Onyx Frontier™ ONYXNG40015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000511654), received between Nov 10, 2022 and May 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Use of Device Problem; Use of Device Problem

  ONE ONYX FRONTIER DRUG ELUTING STENT WAS IMPLANTED TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE PRO XIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 DU RING DELIVERY. IT WAS REPORTED THAT THE EXPIRED STENT WAS IMPLANTED. IT WAS NOTICED THAT THE STENT WAS EXPIRED AFTER IT WAS DEPLOYED. THERE WAS NO DEVICE MALFUNCTION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339020 ↗
• MalfunctionSep 25, 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 DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% LESION STENOSIS LOCATED IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED ON THE DEVICE. 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 NOT USED DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT WHEN ATTEMPTING TO DELIVER AND POSITION THE SENT IN THE LAD IT COULD NOT BE DELIVERED. THE ONYX FRONTIER DES WAS SUCCESSFULLY REMOVED AND IT WAS NOTED THAT A STENT STRUT WAS RAISED ON THE STENT DELIVERY SYSTEM (SDS). ANOTHER ONYX FRONTIER DES WAS SUCCESSFULLY DEPLOYED IN THE PATIENT. IT WAS REPORTED THAT AN OLD PREVIOUSLY PLACED STENT AT THE CIRCUMFLEX (CX) OSTIUM HAD A STRUT PROTRUDING INTO THE LEFT MAIN (LM) ARTERY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805975 ↗
• MalfunctionNov 10, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID, PROXIMAL AND OSTIUM OF THE 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. THE DEVICE DID 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. A STENT STRUT LIFTED ON AN ATTEMPT TO PASS THE STENT THROUGH A PREVIOUSLY DEPLOYED STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER ONYX FRONTIER OF THE SAME SIZE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769536 ↗