Onyx Frontier™ ONYXNG40038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000511715), received between Oct 26, 2022 and Jul 31, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT CAME OFF THE UNINFLATED BALLOON WHILE PARTIALLY IN THE CATHETER. THE STENT WAS RETRIEVED TO THE ARTERY IN THE HAND, AND THE PATIENT SUBSEQUENTLY UNDERWENT SURGERY THE NEXT DAY TO EXTRACT THE STENT. THE EVENT LED TO AN EXTENSION OF THE PATIENT'S HOSPITALIZATION. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES NOTED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22678111 ↗
• MalfunctionNov 18, 2024Difficult to Remove; Device Damaged by Another Device; Material Deformation; Positioning Problem; Difficult to Remove; Device Damaged by Another Device; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION WHEN STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS DETAILED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE STENT BALLOON WAS BEING REMOVED TO PRE-DILATE THE LESION MORE, AND WHEN REMOVING THE STENT THROUGH THE TUOHY STENT DEFORMATION WAS NOTICED. IT WAS ALSO REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.0X38MM ONYX FRONTIER STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706038 ↗
• InjuryAug 16, 2023Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 BALLOON DEFLATION DIFFICULTIES OCCURRED AT THE LESION SITE. IT WAS DETAILED THAT THE BALLOON WOULD NOT DEFLATE EVEN WHEN ATTEMPTS WERE MADE TO OVER INFLATE THE BALLOON AND POPPING WITH EXTRA WIRES. THE BALLOON WAS EVENTUALLY REMOVED BY PULLING. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17560327 ↗
• MalfunctionOct 26, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A PROXIMAL VEIN GRAFT. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT WAS BENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672522 ↗