Onyx Frontier™ ONYXNG40030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000511692), received between Jul 29, 2022 and Feb 11, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY WHICH EXHIBITED MILD TORTUOSITY, MODERATE CALCIFICATION AND 70% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. IT WAS ATTEMPTED TO PUSH THE DEVICE THROUGH SIGNIFICANT PLAQUE BURDEN OF 80%. THE VESSEL WAS CALCIFIED IN THE OSTIAL SECTION OF THE VESSEL BUT THIS WAS NOT TREATED, THE STENT FRACTURED DURING DELIVERY THROUGH THE VESSEL BUT WAS NOT DEPLOYED. THE ENTIRE DEVICE WAS REMOVED FROM THE BODY WITH DEFORMATION/CRACKING TO THE STENT CELLS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313758 ↗
• MalfunctionApr 15, 2024Material 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 NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DETAILED THAT WHEN THE STENT REACHED THE LESION SOMETHING FELT FUNNY. IT WAS DECIDED TO STOP AND RETRIEVE THE STENT. IT WAS NOTED THAT A STENT/SPUR MALFORMATION HAD OCCURRED. THE STENT WAS REPLACED WITH ANOTHER SAME SIZE ONYX FRONTIER STENT HOWEVER, A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS USED TO DELIVERY THE STENT TO THE LESION. THE ONYX FRONTIER STENT WAS EXPANDED WITH NO ISSUES. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110627 ↗
• InjuryJun 12, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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 DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17105016 ↗
• InjuryJul 29, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Material Deformation; Migration or Expulsion of Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% MID-DISTAL STENOSIS LOCATED IN THE OSTIUM OF THE SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT IN VIVO OCCURRED DURING DELIVERY TO THE LESION. IT WAS STATED THAT THE STENT CAME OFF THE BALLOON AND IT WAS REMOVED USING A SPIDER DEVICE. A NON-MEDTRONIC DEVICE WAS THEN DEPLOYED SUCCESSFULLY. NO OTHER TREATMENT WAS DONE TO THE LESION. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15127790 ↗