Resolute Onyx™ RONYX45018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169557253), received between Aug 16, 2017 and Mar 3, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX CORONARY BALLOON AND ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE TP TRUNK VESSEL WHICH EXHIBITED MODERATE TORTUOSITY, MILD CALCIFICATION AND 65% STENOSIS. THE NC EUPHORA COULD NOT LOAD ONTO THE GUIDEWIRE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE WAS NOT USED IN THE PATIENT. THE RESOLUTE ONYX STENT DISLODGED IN VIVO DURING DELIVERY TO/AT LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DE LIVERY. THE DISLODGED STENT REMAINED PARTIALLY ON THE BALLOON. THE STENT AND BALLOON WERE REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494604 ↗
• InjuryApr 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE OSTIUM OF THE CIRCUMFLEX (CX) ARTERY. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION AND WAS LATER FOUND IN THE LEFT PROFUNDA. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. IT WAS STATED THAT RESOLUTE ONYX STENTS WERE ALSO PLACED IN THE LEFT MAIN AND OSTIAL RIGHT CORONARY ARTERY, BOTH OF WHICH HAD SUCCESSFUL DEPLOYMENT. THE PATIENT WAS STABLE DURING THE CASE.

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

  MAUDE report 14247851 ↗
• InjuryJul 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) LOCATED IN THE OSTIUM RIGHT CORONARY ARTERY (RCA). 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. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12148750 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD AND RCA. APPROXIMATELY 21 MONTHS POST PROCEDURE, PATIENT SUFFERED HEMORRHAGIC SHOCK DUE TO GI BLEED AND WAS TREATED WITH BLOOD TRANSFUSION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9626497 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED INTO THE RCA. ONE THE SAME DAY, THE PATIENT SUFFERED ANTERIOR MI. THE MI OCCURRED IN A NON TARGET VESSEL AND WAS TREATED WITH PCI OF A NON TARGET VESSEL. POSSIBLE THROMBUS WAS REPORTED. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 8217064 ↗
• MalfunctionJul 17, 2018Difficult to Advance; Material Deformation; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT MAIN ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS NOT PERFORMED. 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. IT WAS REPORTED THAT THE STENT WAS ADVANCED THROUGH A NON-MEDTRONIC GUIDE EXTENSION CATHETER TO PROXIMAL/MID LEFT MAIN. DIFFICULTY DUE TO CALCIFICATION AND LESION CROSSABILITY WAS NOTED. THE STENT WAS REMOVED TO INSPECT THE STENT PRIOR TO CROSSING AGAIN AND IT WAS NOTED THAT STENT STRUT DEFORMATION OCCURRED. THE PROCEDURE WAS COMPLETED USING A MEDTRONIC STENT WITHOUT ANY ISSUES. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

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

  MAUDE report 7693284 ↗
• InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA. ON THE SAME DAY THE PATIENT SUFFERED RIGHT CORONARY ARTERY INTRAMURAL HEMATOMA. A REVASCULARIZATION OF THE TARGET VESSEL WAS CARRIED OUT TO TREAT IN STENT RESTENOSIS <(>&<)> ACUTE THROMBOSIS. THREE RESOLUTE ONYX STENTS WERE IMPLANTED IN THE RCA. THE PATIENT RECOVERED. THE INVESTIGATOR HAS ASSESSED THAT THE EVENT IS UNLIKELY TO BE RELATED TO THE DEVICE AND NOT RELATED TO ANTIPLATELET/ ANTICOAGULANT MEDICATION.

  Patient problems: Hematoma; Occlusion; Stenosis; Thrombus

  MAUDE report 7397339 ↗
• InjuryAug 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN WAS ATTEMPTING TO TREAT A LESION IN THE PROXIMAL LAD USING RESOLUTE ONYX. IT WAS REPORTED THAT PERFORATION OF THE LAD OCCURRED DURING PROCEDURE. PHYSICIAN DID NOT ATTRIBUTE THE PERFORATION TO THE STENT BUT TO THE PLAQUE BURDEN GETTING PUSHED THROUGH THE VESSEL WALL. WHEN PROXIMAL LAD PERFORATION WAS OBSERVED, A NON MEDTRONIC STENT WAS DEPLOYED TO SEAL THE PERFORATION. THE NC EUPHORA WAS USED TO POST DILATE THE NON MEDTRONIC STENT. THE NC EUPHORA BALLOON WOULD NOT CROSS FAR ENOUGH INTO THE NON MEDTRONIC STENT TO POST DILATE. PHYSICIAN COMMENTED THAT THERE WAS SOMETHING WRONG WITH THE NC EUPHORA BALLOON, AS THE STENT WAS FULLY DEPLOYED AND APPEARED TO BE NO REASON WHY THE BALLOON SHOULD NOT CROSS. THE NC EUPHORA BALLOON WAS REMOVED AND AN NC NON MEDTRONIC DEVICE WAS USED TO SUCCESSFULLY POST DILATE. THE RESOLUTE ONYX DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT THE NC EUPHORA PASSED THROUGH A PREVIOUSLY DEPLOYED STENT (RESOLUTE ONYX). THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX DEVICE AND NO EXCESSIVE FORCE DURING DELIVERY, BUT THE NC EUPHORA ENCOUNTERED RESISTANCE WHILE ADVANCING WITH NO EXCESSIVE FORCE USED DURING DELIVERY. FOR BOTH THE RE

  Patient problems: Perforation of Vessels

  MAUDE report 6797274 ↗