Resolute Onyx™ RONYX30015WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169602502), received between Jan 27, 2020 and Jan 14, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 4 most recent of 4 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 13256999 ↗
• MalfunctionNov 2, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE TWO RESOLUTE ONYX DES WERE USED TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUE REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES. THE LESION WAS PRE DILATED. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE BALLOON BURST AT 12 ATM DURING STENT DEPLOYMENT. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 10769378 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED. ONE DAY POST INDEX PROCEDURE THE PATIENT SUFFERED AN MI. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED TO PREVENT INJURY OR IMPAIRMENT TO THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE PRODUCT, THERAPY OR PROCEDURE. THE CEC IDENTIFIED THE EVENT AS AN MI. .

  Patient problems: Myocardial Infarction

  MAUDE report 10447218 ↗
• InjuryJan 27, 2020Migration or Expulsion of Device; Difficult to Remove; Device Dislodged or Dislocated; Migration or Expulsion of Device; Difficult to Remove; Device Dislodged or Dislocated

  A RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE PATIENT WAS THEN SENT TO SURGERY TO REMOVE THE DISLODGED STENT.

  Patient problems: Injury

  MAUDE report 9630995 ↗