Onyx Frontier™ ONYXNG20022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000511159), received between Oct 6, 2022 and Jun 5, 2026 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN THE STENT WAS UNABLE TO CROSS A CALCIFIED, TORTUOUS LESION. UPON REMOVAL OF THE DELIVERY SYSTEM, THE STENT EMBOLISED OFF THE DELIVERY CATHETER AND TRAVELLED DOWN TO THE LEFT SUPERFICIAL FEMORAL ARTERY/PROFUNDA. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE FROM A RIGHT FEMORAL APPROACH. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Foreign Body Embolism

  MAUDE report 25408949 ↗
• InjuryMar 6, 2026Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT THAT STENT DISLODGEMENT OCCURRED. THE STENT FELL OFF THE BALLOON DURING ATTEMPTED DELIVERY TO A LESION IN THE CIRCUMFLEX (CX) ARTERY/OBTUSE MARGINAL (OM) ARTERY. DURING THE PROCEDURE A STENT WAS DEPLOYED IN THE LEFT MAIN (LM) ARTERY. AN ATTEMPT WAS THEN MADE TO PLACE THE ONYX FRONTIER STENT INTO THE CX/OM. WHEN ATTEMPTING TO PUSH THE ONYX FRONTIER STENT PAST THE NEWLY DEPLOYED STENT IN THE LEFT MAIN, THE STENT HOOKED TO THE NEW LEFT MAIN STENT AND FELL OFF THE BALLOON INTO THE LM. WITH THE TECHNIQUE THAT WAS USED TO REMOVE THE UNDEPLOYED STENT BOTH STENTS WERE REMOVED AT THE SAME TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529033 ↗
• InjurySep 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT 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 DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE STENT STRIPPED FROM THE BALLOON IN THE VESSEL AND WAS PINNED UP TO THE VESSEL WALL WITH ANOTHER DES. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 20116712 ↗
• MalfunctionApr 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING SHEATH REMOVAL. THE STENT CAME OFF THE DELIVERY SYSTEM BALLOON PRIOR TO USE, UPON REMOVING THE PROTECTIVE SHEATH AND STYLET. THE STENT REMAINED ON THE STYLET. IT WAS DETAILED THAT THE STENT DELIVERY SYSTEM BALLOON WAS THEN INSERTED INTO THE PATIENT, WITHOUT REALIZING THAT THE STENT HAD COME OFF AND WAS STILL ON THE STYLET. THE STENT ITSELF NEVER ENTERED THE PATIENT OR THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830540 ↗
• MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE 2.00 X 22MM ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE DETACHED MID-SHAFT DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE OVERALL CASE WAS DESCRIBED AS CHALLENGING, THE PATIENT'S BP (BLOOD PRESSURE) AND O2 (OXYGEN) WERE PROBLEMATIC FROM EARLY IN THE PROCEDURE. A 2.50 X 34MM ONYX FRONTIER WAS IMPLANTED IN THE MID-SECTION OF THE LAD AND THE 2.00 X 22MM ONYX FRONTIER WAS TO BE PLACED IN THE DISTAL SEGMENT. RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE DELIVERY SYSTEM THROUGH THE GUIDE CATHETER SO IT WAS DECIDED TO REMOVE THE SYSTEM PRIOR TO REACHING THE DISTAL END OF THE CATHETER. UPON REMOVAL IT WAS NOTED THAT THE STENT DELIVERY SYSTEM WAS IN TWO PIECES, A PROXIMAL PORTION AND A D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773103 ↗
• MalfunctionFeb 7, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310652 ↗
• MalfunctionOct 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS. 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. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT WAS DETAILED THAT THE STENT WAS PLACED HOWEVER WHEN IT WAS BEING INFLATED IT APPEARS THAT THE STENT WAS SLIDING BACKWARDS OFF THE BALLOON. IT WAS POSSIBLE TO FULLY DEPLOY THE DISLODGED STENT. A SECOND STENT WAS PLACED DISTALLY TO COVER THE ORIGINAL LESION. IT WAS STATED THAT THE ISSUE MAY NOT HAVE BEEN WITH THE STENT, THAT IT MAY JUST HAVE BEEN PREMATURELY DEPLOYED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550770 ↗