Onyx Frontier™ ONYXNG27518UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000511395), received between Nov 2, 2022 and Jan 14, 2026 — classified as 2 deaths, 5 injuries, 2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathJan 14, 2026Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PCI PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED FROM ITS BALLOON. ANOTHER BALLOON WAS POSITIONED WITHIN THE STENT AND THE STENT WAS DEPLOYED. THE PATIENT EXPIRED ON THE SAME DAY.

  Patient problems: Insufficient Information; Myocardial Infarction

  MAUDE report 24070922 ↗
• MalfunctionApr 24, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT ONE 2.75MM ONYX FRONTIER CORONARY DRUG ELUTING STENT APPEARED MORE LIKE A 3.25MM STENT AFTER DEPLOYMENT. THE STENT WAS PLACED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A 2.5X12MM EUPHORA BALLOON. THE 2.75MM ONYX FRONTIER STENT WAS DEPLOYED AT NOMINAL PRESSURE OF 12 ATM. THE STENT APPEARED TO BE LARGER THAN THE DESCRIBED 2.75MM ON THE PACKAGING. AN ADDITIONAL 2.0X26MM ONYX FRONTIER STENT WAS PLACED DISTALLY TO THE MID LAD, AND A 2.5X18MM ONYX FRONTIER STENT WAS PLACED PROXIMAL TO THE MID LAD 2.75MM ONYX FRONTIER CORONARY DRUG ELUTING STENT. THE LESION WAS POST DILATED WITH A 2.75X12MM NC EUPHORA BALLOON. THE STENTS ARE OPEN, AND THE PATIENT IS DOING FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898136 ↗
• InjuryApr 1, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED AFTER REMOVAL FROM THE PATIENT. THE LESION BEING TREATED WAS THE OSTIUM OF THE RIGHT POSTERIOR DESCENDING (R-PDA) 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 ENCOUNTERED WHEN ADVANCING THE DEVICE IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. AFTER RESISTANCE WAS FELT AN ATTEMPT WAS MADE TO REMOVE STENT BACK INTO THE 6F GUIDE AND OUT OF THE BODY. WHEN THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED OUT OF THE SHEATH THE STENT WAS MISSING. IMAGING WAS CONDUCTED ON THE PATIENT'S ARMS, LEGS, AND AORTA, BUT THE STENT WAS NEVER FOUND. THE PATIENT WAS FINE OVERNIGHT AND WAS DISCHARGED THE FOLLOWING DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21736527 ↗
• InjuryMar 28, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO A LESION, STENT DISLODGEMENT OCCURRED. THE STENT COULD NOT BE RETRIEVED AND WAS CRUSHED IN PLACE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21718064 ↗
• InjuryDec 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED IN THE VESSEL. THE CASE WAS DIFFICULT AND COMPLEX. THE STENT WAS ABLE TO BE SNARED OUT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20862360 ↗
• InjuryAug 4, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING STENT DEPLOYMENT AT NOMINAL PRESSURE. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 17457172 ↗
• DeathApr 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT HAD HAD A CARDIAC ARREST BEFORE THE PROCEDURE. THE DEVICE WAS INSPECTED 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 DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON WHEN BEING PUT THROUGH A NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE DISLODGED STENT DID NOT REMAIN IN THE PATIENT AND WAS NEVER IMPLANTED. THE STENT DID NOT REACH THE VESSEL AND DID NOT DISLODGE INSIDE ONE OF THE VESSELS. THE PATIENT DIED THREE DAYS AFTER THE PROCEDURE. THERE WAS NO EVIDENCE OF THROMBOSIS OR RESTENOSIS. THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK. THE PHYSICIAN DID NOT ASSESS THAT THE DEATH EVENT WAS DIRECTLY RELATED TO THE USE OF THE RELEVANT DEVICE. THE PATIENT WAS NOT ON DUAL ANTIPLATELET THERAPY (DAPT) AT THE TIME OF THE EVENT. THE DEATH WAS NOT CAUSED BY THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822755 ↗
• MalfunctionFeb 2, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED THREE TIMES. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT A STENT STRUT WAS POKING OUT AWAY FROM THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283310 ↗
• InjuryNov 2, 2022Burst Container or Vessel; Deflation Problem; Inflation Problem; Burst Container or Vessel; Deflation Problem; Inflation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID OBTUSE MARGINAL (OM) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PREFORMED WITH ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THERE WAS NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THERE WAS BALLOON INFLATION AND DEFLATION DIFFICULTIES AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE INITIAL PREP WAS PERFORMED AND NO ISSUES WERE NOTED. HOWEVER, WHEN THE STENT WAS DEPLOYED INITIALLY IT WAS NOTICED THAT MOST OF THE BALLOON LOOKED LIKE IT WAS FILLED WITH AIR. THE DIAL ON THE INFLATION DEVICE WENT UP TO 14 ATM SO IT APPEARED THE BALLOON HAD INFLATED. THE BALLOON WAS THEN RE-PREPPED WHILE STILL INSIDE THE STENT AND WAS INFLATED AGAIN. THE INFLATION DEVICE WAS ALSO RE-PREPPED. THE BALLOON WAS SLOWLY INFLATED TO 14 ATM AND IT APPEARED TO SUCCESSFULLY DEPLOY THE STENT. AN ATTEMPT WAS THEN MADE TO DEFLATE THE BALLOON BUT THE BALLOON WOULD NOT DEFLATE. MULTIPLE ATTEMPTS WERE MADE TO D

  Patient problems: Chest Pain; Insufficient Information; Non specific EKG/ECG Changes

  MAUDE report 15714369 ↗