Resolute Onyx™ RONYX25015WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169602328), received between Dec 11, 2017 and Aug 16, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryAug 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION WHILE ATTEMPTING TO PASS A PREVIOUSLY DEPLOYED STENT. THE DISLODGED STENT WAS CRUSHED IN THE VESSEL USING ANOTHER STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 8900555 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX DRUG ELUTING STENT DEVICES (RONYX25015W AND RONYX22515W) WERE USED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED. THE 2.5X15 MM RESOLUTE ONYX WAS DEPLOYED IN THE MID LAD AT 20 ATM. THEN THE 2.25X15 MM WAS PLACED DISTAL TO THAT AS THERE WAS STILL A SIGNIFICANT LESION, AFTER OVERLAPPING THE FIRST STENT TO 18ATM. THEN THE BALLOON OF THE RESOLUTE ONYX 2.25X15 WAS USED IN THE MIDDLE OF THE OVERLAP AREA AS A POST DILATION TO 20ATM. AT THIS POINT THERE WERE EXCELLENT RESULTS WITH NO RESIDUAL STENOSIS IN THE MID LAD; NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE AND THE PATIENT WAS STABLE AT THAT POINT. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED WITHIN 24 HRS OF THE PROCEDURE BEING PERFORMED. THE THROMBUS WAS

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem; Thrombus

  MAUDE report 7103707 ↗