Resolute Onyx™ RONYX50022UXRecalls & reported problems
Medtronic, Inc. · STENT RONYX50022UX RESOLUTE ONYX 5.00X22 · Class 3 · Implant
All models of Resolute Onyx (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169557321), received between Oct 1, 2020 and Sep 15, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Myocardial Infarction2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN THE CAROTID. THE DEVICE WAS USED PAST ITS EXPIRY DATE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15430641 ↗InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING AN INDEX PROCEDURE TWO RESOLUTE ONYX DES WAS IMPLANTED. APPROXIMATELY 1 DAY POST INDEX PROCEDURE THE PATIENT SUFFERED AN MI. NO ASSESSMENT WAS MADE BY THE SPONSOR OR THE INVESTIGATOR.
Patient problems: Myocardial Infarction
MAUDE report 10611842 ↗InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING AN INDEX PROCEDURE TWO RESOLUTE ONYX DES WAS IMPLANTED. APPROXIMATELY 1 DAY POST INDEX PROCEDURE THE PATIENT SUFFERED AN MI. NO ASSESSMENT WAS MADE BY THE SPONSOR OR THE INVESTIGATOR.
Patient problems: Myocardial Infarction
MAUDE report 10611830 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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