Onyx Frontier™ ONYXNG25034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000511340), received between Dec 16, 2022 and Aug 7, 2026 — classified as 4 injuries, 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  During an attempt to place an Onyx Frontier coronary Drug Eluting Stent in a Left Anterior Descending Artery (LAD) lesion, the stent dislodged from the delivery balloon in the LAD. The dislodged stent required retrieval. The stent was trapped and crushed in the patient¿s femoral artery tissue with deployment of another covered stent. No further patient complications were reported as a result of the event.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50174443 ↗
• MalfunctionDec 6, 2024Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE WITH ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES), STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT, AND PARTIAL STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS A DIFFICULT COMPLEX CASE. THE DEVICE WAS BEING USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL-MID RIGHT CORONARY ARTERY (RCA). THE PATIENT ALSO HAD DISEASE IN THE CIRCUMFLEX ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. 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 STENT DISPLACEMENT WAS NOTICED WHILE TRACKING IN THE VESSEL AND WAS TAKEN OUT BEFORE THE STENT CAME FURTHER OFF THE BALLOON. IT WAS POSSIBLE TO REMOVE THE STENT AS IT HAD ONLY PARTIAL DISLODGED FROM THE BALLOON AND REMAINED ON THE DELIVERY SYSTEM. A RIGHT RADIAL APPROACH WAS USED. A GUIDE CATHETER ENGAGED THE RCA, AND A NON-MEDTRONIC (MDT) WIRE WAS ADVANCED DOWN TO THE DISTAL RIGHT POSTEROLATERAL BRANCH. THE LESION WAS PRE-DILATED WITH A 2.5MM BALLOON. A NON-M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862336 ↗
• MalfunctionDec 2, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT IN A PROCEDURE, AND THE STENT FAILED TO CROSS THE PROXIMAL LESION. IT WAS ALSO REPORTED THAT THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817534 ↗
• MalfunctionSep 13, 2024Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION 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. 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT GOT HOOKED ON CALCIUM. THE DISLODGED STENT WAS REMOVED WITH THE ENTIRE SYSTEM, INCLUDING THE GUIDE AND 6F NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212045 ↗
• InjuryNov 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, NON-TORTUOUS LESION. THE DEVICE WAS INSPECTED. THE SHEATH WAS REMOVED PER IFU. THE STENT WAS NOT HANDLED DIRECTLY POST REMOVAL OF THE SHEATH. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. SOME RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT BECAME DISLODGED IN VIVO WHILE ATTEMPTING TO CROSS ANOTHER STENT. AN ATTEMPT WAS MADE TO SNARE THE STENT BUT WAS UNSUCCESSFUL. THE STENT WAS CRUSHED UP AGAINST THE SIDE WALL OF THE VESSEL WITH A 3.5X15MM NC SPRINTER BALLOON. THERE WERE NO ISSUES NOTED WITH THE NC SPRINTER DEVICE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18204066 ↗
• InjuryAug 28, 2023Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT THE STENT WAS REMOVED WITH A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17629967 ↗
• MalfunctionAug 16, 2023Entrapment of Device; Material Deformation; Positioning Problem; Entrapment of Device; Material Deformation; Positioning Problem

  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 LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS BELIEVED THAT THE WIRE WAS UNDER THE STRUT OF A STENT THAT HAD ALREADY BEEN PLACED AND WHEN IT WAS ATTEMPTED TO MOVE FORWARD TO PLACE THE ONYX FRONTIER STENT IT WOULD NOT GO OR CROSS. WHEN THE ONYX FRONTIER STENT WAS PULLED BACK, IT WAS FOUND THAT THE END OF THE STENT WAS DEFORMED. ANOTHER SAME SIZE ONYX FRONTIER STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558038 ↗
• InjuryDec 16, 2022Device Damaged by Another Device; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID 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 TO PROTECT THE SIDE BRANCH FROM PLAQUE SHIFT THE LESION WAS WIRED WITH A NON-MEDTRONIC (MDT) GUIDEWIRE. THE ONYX FRONTIER DEVICE WAS DEPLOYED ACROSS THIS SIDE BRANCH, TRAPPING THE NON-MDT GUIDEWIRE BEHIND THE ONYX FRONTIER. THE PROXIMAL END OF THE ONYX FRONTIER DEVICE WAS ABOUT 20 MM PROXIMAL TO THE WIRED SIDE BRANCH. IT WAS NOT POSSIBLE TO REMOVE THE TRAPPED WIRE. AN ATTEMPT WAS MADE TO ADVANCE SEVERAL LOW-PROFILE BALLOONS ON THE TRAPPED WIRE HOPING THEY COULD SLIP BEHIND THE STENT AND FREE THE WIRE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS AND AS A RESULT OF PULLING ON THE WIRE, THE WIRE FRACTURED, LEAVING THE WIRE IN THE PATIENT VASCULATURE. THE WIRE WAS SUCCESSFULLY REMOVED DURING SURGERY. NO D

  Patient problems: Insufficient Information

  MAUDE report 15994457 ↗