Onyx Frontier™ ONYXNG25030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000511333), received between Oct 25, 2022 and Sep 28, 2026 — classified as 7 injuries, 6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  A patient suffered from a heart attack and had 3 Onyx Frontier coronary drug eluting stents implanted. Approximately 3 months post procedure the three stents were occluded and the patient suffered from a heart attack. The stents had restenosis. The patient is awaiting a procedure to remove the plaque and open the lumen. No further patient complications were reported.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion; Restenosis

  MAUDE report 50912136 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated; Positioning Problem

  During a procedure an attempt was made to use one Onyx Frontier coronary Drug Eluting Stent when stent dislodgement occurred during removal following failed delivery. The device was inspected with no issues. Negative prep was not performed. The lesion was pre-dilated. The lesion being treated was a mildly tortuous, mildly calcified lesion located in the ostium of the Left Main (LM) Coronary Artery and Circumflex (CX) Artery. The device did pass through a previously-deployed stent. There was resistance encountered when advancing the device, and excessive force was not used during delivery. The stent was being delivered to the lesion site in the proximal CX artery when resistance was encountered. The stent was pulled out, and when it was pulled back it came off the balloon and got stuck in the patient in the LM and aorta. The stent was removed using a snare. No further patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50087362 ↗
• InjuryMar 10, 2026Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT AND ONE NC EUPHORA BALLOON CATHETER, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE TARGET LESION WAS LOCATED IN THE MID OBTUSE MARGINAL (OM) ARTERY WHICH EXHIBITED MILD TORTUOSITY. THE ONYX FRONTIER WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. WHILE TRYING TO DELIVER THE STENT TO THE OM ARTERY, THE STENT GOT CAUGHT (POSSIBLY ON THE WIRE THAT MAY HAVE BEEN THROUGH A STENT STRUT ON THE PROXIMAL LAD ARTERY) AND WAS HALF IN THE AORTA HALF IN THE LEFT MAIN ARTERY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE STENT, AND IT WAS ULTIMATELY RETRIEVED USING A SNARE. ADDITIONALLY, THE NC EUPHORA BALLOON, WAS INTENDED FOR USE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND WAS FOUND TO HAVE A DEFORMED TIP. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558590 ↗
• MalfunctionOct 8, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT COULD NOT CROSS THE LESION, AND ABNORMAL DAMAGE TO THE STENT STRUTS WAS VISUALIZED UPON REMOVAL. A 0.014 NON-MEDTRONIC GUIDE WIRE WAS USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396645 ↗
• InjuryJul 3, 2024Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY (CX). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DEVICE WAS DELIVERED THROUGH AN EXISTING STENT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY TO THE CX ARTERY WHEN IT WAS DISCOVERED THAT THE STENT BEING DELIVERED CAME OFF THE BALLOON. THE DISLODGED STENT WAS REMOVED USING A SNARE.  THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19665708 ↗
• InjuryMay 21, 2024Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Deformation Due to Compressive Stress; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 85% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED 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. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED UP AGAINST THE ARTERY WALL WITH AN ADDITIONAL STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19359234 ↗
• MalfunctionJan 26, 2024Leak/Splash; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT BALLOON LEAKAGE WAS NOTED UPON THE FIRST INFLATION AT 12 ATM FOR STENT DEPLOYMENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585931 ↗
• InjuryDec 19, 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 LESION. IT WAS REPORTED THAT THE STENT CAME OFF OF THE DELIVERY SYSTEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360067 ↗
• MalfunctionSep 28, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DEVICE TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). 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 HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT CAME OFF IN A LAUNCHER GUIDE CATHETER. THE GUIDE CATHETER WAS REMOVED AND THE STENT REMAINED INSIDE THE GUIDE CATHETER. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832638 ↗
• MalfunctionSep 21, 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS NOT REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786894 ↗
• MalfunctionSep 14, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION WITH 80% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.5X12MM NC EUPHORA BALLOON CATHETER. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY.  IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. A 6F EBU 3.5 GUIDE CATHETER WAS ALSO IN USE DURING THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT IS ALIVE WITH INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749822 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A HEAVILY CALCIFIED LESION IN THE MID OBTUSE MARGINAL (OM1). IT WAS REPORTED THAT THE STENTS STRUT BENT WHILE TRYING TO PASS. THE STENT WAS UNABLE TO CROSS THE LESION. THE STENT WAS REMOVED INTACT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459384 ↗
• InjuryOct 25, 2022Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER DRUG ELUTING STENT'S (DES) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE OSTIUM LEFT MAIN CORONARY ARTERY AND THE PROXIMAL DIAGONAL BRANCH. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOR BOTH DEVICES WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY OF THE DEVICES. THE SECOND STENT ONYXNG25030UX (PLI20) PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. ONYXNG25030UX (PLI20) WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. FOR THE FIRST STENT USED, ONYXNG22518UX (PLI10), IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. FOR THE SECOND ONYX FRONTIER DRUG ELUTING STENT, ONYXNG25030UX (PLI20), IT WAS REPORTED THAT WIRE MOVEMENT ISSUES OCCURRED AND THERE WAS POOR GUIDEWIRE MOVEMENT DURING THE PROCEDURE. THE STENTS WERE DEPLOYED WITH A NON MDT WIRE TRAPPED BEHIND THE DEPLOYED ONYX FRONTIER. THE WIRE MOVEMENT ISSUES OCCURRED WITH A NON MDT WIRE WHICH BECAME TRAPPED AGAINST THE LAD TO OSTIUM BEHIND A NON MDT CORONARY DILATION CATHETER WHICH LED TO THE STENT

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665969 ↗