Onyx Frontier™ ONYXNG22530UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000511241), received between Dec 22, 2022 and Feb 13, 2026 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Fracture; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS, BOTH DEVICES DETACHED IN VIVO DURING DELIVERY THROUGH A LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WHICH WAS HEAVILY CALCIFIED. THE PROXIMAL CX ARTERY WAS THEN BALLOONED WITH A 4.0X15MM NC EUPHORA AND THE STENT DEVICES PASSED SUCCESSFULLY. THE DISTAL OBTUSE MARGINAL (OM) ARTERY WAS SUCCESSFULLY STENTED WITH NO ISSUES. THE TARGET LESION WAS LOCATED IN THE DISTAL OM ARTERY WHICH EXHIBITED MODERATE TORTUOSITY, SEVERE CALCIFICATION AND CHRONIC TOTAL OCCLUSION (CTO) 100%. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. THE DETACHED PORTIONS OF THE DEVICES DO NOT REMAIN IN THE PATIENT AND WERE REMOVED THROUGH THE GUIDE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330497 ↗
• InjuryJul 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE 2.25X30MM ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS LESION WITH 90% STENOSIS IN THE MID/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT MAIN (LM) CORONARY 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. IT WAS DETAILED THAT THE STENT WAS DEPLOYED USING A 1.2MM BALLOON IN SEQUENTIAL FASHION UP TO 2.5MM. NO FURTHER PATIENT INJURY WAS REPORTED.

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

  MAUDE report 17356609 ↗
• InjuryDec 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE PROXIMAL DIAGONAL ARTERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT CAME OFF THE BALLOON BEFORE IT WAS DEPLOYED. A SNARE WAS USED TO REMOVE THE STENT OUT OF THE LEFT MAIN ARTERY. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16031952 ↗