Onyx Frontier™ ONYXNG40034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000511708), received between Dec 12, 2023 and Mar 31, 2025 — classified as 2 injuries.

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

• InjuryMar 31, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO THE LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE STENT CAUGHT ON THE STRUTS OF A MEDTRONIC COREVALVE DEVICE DURING DELIVERY AND DISLODGED. THE LESION HAD SEVERE CALCIFICATION AND MODERATELY TORTUOUS. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP PERFORMED WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DISLODGED STENT WAS NOT REMOVED. IT WAS POSSIBLE TO DEPLOY THE STENT AFTER THE DISLODGEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729368 ↗
• InjuryDec 12, 2023Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  THE PATIENT PRESENTED WITH A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED IN VIVO. IT WAS DETAILED THAT A STENT WAS SUCCESSFULLY DEPLOYED IN THE RCA. WHEN A SECOND STENT, THE ONYX FRONTIER STENT WAS BEING PLACED, THE STENT WAS STRIPPED FROM THE DELIVERY SYSTEM BUT REMAINED ON THE CORONARY WIRE. THE DISLODGED STENT WAS MOVED TO THE RADIAL ARTERY HOWEVER, IT COULD NOT BE REMOVED THROUGH THE RADIAL SHEATH. VASCULAR SURGERY WAS CONTACTED AND THE PATIENT WAS TAKEN FOR SURGICAL REMOVAL OF THE STENT. IT WAS NOTED THAT THE PATIENT WAS HEMODYNAMICALLY STABLE WHEN COMING OUT OF THE OPERATING ROOM. NO FURTHER PATIENT INJURY WAS REPORTED.

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

  MAUDE report 18315214 ↗