Resolute Onyx™ RONYX50030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169557345), received between Sep 25, 2018 and Feb 24, 2022 — classified as 4 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A NON CALCIFIED LESION DURING AN UNPLANNED PCI PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT FAILED TO PASS THOUGH THE END OF A 6F NON-MEDTRONIC GUIDE EXTENSION CATHETER AND WHEN REMOVED IT WAS NOTED THAT THE STENT HAD DISLODGED AND WAS HUNG UP ON THE PROXIMAL PORTION OF THE GUIDE EXTENSION CATHETER. IT WAS STATED THAT THE STENT NEVER EXITED THE GUIDE EXTENSION CATHETER. THE PROCEDURE WAS COMPLETED USING A LONGER 6F NON-MEDTRONIC GUIDE EXTENSION CATHETER AND ANOTHER MEDTRONIC STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591316 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 33 MONTHS POST PROCEDURE PATIENT SUFFERED GASTROINTESTINAL BLEED. GI BLEEDING WAS SUSPECTED AS THE PATIENT HAD A DARK TARRY STOOL. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE EVENT WAS TREATED WITH COLONOSCOPY AND BLOOD TRANSFUSION. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11601091 ↗
• MalfunctionOct 19, 2020Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A CALCIFIED MID RCA. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION, AND WAS NOTED TO BE DAMAGED UPON REMOVAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10695831 ↗
• 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 DES WERE IMPLANTED IN THE RCA. ON THE SAME DAY, PCI RELATED MI WAS REPORTED. NO ACTION WAS TAKEN. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8216256 ↗
• InjuryDec 17, 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. IT WAS REPORTED THAT DURING THE PROCEDURE, A DISSECTION OCCURED IN THE RCA, THIS WAS TREATED WITH THE IMPLANTATION OF A RESOLUTE ONYX DES. IT IS UNKNOWN IF A MEDTRONIC DEVICE CAUSED THE DISSECTION.

  Patient problems: Intimal Dissection

  MAUDE report 8168632 ↗
• InjurySep 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND HIGHLY CALCIFIED LESION WITHIN THE SAPHENOUS VEIN GRAFT EXHIBITING 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING DEVICE FROM THE HOOP. 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 THE STENT WAS ATTEMPTED TO BE DELIVERED TO THE LESION. IT WOULD NOT CROSS AND UPON REMOVAL FROM THE ARTERY THE STENT EDGE CAUGHT ON THE EDGE OF THE GUIDE CATHETER AND SHEARED OFF AND DISLODGED. IT WAS NOTICED IMMEDIATELY AND THE STENT WAS SNARED AND REMOVED SUCCESSFULLY WITH NO PATIENT INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7904715 ↗