STENT DID NOT DEFORM DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16767653 ↗
• MalfunctionJan 31, 2023Device 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, MODERATELY CALCIFIED LESION, WITH 90% STENOSIS, IN THE OSTIUM AND DISTAL LEFT MAIN (LM) CORONARY 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 PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS ALSO REPORTED THAT STENT DISLODGEMENT OCCURRED IN VITRO. THE LESION WAS TREATED WITH ROTATIONAL ABLATION USING A NON-MEDTRONIC (MDT) 1.75MM BURR, AS WELL AS A 2.0 X 20MM NON-MDT BALLOON AND A 2.5 X 15MM NON-MDT NC BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272028 ↗
• MalfunctionJan 3, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE THREE ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY CALCIFIED LESION IN THE MID/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SECOND DEVICE (ONYXNG25015UX). EXCESSIVE FORCE WAS USED DURING DELIVERY OF ALL DEVICES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION FOR THE FIRST TWO DEVICE (ONYXNG25008UX ) & (ONYXNG25015UX). THE DISLODGED STENTS WERE NOT REMOVED. IT WAS POSSIBLE TO GET A BALLOON CATHETER THROUGH BOTH STENTS AND THE STENTS WERE DEPLOYED. SEVERAL BALLOONS WERE USED. FOR THE THIRD DEVICE (ONYXNG22526UX), IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085245 ↗
• MalfunctionSep 13, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 95% STENOSIS IN THE MID DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED NON-MEDTRONIC STENT IN THE PROXIMAL RCA. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, HOWEVER, EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS ALSO DETAILED THAT THE STRUT DAMAGED INSIDE A NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED USING A 2.25 X18MM AND 2.25 X 08MM ONYX FRONTIER DEVICES. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15408202 ↗