Resolute Onyx™ RONYX35026WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169602625), received between Jun 29, 2018 and Mar 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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

• MalfunctionMar 18, 2025Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Device Contamination with Chemical or Other Material; Material Deformation; Positioning Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Device Contamination with Chemical or Other Material; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT FAILED TO CROSS THE LESION. THE LESION BEING TREATED WAS NON-CALCIFIED LESION, MILDLY TORTUOUS WITH 0% STENOSIS, IN THE OSTIUM OF THE PATENT DUCTUS ARTERIOSUS (PDA). THE PROCEDURE AIMED TO STENT THE ENTIRE LENGTH OF THE PDA TO ALLOW THE INFANT PATIENT TO GROW BEFORE UNDERGOING HEART REPAIR SURGERY AT A LATER DATE. THE DEVICE WAS INSPECTED PRIOR TO USE, AND NEGATIVE PREP WAS PERFORMED 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS DETAILED THAT THE STENT COULD NOT ADVANCE TO THE SITE BECAUSE THE PLASTIC PIECE ON THE BALLOON CATHETER WOULD NOT RETRACT FULLY TO THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT AND AN ATTEMPT WAS MADE TO TRY AND REMOVE THE PLASTIC PIECE OVER THE STENT; HOWEVER, IT WOULD NOT COME OFF AND THE ATTEMPT LED TO THE STENT KINKING. THE STENT WAS DAMAGED AFTER IT WAS REMOVEDFROM THE BODY AND ATTEMPTS WERE MADE TO REMOVE THE PLASTIC PIECE. THE DEVICE WAS THEN UNUSABLE. IT WAS STATED THAT THE PLASTIC PIECE WAS NOT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630436 ↗
• InjuryJun 29, 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 MID LAD. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A CARDIAC ARREST IN THE LAD . THIS WAS TREATED WITH ONE DRUG ELUTING STENT . THE PATIENT RECOVERED. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX DEVICE OR ANTI PLATELETS. SAFETY ASSESSMENT REPORTED THAT THE EVENT IS NOT RELATED TO THE PROCEDURE.

  Patient problems: Myocardial Infarction; Patient Problem/Medical Problem

  MAUDE report 7649486 ↗