Onyx Frontier™ ONYXNG50018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000511807), received between Oct 6, 2022 and Sep 3, 2024 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Deflation Problem; Entrapment of Device; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Deflation Problem; Entrapment of Device; Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS, NON-CALCIFIED LESION IN THE MID PATENT DUCTAL ARTERIOSUS. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED. IT WAS ALSO REPORTED THAT REMOVAL DIFFICULTIES OCCURRED, AND THERE WAS DIFFICULTY REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. WHILE TRYING TO REPOSITION THE STENT IT BECAME STUCK IN THE VESSEL AND PULLED OFF THE EDGE OF THE CATHETER, AND DID NOT DEFLATE. IT IS BELIEVED THAT THE EVENT HAPPENED DUE TO PATIENT'S ANATOMY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123421 ↗
• InjuryOct 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT STENT DISLODGEMENT IN VIVO OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS NOT REMOVED. A NON-MEDTRONIC DEVICE WAS USED TO CRUSH THE STENT. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15549345 ↗