Resolute Onyx™ RONYX30038WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169602564), received between Jul 16, 2018 and Jan 30, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• InjuryJan 30, 2025Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN IT WAS ATTEMPTED TO CROSS AN IN-STENT RESTENOSIS (ISR) LESION WITH ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT, THE STENT KICKED BACK TO THE GUIDE CATHETER, WHERE THE GUIDE PUSHED THE STENT OFF THE BALLOON AND THE DISTAL END OF THE DELIVERY SYSTEM. AN UNSUCCESSFUL ATTEMPT WAS MADE TO PULL THE STENT BACK INTO THE GUIDE CATHETER. THE STENT DELIVERY SYSTEM (SDS), GUIDE CATHETER, AND WIRE WERE WITHDRAWN TO THE GROIN SITE WHERE EVERYTHING WAS REMOVED AS ONE UNIT INCLUDING THE SHEATH. HOWEVER, THE STENT DISLODGED IN THE RIGHT FEMORAL ARTERY AND ACCESS WAS LOST. CINE IMAGE OF THE RIGHT GROIN SHOWED THAT THE DISLODGED STENT HAD MOVED TO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA)/PROFUNDA AND IT WAS DECIDED TO LEAVE THE STENT IN PLACE. THE LESION BEING TREATED WAS IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, 90% STENOSIS AND TIMI FLOW 3. A SECONDARY LESION WAS PRESENT IN THE PROXIMAL RCA WITH 50% STENOSIS AND TIMI FLOW 3. THE STENT WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP ARATION WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. ACCESS WAS THEN OBTAINED ON THE LEFT FEMORAL ARTERY,

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

  MAUDE report 21272024 ↗
• MalfunctionJun 7, 2022Leak/Splash; Activation, Positioning or Separation Problem; Material Deformation; Leak/Splash; Activation, Positioning or Separation Problem; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. 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 THE DISTAL PART OF THE STENT LOOKED DISFIGURED AFTER STENT DEPLOYMENT. THERE WAS NO CALCIUM OR PLAQUE NOTED AT THE SITE OF DISTORTION TO EXPLAIN THE DISTORTION. IT WAS ALSO REPORTED THAT THE STENT WAS DEPLOYED BUT THE DISTAL PART OF THE STENT DID NOT SEEM FULLY APPOSED DUE TO DISFIGURATION. IT WAS NOTED THAT THE PRESSURE DIDN¿T SEEM AS HIGH AS NORMAL WHEN PREPPING. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14619494 ↗
• MalfunctionFeb 10, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE BALLOON BURST/LEAKED DURING STENT DEPLOYMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307281 ↗
• MalfunctionJul 16, 2018Material Deformation; Physical Resistance/Sticking

  ONE RESOLUTE ONYX DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A SEVERELY CALCIFIED LESION IN THE RCA WITH 80% DIFFUSE MID-ARTERY OCCLUSION WITH THROMBOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 2.0MM X 20MM BALLOON. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND WHEN REMOVED WAS NOTED TO BE DEFORMED. THE LESION WAS THEN PRE-DILATED WITH A 3.0MM X 20MM BALLOON, GUIDELINER WAS ADVANCED AND A 3.0MM X 38MM ONYX STENT WAS SUCCESSFULLY PLACED FOLLOWED BY A MORE PROXIMAL 3.0MM X 38MM ONYX STENT AND THEN ANOTHER 3.50MM X 30MM ONYX WAS PLACED IN THE PROXIMAL SEGMENT IN THE RCA. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7689038 ↗