Resolute Onyx™ RONYX40034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169557215), received between Mar 18, 2020 and Dec 10, 2024 — 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.

• InjuryDec 10, 2024Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, THE DISTAL PART OF THE BALLOON WOULD NOT INFLATE THE STENT BUT THE PROXIMAL PART DID INFLATE THE STENT. THE DEVICE MALFUNCTIONED INSIDE THE PATIENT AND EVASIVE ACTION HAD TO BE TAKEN TO SAVE THE CASE. THE STENT WOULD NOT FULLY DEPLOY DUE TO THE BALLOON. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890785 ↗
• InjuryFeb 23, 2021Fracture; Fracture

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). 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. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE FRACTURED. NO DIFFICULTIES WERE NOTED DURING STENT DEPLOYMENT. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. IT WAS STATED THAT THE STENT WAS IMPLANTED AND THE STENT WAS BELIEVED TO BE FRACTURED AFTER DEPLOYMENT. A 5.00 MM RESOLUTE ONYX STENT WAS PLACED INSIDE IN THE FRACTURED STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11364351 ↗
• InjuryMar 18, 2020Adverse 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 LAD. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION. EVENT WAS TREATED WITH MEDICATION. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. CEC ADJUDICATED THE EVENT AS MI (VESSEL UNKNOWN). PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9846843 ↗