Onyx Frontier™ ONYXNG20026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000511166), received between Dec 6, 2022 and Feb 12, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING WITHIN A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. 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, AND EXCESSIVE FORCE WAS USED DURING DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321861 ↗
• MalfunctionJun 12, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE LESION BEING TREATED WAS A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING A NUMBER OF NON-MEDTRONIC SEMI-COMPLIANT AND NON-COMPLIANT BALLOONS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THERE WERE TWO ATTEMPTS MADE TO DELIVER THE STENT BUT THEY WERE UNSUCCESSFUL. UPON REMOVAL OF THE STENT AFTER THE SECOND ATTEMPT, THE STENT FOUND TO BE MANGLED AT THE TIP AREA. THE PROCEDURE WAS COMPLETED WITH TWO SMALLER ONYX FRONTIER STENTS BEING IMPLANTED. THE PATIENT WAS REPORTED TO BE FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194033 ↗
• MalfunctionOct 25, 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 MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY OF THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532373 ↗
• InjurySep 17, 2024Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY TORTUOUS LESION IN THE MID DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. AFTER THE STENT COULD NOT BE DELIVERED, THE DELIVERY SYSTEM WAS PULLED BACK FROM THE LESION BUT THE STENT CAME OFF AND WAS IN BETWEEN THE GUIDE AND THE AORTA. A SNARE WAS USED TO TRY TO REMOVE THE STENT. WHEN TRYING TO POSITION THE SNARE, THE DISLODGED STENT MOVED BACK INTO THE SUPERFICIAL FEMORAL ARTERY (SFA) GROIN AREA BUT WAS ABLE TO BE RETRIEVED AND REMOVED. NO STENT WAS USED TO TREAT POTENTIAL LESION IN SECOND DIAGONAL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20234713 ↗
• InjuryMay 24, 2024Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THE PATIENT HAD TORTUOUS VESSELS. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT DEVICE PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED. AFTER REVIEW OF THE PROCEDURAL FILMS, IT SEEMS LIKELY THAT THE STENT CAUGHT ON THE PREVIOUSLY IMPLANTED MEDTRONIC TAVR VALVE, OR ON THE PREVIOUSLY IMPLANTED PROXIMAL LAD STENT WHEN THE DELIVERY SYSTEM WAS ATTEMPTED TO PASS THROUGH PREVIOUS STENT. THE STENT WOULD NOT CROSS, WAS PULLED BACK AND DISLODGED IN THE LM. THE STENT WAS CRUSHED IN THE LM WITH AN ADDITIONAL STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19391297 ↗
• MalfunctionFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY. THERE WERE NO ISSUES REMOVING DEVICE FROM HOOP. THERE WERE NO ISSUES DURING PREP. THERE WAS SOME RESISTANCE ENCOUNTERED WHILE TRYING TO DELIVER THE STENT TO THE LESION. NO EXCESSIVE FORCE WAS USED WHILE DELIVERING THE STENT. IT WAS REPORTED THAT THE SHAFT OF THE STENT SNAPPED AND BROKE IN HALF WHEN PLACING THE STENT DOWN THE VESSEL. IT WAS STATED THAT THE SHAFT SNAPPED OUTSIDE THE PATIENT SO IT WAS EASY TO REMOVE. ANOTHER SAME SIZE STENT WAS THEN USED. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740944 ↗
• InjuryJan 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 BEFORE IT WAS DEPLOYED. A WIRE AND A NON MDT GUIDE EXTENSION CATHETER WERE ALSO USED DOWN THE VESSEL. THE STENT WAS ABLE TO BE DEPLOYED WITH NEW BALLOON. NO FURTHER PATIENT INJURY WAS REPORTED. NOTE: THE PROCEDURES PERFORMED WERE RIGHT FEMORAL SHEATH SIDE-PORT ANGIOGRAPHY; BALLOON ANGIOPLASTY; PERCUTANEOUS INTERVENTION ON THE 90% DE NOVO STENOSIS IN THE PROXIMAL LAD, INTERVENTIONAL IVUS EXAMINATION, STENT PLACEMENT, BALLOON ANGIOPLASTY; PERCUTANEOUS INTERVENTION ON THE 75% DE NOVO STENOSIS IN THE PROXIMAL 1ST OBTUSE MARGINAL, BALLOON ANGIOPLASTY; PERCUTANEOUS INTERVENTION ON THE 80% DE NOVO STENOSIS IN THE PROXIMAL LEFT CIRCUMFLEX, STENT PLACEMENT, BALLOON ANGIOPLASTY.

  Patient problems: Insufficient Information

  MAUDE report 16120572 ↗
• InjuryDec 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS, IN THE DISTAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THOUGH 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 FAILED DELIVERY. THE STENT WAS ATTEMPTED TO BE DELIVERED THREE TIMES INTO THE SEVERELY TORTUOUS AND CALCIFIED VESSEL. THE STENT DISLODGED FROM THE CATHETER AFTER THE THIRD ATTEMPT AND WAS RETRIEVED BY A SNARE. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15985186 ↗
• MalfunctionDec 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DEVICE TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED, NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING A 1.0 NON MEDTRONIC BALLOON DILATION CATHETER, A 2.0 EUPHORA DEVICE AND ALSO A 2.25 NC EUPHORA DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT WAS FOUND IN THE GUIDE CATHETER HUB AND WAS REMOVED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924084 ↗