Onyx Frontier™ ONYXNG40022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000511678), received between Aug 16, 2022 and May 18, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Fracture; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN THE DEVICE DETACHED, CRACKED OR FRACTURED AT THE BALLOON DURING DELIVERY THROUGH THE VESSEL. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE LESION INTENDED TO BE TREATED WAS A MODERATELY TORTUOUS, NON-CALCIFIED LESION WITH 100% STENOSIS LOCATED IN THE PROXIMAL/OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). WHEN THE STENT WAS BEING PLACED AT THE LESION IT WAS NOTED THAT THE BALLOON WAS SLIPPING AND IN ORDER TO PREVENT A FULL DETACHMENT, THE STENT WAS DEPLOYED IN THE PROXIMAL RCA BUT DID NOT COVER THE INTENDED LESION IN THE OSTIUM RCA. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO ATTEMPT WAS MADE TO REMOVE THE DETACHED PORTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25200175 ↗
• MalfunctionDec 22, 2025Inflation Problem; Leak/Splash; Material Deformation; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING THE DEPLOYMENT OF ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT. THE LESION BEING TREATED WAS NON-TORTUOUS, MILDLY CALCIFIED WITH 80% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) 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 2.75 MM NC BALLOON. 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. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED WITH NO VISIBLE INTRALUMINAL CALCIUM. DURING BALLOON INFLATION, DIFFICULTIES WERE ENCOUNTERED AS THE STENT BALLOON WOULD NOT INFLATE ABOVE 2 ATM INITIALLY. IT WAS BELIEVED THAT THERE WAS A HOLE IN THE BALLOON. THE STENT BEGAN EXPANDING AT THE EDGES BEFORE ACHIEVING FULL EXPANSION. PRESSURE WAS CONTINUOUSLY APPLIED AND THE STENT WAS EXPANDED ENOUGH TO REMOVE THE STENT DELIVERY SYSTEM. THE STENT WAS POST-DILATED WITH A 4.0 NC BALLOON AND THE STENT EXPANDED FULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863768 ↗
• MalfunctionNov 5, 2024Fracture; Detachment of Device or Device Component; Positioning Problem; Fracture; Detachment of Device or Device Component; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION WITH 99% STENOSIS IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE CULPRIT LESION HAD TIMI FLOW III, AND THE LESION WAS LOCATED AT THE BEND. THE DISTAL RCA WAS 90% STENOSED WITH TIMI FLOW II. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. THE STENT WAS REMOVED WITHOUT BEING DEPLOYED. IT WAS ALSO REPORTED THAT AFTER THE DEVICE WAS REMOVED FROM THE PATIENT IT WAS NOTED THAT THE WIRE WAS BROKE. THE BREAK OCCURRED DISTAL TO THE STENT. NOTHING WAS LEFT INSIDE THE PATIENT. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609374 ↗
• InjuryMar 27, 2023Fracture; Fracture

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT A STENT FRACTURE OCCURRED AND THE PATIENT HAD A CARDIAC ARREST AS A RESULT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 16618160 ↗
• InjuryDec 5, 2022Burst Container or Vessel; Fracture; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Fracture; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE PATIENT WAS UNDER GOING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). IT WAS REPORTED THAT THE ONYX FRONTIER CATHETER DETACHED, CRACKED, FRANCTURED. THE STENT WAS DEPLOYED HOWEVER THE CATHETER HAD BROKEN OFF AND HAD CAUSED AN OBSTRUCTION. THE PART THAT BROKE OFF HAD TO BE RETRIEVED. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 15913398 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PREFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO EXCESSIVE FORCE USED DURING THE DELIVERY OF THE DEVICE. IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. IT WAS DETAILED THAT BEFORE THE CASE, AN IVUS DEVICE WAS USED AND THE VESSEL WAS DETERMINED TO BE A 4.0 VESSEL. THE ONYX FRONTIER STENT WAS DEPLOYED AND IT WAS REPORTED THAT BLUSHING WAS SEEN AROUND THE VESSEL INDICATING THERE WAS A PERFORATION. IT WAS NOTED THAT THE PATIENT WAS STABLE. IT WAS DETAILED THAT THE BALLOON WAS KEPT INFLATED BEFORE A COVERED STENT WAS PUT IN PLACE. AN ECHOCARDIOGRAM DETERMINED THAT EVERYTHING LOOKED OKAY AND THE PATIENT DID FINE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Perforation

  MAUDE report 15713896 ↗
• MalfunctionAug 16, 2022Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LESION WITH 90% STENOSIS IN THE OSTIUM OF THE SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 THE BALLOON BURST DURING STENT DEPLOYMENT AT 22 ATM DURING THE FIRST INFLATION. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233680 ↗