Resolute Onyx™ RONYX25012WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169602311), received between Jan 3, 2019 and Feb 13, 2024 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Leak/Splash; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 80% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT 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. IT WAS REPORTED THAT THERE WAS A SLOW LEAK. THE STENT WAS IMPLANTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693324 ↗
• MalfunctionSep 19, 2022Leak/Splash; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT 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. IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED THERE WAS A SLOW DRIP OR LEAK AT THE TRANSITION OF THE CATHETER AND THE HUB. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445199 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. IT WAS REPORTED THAT THE PATIENT SUFFERED A SPASM ON THE SAME DAY AS THE INDEX PROCEDURE. IT WAS REPORTED THAT THE VASOSPASM WAS NOT TREATED BUT CONSIDERED SIGNIFICANT BY INVESTIGATOR.

  Patient problems: Occlusion

  MAUDE report 9552497 ↗
• MalfunctionMar 28, 2019Inflation Problem; Inflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THERE WERE INFLATION DIFFICULTIES EXPERIENCED DURING STENT DEPLOYMENT WHILE INFLATING AT 12ATM. ANOTHER INFLATION DEVICE WAS USED TO ATTEMPT INFLATING THE DEVICE HOWEVER IT WOULD STILL NOT INFLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER 2.50X12MM RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459437 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LAD IN A PATIENT. ONE DAY POST INDEX, ELEVATED ENZYMES WERE NOTED WHICH IS REPORTED TO BE RELATED TO MI, THE MI WAS IN A NON TARGET VESSEL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO DEVICE OR TO THE ANTI PLATELET. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 8211802 ↗