Onyx Frontier™ ONYXNG40018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000511661), received between Jul 14, 2022 and Mar 19, 2026 — classified as 3 injuries, 5 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 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.

• InjuryMar 19, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE TARGET LESION WAS LOCATED IN THE DISTAL SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES FOUND. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636786 ↗
• MalfunctionNov 20, 2025Deformation Due to Compressive Stress; Device Damaged by Another Device; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Device Damaged by Another Device; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE LESION BEING TREATED WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON THE DEVICES. THE LESION WAS PRE-DILATED. BOTH DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF BOTH DEVICES. THE STENTS WENT THROUGH THE GUIDE EXTENSION CATHETER SMOOTHLY BUT WHILE TRYING TO DELIVER STENTS TO THE LESION, RESISTANCE WAS MET AND THE STENTS WERE REMOVED. UPON INSPECTION OF BOTH STENTS AFTER REMOVAL, IT WAS NOTICED THAT THE STENT STRUTS WERE LIFTED. IT WAS NOTED THAT THE VESSEL WAS HEAVILY CALCIFIED AND THAT A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS USED SO IT WAS BELIEVED THAT STRUTS MAY HAVE CAUGHT ON THE NON-MEDTRONIC GUIDE EXTENSION CATHETER UPON REMOVAL OR WERE DAMAGED DURING THE ATTEMPT TO DELIVER STENT TO LESION. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602563 ↗
• MalfunctionNov 20, 2025Device Damaged by Another Device; Material Deformation; Positioning Problem; Device Damaged by Another Device; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE LESION BEING TREATED WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON THE DEVICES. THE LESION WAS PRE-DILATED. BOTH DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF BOTH DEVICES. THE STENTS WENT THROUGH THE GUIDE EXTENSION CATHETER SMOOTHLY BUT WHILE TRYING TO DELIVER STENTS TO THE LESION, RESISTANCE WAS MET AND THE STENTS WERE REMOVED. UPON INSPECTION OF BOTH STENTS AFTER REMOVAL, IT WAS NOTICED THAT THE STENT STRUTS WERE LIFTED. IT WAS NOTED THAT THE VESSEL WAS HEAVILY CALCIFIED AND THAT A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS USED SO IT WAS BELIEVED THAT STRUTS MAY HAVE CAUGHT ON THE NON-MEDTRONIC GUIDE EXTENSION CATHETER UPON REMOVAL OR WERE DAMAGED DURING THE ATTEMPT TO DELIVER STENT TO LESION. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23602549 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INITIAL PROCEDURE THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION MANIFESTED BY A SEVERE 90% STENOSIS INVOLVING THE DISTAL LEFT MAIN CORONARY ARTERY EXTENDING INTO THE PROXIMAL SEGMENTS OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX CORONARY ARTERIES. THREE STENTS WERE IMPLANTED: A 3.0 X 15MM ONYX FRONTIER STENT, A 4.0 X 18 MM ONYX FRONTIER STENT, AND A 4.5 X 18MM ONYX FRONTIER STENT IMPLANTED. A 0.014 NON-MEDTRONIC WIRE WAS ADVANCED AND PLACED WITHIN THE DISTAL SEGMENT OF THE LAD. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 0.014 NON-MEDTRONIC WIRE WAS PLACED WITHIN THE 1ST OBTUSE MARGINAL BRANCH. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM PRIMARY ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY EXTENDING INTO THE PROXIMAL LAD. AN IVUS CATHETER WAS THEN ADVANCED AND IVUS ASSESSMENT OF THE LEFT MAIN CORONARY ARTERY AND LAD WAS OBTAINED. NEXT, A 2.5 X 12 MM BALLOON WAS USED FROM FURTHER ANGIOPLASTY OF THE DISTAL LEFT MAIN CORONARY INTO THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. AN ONYX FRONTIER 3 X 15 MM DRUG-ELUTING STENT WAS THEN ADVANCED AND PLACED WITHIN THE PROXIMAL LEFT CIRCUMFLEX CORONARY EXT

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Ischemia; Myocardial Infarction

  MAUDE report 23036038 ↗
• InjuryJul 24, 2025Fracture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Fracture; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT WAS IMPLANTED IN THE DUCTUS ARTERIOSUS OF A PATIENT AND APPROXIMATELY 8 WEEKS POST THE PROCEDURE IT WAS INCIDENTALLY FOUND THAT DISTAL STENT HAD FRACTURED AND MIGRATED TO THE DESCENDING AORTA. THE INITIAL PROCEDURE WAS FOR PLACEMENT OF A DUCTAL STENT WITHIN A PREVIOUSLY PLACED DUCTAL STENT. THE ONYX FRONTIER STENT WAS PLACED AS THE NEW SECOND STENT. THE LESION HAD NO CALCIUM, WAS HIGHLY TORTUOUS DUCTUS ARTERIOSUS WITH STENT EXTENSION IN TO THE AORTA. THE DISTAL SEGMENT OF THE STENT EXTENDED IN TO THE AORTA TO THE BACK WALL. THE PATIENT RETURNED FOR A ROUTINE PRE-GLENN CATHETERIZATION WAS INCIDENTALLY FOUND TO HAVE A STENT FRAGMENT THAT HAD EMBOLIZED DISTALLY TO THE DESCENDING AORTA. THERE WAS NO PRESSURE GRADIENT, HOWEVER, THE STENT APPEARED EMBEDDED IN THE VASCULATURE AND WAS NOT ABLE TO BE REMOVED PERCUTANEOUSLY. VASCULAR SURGERY WAS CONSULTED AND RECOMMEND SURGICAL REMOVAL IN THE FUTURE WHEN SYMPTOMATIC. THE PATIENT WAS REPORTED TO BE STABLE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22585596 ↗
• MalfunctionJun 9, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS DISLODGED DURING DELIVERY TO/AT LESION. THE LESION BEING TREATED WAS MODERATELY TORTUOUS LOCATED IN THE OSTIUM LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE 2.25X18MM ONYX FRONTIER STENT HAD TO BE CRUSHED AT THE LESION USING A NON-MEDTRONIC STENT. THE 4.00X18MM ONYX FRONTIER STENT WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165007 ↗
• MalfunctionAug 6, 2024Device 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 LESION. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915714 ↗
• MalfunctionJul 14, 2022Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE MID SAPHENOUS VEIN GRAFT (SVG). NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THEBALLOON BURST DURING STENT DEPLOYMENT AT 12 ATM (NOMINAL PRESSURE). IT WAS DETAILED THAT THE STENT WAS DELIVERED ON A SPIDER WIRE THAT WAS SNAPPED AT 190 MM. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011622 ↗