Resolute Onyx™ RONYX25026WRecalls & reported problems
Medtronic, Inc. · STENT RONYX25026W RESOLUTE ONYX 2.50X26 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169602359), received between May 24, 2021 and May 24, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL/ OSTIUM LM/LAD ARTERY WITH 90-95% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PREDILATED WITH A 2.5MM X 15 BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. A SMALL BALLOON WAS INSERTED TO RETRIEVE DISLODGED STENT HOWEVER WAS UNSUCCESSFUL. A SNARE WAS THEN USED TO RETRIEVE STENT WITHOUT SUCCESS. THE PATIENT WAS HEMODYNAMICALLY STABLE WHEN TRANSFERRED TO ANOTHER FACILITY TO RETRIEVE THE STENT AND FINISH THE PROCEDURE.
Patient problems: Unspecified Tissue Injury
MAUDE report 11869539 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page