Resolute Onyx™ RONYX20012WRecalls & reported problems
Medtronic, Inc. · STENT RONYX20012W RESOLUTE ONYX 2.00X12 · Class 3 · Implant
All models of Resolute Onyx (101)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169602151), received between Dec 21, 2020 and Dec 21, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2020Material Deformation; Material Deformation
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. IT WAS REPORTED THAT SEVERAL ATTEMPTS TO CROSS THE LESION FAILED. IT WAS STATED THAT THE STENT WAS REMOVED AND RAISED STRUTS WERE NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT OF THE SAME SIZE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11044671 ↗
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- 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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