Onyx Frontier™ ONYXNG22508UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000511180), received between Mar 2, 2023 and Feb 11, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Fracture; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, DETACHMENT OF THE DELIVERY SYSTEM OCCURRED IN VIVO DURING INSERTION. THE BODY OF THE STENT DELIVERY SYSTEM WAS BROKEN. THE STENT WAS ADVANCED INTO THE BODY AND ATTEMPTED TO CROSS THE LESION BUT WAS UNABLE TO CROSS. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE BODY WITH THE STENT INTACT. THE STENT WAS COMPLETELY REMOVED FROM THE BODY. EXCESSIVE FORCE WAS NOT USED DURING WITHDRAWAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312275 ↗
• InjuryMay 15, 2025Burst Container or Vessel; Device Dislodged or Dislocated; Burst Container or Vessel; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY STENT AT THE MID OBTUSE MARGINAL ARTERY, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION, AND THE BALLOON RUPTURED AT 4 ATMOSPHERES, WITH BLOOD NOTED IN THE INFLATION DEVICE. THE LESION HAD A 90% STENOSIS, MODERATELY CALCIFIED AND MILDLY TORTUOSITY WITH A TORTUOUS BRACHIOCEPHALIC. THE STENT WAS NOT FULLY DEPLOYED, AND AN ATTEMPT TO SNARE THE STENT WAS UNSUCCESSFUL, LEAVING THE STENT IN PLACE AT THE LESION. ANOTHER STENT WAS PLACED NEXT TO THE DISLODGED STENT, CRUSHING IT INTO THE VESSEL WALL. THE DEVICE WAS INSPECTED PRIOR TO USE 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 ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE PATIENT TOLERATED THE PROCEDURE. 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 22028170 ↗
• MalfunctionNov 15, 2024Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DURING A PROCEDURE. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH OR THE PACKAGING STYLETTE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ABNORMALITIES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE BALLOON WAS NOT INFLATED DURING NEGATIVE PREP. IT WAS REPORTED THAT THE STENT WOULD NOT DEPLOY IN THE PATIENT DUE TO THE HOLE IN THE BALLOON. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND AN ATTEMPT WAS MADE TO DEPLOY THE STENT OUTSIDE OF THE BODY WHEN FLUID WAS FOUND DRIPPING FROM THE BALLOON SHOWING THE HOLE IN THE BALLOON SYSTEM. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693714 ↗
• MalfunctionApr 11, 2024Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT WAS IMPLANTED AFTER THE USE BY DATE. THERE WAS NO ISSUE WITH THE STENT DELIVERY OR WITH THE PATIENT AFTER THE STENT WAS IMPLANTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085960 ↗
• MalfunctionNov 28, 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 CALCIFIED LESION LOCATED 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. RESISTANCE WAS ENCOUNTERED 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 18215116 ↗
• InjuryMar 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16467833 ↗