EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R15USRecalls & reported problems
Medinol Ltd. · Class 3 · Implant
All models of EluNIR Ridaforolimus Eluting Coronary Stent System (27)
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 07290107013710), received between Mar 30, 2020 and Mar 30, 2020 — classified as 1 injury.
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
Patient problems
- Angina1
- Chest Pain1
- Myocardial Infarction1
- Stenosis1
- Sweating1
- Thrombosis1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL CASE DETAILS WERE RECEIVED AS PART OF THE INVESTIGATION BY MEDINOL'S CLINICAL TRIALS PROJECT MANAGER: CORRECTION TO (B)(6) 2019 EVENT NARRATIVE: INFERIOR WALL MI - STENT THROMBOSIS WAS DEMONSTRATED IN THE RIGHT CORONARY ARTERY AT THE POINT WHERE THERE ARE 2 PREVIOUS STENTS (ELUNIR& ANOTHER BRAND). THE SUBJECT WAS TREATED WITH PTCA BALLOONS WITHOUT A STENT. A GOOD ANGIOGRAPHIC OUTCOME WAS OBTAINED, WITH NORMAL FLOW IN THE ARTERY. FOLLOW-UP BAIM MEDICAL SAFETY ASSESSMENT:STENT THROMBOSIS RESULTING IN TARGET LESION REVASCULARIZATION POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ANTICIPATED. ADDITIONAL INFORMATION: ON (B)(6) 2019, THIS SUBJECT EXPERIENCED UNSTABLE ANGINA. CATHETERIZATION IN (B)(6) 2019 SHOWED PATENT STENTS IN LCX AND LAD, INSIGNIFICANT STENOSIS IN OSTIAL LAD; DISTAL EDGE DISSECTION WAS DEMONSTRATED IN OSTIAL RCA AT THE END OF THE STENT. PTCA WITH A BALLOON WAS PERFORMED, AND A STENT WAS IMPLANTED IN THE MIDDLE RCA SEGMENT. THIS STENT WAS NOT MEDINOL'S STENT. THIS EVENT WAS ASSESSED BY THE PI AS NOT RELATED TO THE DEVICE BUT TO THE PROCEDURE. HOWEVER THE MM (MEDICAL MONITOR) ASSESSED THIS AS POSSIBLE RELATED TO DEVICE AND PROCEDURE -
Patient problems: Angina; Chest Pain; Myocardial Infarction; Stenosis; Sweating; Thrombosis; Vascular Dissection
MAUDE report 9897900 ↗
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.
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