Resolute Onyx™ RONYX22526WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169602267), received between Dec 13, 2017 and Mar 1, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Leak/Splash; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED, WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 REPORTED THAT LEAK OCCURRED AT THE LUER/HUB AT 12 ATMS. IT WAS DETAILED THAT TWO INFLATIONS WERE APPLIED TO THE DEVICE PRIOR TO THE ISSUE OCCURRING. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815095 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED FOUR RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 100% STENOSIS. ARTERY DIAMETER 2.5 MM AND ARTERY LENGTH 24 MM. THE 2.5 X 18 STENT WAS DEPLOYED AT 18ATM FOR 8 SECONDS AND POST DILATED 3 TIMES IN THE DISTAL OF THE PROXIMAL LAD. THE 2.25 X 26 WAS DEPLOYED AT 18 ATM FOR 8 SECONDS AND POST DILATED 4 TIMES. THE 2.25 X 26 STENT WAS DEPLOYED AT 18 ATM FOR 10 SECONDS AND POST DILATED 5 TIMES, TWENTY (20) ATM FOR 8 SECONDS AND 6 TIMES 20 ATM FOR 6 SECONDS .THE 2.25 X 26 STENTS WERE CONFORMED TO BE DISTAL TO THE 2.5 X 18 HOWEVER, AS THE PATIENT HAD CHEST PAIN HE WAS MOVING AROUND, THE STENTS WERE SEEN TO BE PROXIMAL TO THE FIRST. DURING ANGIOGRAPHY, POST PROCEDURE, THE STENT HAD MOVED PROXIMALLY IN THE LAD. THE 2.25 X 15 WAS DEPLOYED AT 12ATM FOR 8 SECONDS AND POST DILATED 7 AT18 ATM FOR 6 SECONDS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING, AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PR

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7112115 ↗
• InjuryDec 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PHYSICIAN USED FOUR RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 100% STENOSIS. ARTERY DIAMETER 2.5 MM AND ARTERY LENGTH 24 MM. THE 2.5 X 18 STENT WAS DEPLOYED AT 18 ATM FOR 8 SECONDS AND POST DILATED 3 TIMES IN THE DISTAL OF THE PROXIMAL LAD. THE 2.25 X 26 WAS DEPLOYED AT 18 ATM FOR 8 SECONDS AND POST DILATED 4 TIMES. THE 2.25 X 26 STENT WAS DEPLOYED AT 18 ATM FOR 10 SECONDS AND POST DILATED 5 TIMES, 20 ATM FOR 8 SECONDS AND 6 TIMES 20 ATM FOR 6 SECONDS .THE 2.25 X 26 STENTS WERE CONFORMED TO BE DISTAL TO THE 2.5 X 18 HOWEVER, AS THE PATIENT HAD CHEST PAIN HE WAS MOVING AROUND, THE STENTS WERE SEEN TO BE PROXIMAL TO THE FIRST. DURING ANGIOGRAPHY, POST PROCEDURE, THE STENT HAD MOVED PROXIMALLY IN THE LAD. THE 2.25 X 15 WAS DEPLOYED AT 12 ATM FOR 8 SECONDS AND POST DILATED 7 AT 18 ATM FOR 6 SECONDS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING, AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7112109 ↗
• InjuryDec 13, 2017Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  IT WAS REPORTED THAT THE PHYSICIAN USED FOUR RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 100% STENOSIS. ARTERY DIAMETER 2.5 MM AND ARTERY LENGTH 24 MM. THE 2.5 X 18 STENT WAS DEPLOYED AT 18 ATM FOR 8 SECONDS AND POST DILATED 3 TIMES IN THE DISTAL OF THE PROXIMAL LAD. THE 2.25 X 26 WAS DEPLOYED AT 18 ATM FOR 8 SECONDS AND POST DILATED 4 TIMES. THE 2.25 X 26 STENT WAS DEPLOYED AT 18 ATM FOR 10 SECONDS AND POST DILATED 5 TIMES, 20 ATM FOR 8 SECONDS AND 6 TIMES 20 ATM FOR 6 SECONDS .THE 2.25 X 26 STENTS WERE CONFORMED TO BE DISTAL TO THE 2.5 X 18 HOWEVER, AS THE PATIENT HAD CHEST PAIN HE WAS MOVING AROUND, THE STENTS WERE SEEN TO BE PROXIMAL TO THE FIRST. DURING ANGIOGRAPHY, POST PROCEDURE, THE STENT HAD MOVED PROXIMALLY IN THE LAD. THE 2.25 X 15 WAS DEPLOYED AT 12 ATM FOR 8 SECONDS AND POST DILATED 7 AT 18 ATM FOR 6 SECONDS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING, AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7112082 ↗