Onyx Frontier™ ONYXNG40012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000511647), received between Nov 7, 2022 and Feb 21, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WERE INFLATION DIFFICULTIES DURING STENT DEPLOYMENT OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT. THE LESION BEING TREATED HAD 100% STENOSIS AND WAS IN THE MID LEFT ANTERIOR DESCENDING (LAD) 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE STENT WAS NOT IMPLANTED AND DID NOT NEED TO BE POST-DILATED WITH ANOTHER BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431177 ↗
• InjuryMay 17, 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, AND ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 70% STENOSIS IN THE OSTIUM/PROXIMAL RIGHT CORONARY ARTERY (RCA). TAKE-OFF OF THE OSTIUM WAS NOT TYPICAL. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE ONYX FRONTIER DID NOT DEVICE PASS THROUGH A PREVIOUSLY DEPLOYED STENT, AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE ONYX FRONTIER STENT DISLODGED DURING DELIVERY TO THE LESION. AN ATTEMPT TO DELIVER THE STENT WAS UNSUCCESSFUL. WHEN WITHDRAWING THE STENT DISLODGED. THE STENT WAS REMOVED SUCCESSFULLY USING A SNARE DEVICE, AND EVERYTHING WAS REMOVED INCLUDING THE GUIDE. ALL NEW EQUIPMENT WAS RE-INSERTED, AND A NON-MEDTRONIC STENT WAS DELIVERED WITHOUT A PROBLEM. IT WAS ALSO REPORTED THAT THE TIP OF THE NC EUPHORA DEVICE FRACTURED. THE TIP WAS STILL ATTACHED TO BALLOON, AND THE ISSUE WAS NOTICED BEFORE INSERTING THE DEVICE INTO THE BODY OR GUIDE CATHETER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE NC EUPHORA. THERE WERE NO ISSUES NOTED WHEN

  Patient problems: Insufficient Information

  MAUDE report 19340424 ↗
• InjuryApr 11, 2024Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  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 MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 4.0MM NON-MEDTRONIC INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON AND A 2.5MM BALLOON. 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 THE BALLOON FAILED TO EXPAND UNDER THE STENT. IT WAS DETAILED THAT AT FIRST A LONGER STENT WAS ATTEMPTED TO BE USED BUT WAS UNABLE TO CROSS THE LESION. THEREFORE, TWO SHORTER STENTS WERE TO BE USED. THE ONYX FRONTIER STENT WAS THE FIRST STENT TO BE PLACED BUT DURING DEPLOYMENT THE DISTAL PART OF THE STENT DEPLOYED, BUT THE BALLOON WOULD NOT FULLY INFLATE AT THE PROXIMAL END. IT WAS STATED THAT IT WAS LIKE THE BALLOON HAD RUPTURED. THE NON-MEDTRONIC INFLATION DEVICE WAS EVALUATED AND TRIED MULTIPLE TIM ES WITH NO SUCCESS. THE STENT BALLOON WAS REMOVED, AND OTHER BALLOONS WERE USED TO INFLATE THE STENT TO A FULLY OPPOSED LEVEL WITHIN THE ARTERY

  Patient problems: Insufficient Information

  MAUDE report 19085928 ↗
• InjuryNov 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH 90% STENOSIS. THE PATIENT HAD A PREVIOUSLY DEPLOYED NON-MEDTRONIC (MDT) STENT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND ANOTHER NON-MDT STENT IMPLANTED IN THE LEFT MAIN (LM) INTO THE PROXIMAL CX IN 2021. THE PATIENT DEVELOPED STENT RESTENOSIS ON THE OSTIAL/PROXIMAL CX WHICH WAS THE INTENDED LESION TO TREAT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A 3.5 AND 4.0 NON COMPLIANT BALLOONS. THE DEVICE DID PASS 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 FAILED DELIVERY. AN ATTEMPT WAS MADE TO PASS A NON-MDT GUIDE EXTENSION CATHETER (GEC) TO THE AREA OF RESTENOSIS, HOWEVER, THE GEC WOULD NOT ADVANCE INTO THE CX. THE INTENTION WAS TO UNSHEATHE THE ONYX FRONTIER STENT WITH THE NON-MDT GEC AS THERE WAS CONCERNS REGARDING THE ABILITY TO ADVANCE THE STENT INSIDE THE PREVIOUSLY DEPLOYE

  Patient problems: Insufficient Information

  MAUDE report 15743015 ↗