Resolute Onyx™ RONYX35018WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169602601), received between Feb 13, 2019 and Jan 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD FIVE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED. IT WAS ALSO REPORTED THAT, APPROXIMATELY 14 MONTHS AFTER THE PROCEDURE, ONE STENT BECAME OCCLUDED AND WAS REPLACED BY A NON MEDTRONIC STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 13256998 ↗
• InjuryFeb 22, 2019Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION EXHIBITING 80-90% STENOSIS LOCATED IN THE MID LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT FOLLOWING DEPLOYMENT OF THE 3.5X18MM RESOLUTE ONYX, A PERFORATION OCCURRED. A LEAK OF CONTRAST WAS NOTED OVER THE TREATMENT AREA. A NON MEDTRONIC STENT WAS SUCCESSFULLY DEPLOYED OVER THE AREA OF CONCERN AND NO FURTHER CONTRAST LEAK WAS NOTED.

  Patient problems: Perforation

  MAUDE report 8361209 ↗
• InjuryFeb 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUT ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL RCA WITH 90% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PREDILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. AN ATTEMPT WAS MADE TO REMOVE THE STENT USING A SNARE, HOWEVER THIS WAS UNSUCCESSFUL. A 4 X 20MM EUPHORA BALLOON WAS USED TO DEPLOY THE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8334577 ↗