Onyx Frontier™ ONYXNG35015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000511562), received between Aug 16, 2022 and Jul 30, 2026 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Device Dislodged or Dislocated; Positioning Problem

  During a procedure an attempt was made to use one Onyx Frontier coronary Drug Eluting Stent when stent dislodgement occurred during removal following failed delivery. The device was inspected with no issues. Negative prep was not performed. The lesion was pre-dilated. The lesion being treated was a mildly tortuous, mildly calcified lesion with 80% stenosis located in the proximal Circumflex (CX) Artery. An attempt was made to deploy the stent in the proximal LCX when it came off the catheter. The stent and wire were pulled back into the guide, but the stent exited into the femoral sheath. It was snared down to the femoral artery and surgically removed. The device did not pass through a previously-deployed stent. There was no resistance encountered when advancing the device, and excessive force was not used during delivery. No further patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086535 ↗
• MalfunctionMay 21, 2026Device Dislodged or Dislocated

  DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS, IT WAS REPORTED THAT ONE ONYX FRONTIER STENT DISLODGED WITHIN A 6F LAUNCHER GUIDE CATHETER AND ONE ONYX FRONTIER STENT DEFORMED RIGHT OUT OF THE HOOP. THE ONYX FRONTIER STENT THAT DISLODGED IN THE GUIDE CATHETER WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THERE WAS NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH/STYLETTE. THE STENT WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE LESION BEING TREATED WAS NON CALCIFIED. THE 6F LAUNCHER GUIDE CATHETER WAS IN THE PATIENT'S VESSEL WHEN THE STENT BECAME DISLODGED WITHIN THE GUIDE. THE DISLODGED STENT WAS REMOVED. THERE WERE NO ISSUES REPORTED WITH THE GUIDE CATHETER AND THE GUIDE CATHETER WAS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE STENT DISLODGEMENT. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. NO RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE TO THE LESION. THE ONYX FRONTIER STENT THAT DEFORMED RIGHT OUT OF THE HOOP WAS INSPECTED AFTER REMOVAL OF THE PROTECTIVE SHEATH AND STRUT DEFORMATION WAS OBSERVED. THERE WAS NO DAMAGE NOTED TO THE PACKAGI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238839 ↗
• InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, AS THE DEVICE WAS BEING DELIVERED TO THE LESION, THE STENT STARTED TO COME OFF THE BALLOON IN THE RIGHT CORONARY ARTERY (RCA). THE RCA CAME OFF THE LEFT CUSP AT A 180 DEGREE ANGLE AND WAS VERY TORTUOUS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. EVERYTHING WAS PULLED OUT INTO THE AORTA WHERE THE STENT FELL OFF. A SNARE WAS ATTEMPTED TO BE USED. THE DISLODGED STENT WAS UNABLE TO BE SNARED WITH A 6F SYSTEM SO THIS WAS UPGRADED TO 8F SYSTEM WHICH SUCCESSFULLY RETRIEVED THE STENT. THE PATIENT IS REPORTED TO BE ALIVE AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356141 ↗
• MalfunctionJun 20, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT CAME OFF THE STENT DELIVERY SYSTEM WHEN THE DEVICE WAS BEING REPOSITIONED IN THE CORONARY ARTERY. THE STENT WAS DEPLOYED IN PLACE. ANOTHER STENT WAS PLACED AT THE LESION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22296924 ↗
• InjuryAug 26, 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 LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE ONYX FRONTIER WAS ADVANCING IN THE PROXIMAL RCA WHEN THE STENT DISLODGED AND TRAVELLED DISTALLY WITHIN THE RCA. ANOTHER PHYSICIAN THEN OPENED THE STENT. IT IS UNKNOWN WHETHER THE STENT WAS OPENED SUCCESSFULLY WITHIN THE LUMEN, OR IF IT WAS A STENT EXCLUDE TECHNIQUE, AND ANOTHER STENT WAS DEPLOYED TO OPPOSE THE DISLODGED STENT WITHIN THE VESSEL. THE DISLODGED STENT WAS NOT REMOVED. ANOTHER DES WAS IMPLANTED IN THE PROXIMAL LESION. THE PATIENT IS STABLE AND WAS NOT HARMED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 20063446 ↗
• MalfunctionAug 21, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017322 ↗
• MalfunctionNov 10, 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 NON TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED WITH THE DELIVERY SHAFT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111614 ↗
• InjuryMar 10, 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 IN THE OSTIUM OF THE LEFT MAIN(LM) CORONARY ARTERY AND CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. IT WAS DETAILED THAT THE PATIENT IS BEING TRANSFERRED TO A SURGICAL HOSPITAL WHERE A PCI (PERCUTANEOUS CORONARY INTERVENTION) WILL BE ATTEMPTED TO REMOVE THE DISLODGED STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16522970 ↗
• MalfunctionMar 9, 2023Material 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511157 ↗
• InjuryMar 3, 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 MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 LESION WAS WIRED AND A PERCUTANEOUS OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. DURING THE INITIAL ATTEMPT TO ADVANCE THE STENT, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE STENT WAS REMOVED SUCCESSFULLY AND WAS INTACT WITH NO DAMAGE. ANOTHER POBA WAS PERFORMED AND THE STENT WAS REINTRODUCED A SECOND TIME AND ADVANCED TO THE LESION. THE STENT FAILED TO CROSS THE LESION DESPITE A SUSTAINED PUSH AGAINST SIGNIFICANT CALCIFICATION. AN ATTEMPT WAS MADE TO REMOVE THE STENT HOWEVER BEFORE REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE GUIDE TIP AT THE OSTIUM, IT WAS NOTICED THAT THE STENT WAS NO LONGER ON THE CATHETER. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT BY TRAPPING IT ON THE ORIGINAL COR

  Patient problems: Insufficient Information

  MAUDE report 16477321 ↗
• InjuryFeb 15, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DETAILED THAT THIS WAS THE THIRD STENT ATTEMPTING TO BE DELIVERED AFTER PREVIOUSLY DEPLOYING TWO OTHER STENTS SUCCESSFULLY. THERE WAS DIFFICULTY TRYING TO REMOVE THE DISLODGED STENT. THE DEVICE WAS NOT REMOVED FROM THE PATIENT. AN NC BALLOON WAS USED TO SMASH THE DISLODGED STENT IN TO THE WALL OF THE RIGHT CORONARY ARTERY (RCA). NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16378228 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE ONYX FRONTIER DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. DURING THE PROCEDURE A SMALL DISTAL EDGE DISSECTION OCCURRED AFTER THE PLACEMENT OF THE FIRST STENT. THE DISSECTION WAS TREATED USING ANOTHER STENT. THE PATIENT RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 15231222 ↗