Onyx Frontier™ ONYXNG45022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000511753), received between Jul 26, 2023 and Oct 30, 2025 — classified as 1 injury, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. THE LESION BEING TREATED WAS NON-TORTUOUS, MODERATELY CALCIFIED IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). NEGATIVE PREP WAS PERFORMED PRIOR TO USE WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. INTRAVASCULAR ULTRASOUND (IVUS) WAS CONDUCTED, AND IT WAS NOTED THAT THE DEGREE OF CALCIUM WAS UNDERESTIMATED. THE STENT DID NOT CROSS THE LESION ON THE FIRST ATTEMPT, SO IT WAS REMOVED TO PREVENT FURTHER DILATION. UPON INSPECTION PRIOR TO REINSERTION, THE STENT WAS NOTICED TO BE BUNCHED UP ON BALLOON. IT WAS STATED THAT THE ISSUE WAS ATTRIBUTED TO THE CALCIUM PRESENT,NOT THE STENT ITSELF. A NON-MEDTRONIC GUIDE EXTENSION CATHETER AND A NEW STENT WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424865 ↗
• InjuryNov 27, 2023Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  THE PATIENT WAS ADMITTED TO HOSPITAL WITH A MYOCARDIAL INFARCTION. AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% LESION STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 3.0MM NON-MEDTRONIC 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. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE EXPERIENCED DURING STENT DEPLOYMENT. THE STENT WAS IN THE RCA BUT WOULD NOT INFLATE ABOVE 4 ATM. THE BALLOON KEPT POPPING LIKE THE BALLOON HAD BURST. A COUPLE OF INFLATIONS WERE ATTEMPTED, AND THE INDEFLATOR WAS REMOVED AND A NEW ONE TRIED, BUT THE STENT STILL WOULDN¿T INFLATE. IT WAS POSSIBLE TO REMOVE THE WHOLE SYSTEM WITH THE STENT PARTIALLY DEPLOYED BACK TO GROIN. USING THE LEFT GROIN, THE LESION WAS RE-WIRED AN D A 4.0X22MM ONYX FRONTIER STENT WAS PLACED, FIXING THE ARTERY. THE PATIENT WAS THEN FLOWN TO ANOTHER FACILITY WITH THE SHEATH AND GUIDE SEWN I

  Patient problems: Insufficient Information

  MAUDE report 18210526 ↗
• MalfunctionJul 26, 2023Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A SEVERELY CALCIFIED AND NON TORTUOUS LESION LOCATED IN THE OSTIUM OF RIGHT CORONARY ARTERY (RCA). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES BEING NOTED. NEGATIVE PREP WAS NOT PERFORMED ON THE DEVICE. 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 USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO/AT LESION. THE ONYX FRONTIER STUCK TO THE WIRE. THE STENT WIRE WAS PULLED OUT WITH THE WIRE. THE PATIENT IS ALIVE, WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17394725 ↗