Onyx Frontier™ ONYXNG27534UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000511432), received between Sep 1, 2023 and Jul 17, 2025 — classified as 1 death, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FELL OFF THE BALLOON DURING ATTEMPTED DELIVERY IN A STAGED PERCUTANEOUS CORONARY INTERVENTION (PCI). THE LESION WAS CALCIFIED WITH NO TORTUOSITY AND 90% STENOSIS AND WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PRE-DILATED WITH A NON-COMPLIANT BALLOON. THE STENT WAS ADVANCED TO THE LESION, HOWEVER IT WOULD NOT DELIVER TO THE TARGET LESION. THE STENT WAS REMOVED UNDEPLOYED BUT IT WAS NOTED THAT THE STENT HAD COME OFF THE DELIVERY SYSTEM. BALLOONS, WIRES AND SNARES WERE UTILIZED IN MULTIPLE ATTEMPTS TO REMOVE THE STENT WHICH WERE UNSUCCESSFUL. THE STENT WAS NOT REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22528653 ↗
• InjuryJan 8, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING THE DEPLOYMENT OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, A BALLOON BURST OCCURRED AT 8ATM ON THE FIRST INFLATION AND IT WAS ALSO REPORTED THAT THE LAD ARTERY RUPTURED. THE RUPTURED LAD WAS TREATED USING A COVERED STENT, CARDIOPULMONARY RESUSCITATION (CPR), AND INTUBATION. DURING THE PROCEDURE THE LESION WAS PRE-DILATED, THEN A ROTATIONAL ATHERECTOMY DEVICE WAS USED ALONG WITH INTRAVASCULAR LITHOTRIPSY THERAPY BEFORE DEPLOYING THE STENT. THE STENT WAS DELIVERED TO THE LESION AND DEPLOYED AT NOMINAL PRESSURE AND NOT OVER-INFLATED HOWEVER THE LAD RUPTURED UPON DEPLOYMENT. IT WAS INITIALLY BELIEVED THAT THE STENT PUSHED CALCIUM OUT OF THE VESSEL WALL. HOWEVER, UPON FURTHER REVIEW, A LOSS OF PRESSURE WAS OBSERVED IN THE INDEFLATOR AND THE PRESENCE OF CONTRAST WAS NOTED. SINCE NO CONTRAST WAS INJECTED, THE ONLY EXPLANATION FOR ITS PRESENCE WOULD BE IF THE BALLOON HAD RUPTURED. THE LAD ARTERY SHOWED MODERATE CALCIFICATION AND AN 80% STENOSIS, WITH NO TORTUOSITY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED

  Patient problems: Cardiac Tamponade; Insufficient Information; Rupture; Vascular Dissection

  MAUDE report 21100416 ↗
• DeathFeb 19, 2024Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 70% STENOSIS 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. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING BALLOON INFLATION. RIGHT RADIAL ACCESS WAS OBTAINED. A 3.5 EBU LAUNCHER DEVICE WAS ENGAGED IN THE LEFT MAIN (LM). PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED WITH A 2.75MM EUPHORA RX BALLOON TO THE PROXIMAL LAD. A 2.75X34MM ONYX FRONTIER STENT WAS THEN DELIVERED AND DEPLOYED IN THE PROXIMAL/MID LAD. THE NC EUPHORA BALLOON WAS INFLATED IN THE DEPLOYED STENT BUT RUPTURED AND DEFLATED. THE BALLOON HAD BEEN INFLATED TO 10 ATM FOR 15 SECONDS, 14 ATM FOR 20 SECONDS AND 18 ATM FOR 20 SECONDS PRIOR TO THE RUPTURE. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THE BALLOON DEFLATED UPON RUPTURE AND COUL

  Patient problems: Cardiac Arrest; Insufficient Information; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion; Shock; Thrombosis/Thrombus

  MAUDE report 18729343 ↗
• InjuryNov 27, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  THE PATIENT PRESENTED TO HOSPITAL COMPLAINING OF A FEW HOURS OF PRECORDIAL DISCOMFORT. ON ADMISSION THE PATIENT WAS FOUND TO HAVE AN TEROSEPTAL ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS BROUGHT URGENTLY TO THE CARDIAC CATHETERIZATION LABORATORY FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION WITH 100% STENOSIS, LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THELEFT MAIN (LM) ARTERY HAD 75% STENOSIS. THERE WAS A 90-DEGREE BEND FROM THE LM TO THE LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A SEMI COMPLIANT BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED DURING REMOVAL. IT WAS DETAILED THAT A NON-MEDTRONIC (MDT) GUIDE CATHETER WAS USED IN THE RIGHT RADIAL ARTERY. AFTER ENGAGEMENT IN THE LM, THE LAD WAS WIRED WITH A NON-MDT 0.014 GUIDEWIRE. OV

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

  MAUDE report 18211436 ↗
• MalfunctionSep 1, 2023Material Deformation; Material Deformation

  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. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670009 ↗