Resolute Onyx™ RONYX30022WRecalls & reported problems
Medtronic, Inc. · STENT RONYX30022W RESOLUTE ONYX 3.00X22 · Class 3 · Implant
All models of Resolute Onyx (101)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169602526), received between Aug 29, 2019 and May 7, 2021 — classified as 1 injury, 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Burst Container or Vessel1
- Leak/Splash1
Patient problems
- Death1
- Myocardial Infarction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11788948 ↗InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS USED TO TREAT THE LAD. APPROXIMATELY 5.5 MONTHS POST PROCEDURE PATIENT SUFFERED FATIGUE AND DIZZINESS. THE PATIENT DIED ONE DAY LATER. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND UNLIKELY TO THE ANTI-PLATELET MEDICATION.
Patient problems: Death; Myocardial Infarction
MAUDE report 8944078 ↗
Other Coronary drug-eluting stent devices
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- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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