EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R33USRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107013581), received between Mar 11, 2019 and Mar 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2019Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
THE INITIAL COMPLAINT RECEIVED FROM THE DISTRIBUTER: "AFTER PRE-DILATION OF THE CIRCUMFLEX ARTERY, THERE WAS AN ATTEMPT TO INFLATE THE BALLOON. THE PHYSICIAN SAW THAT THE BALLOON DID NOT INFLATE AND DID NOT RESPOND PROPERLY TO NOMINAL PRESSURE AND IN PARALLEL THE CONTRAST MATERIAL LEAKED OUT OF THE DISTAL PORTION OF THE SHAFT. THERE WAS NO TEAR VISIBLE IN THE BALLOON ITSELF. IT WAS DECIDED AT THIS STAGE TO INSERT ANOTHER BALLOON AND INFLATE THE STENT. THE STENT WAS SUCCESSFULLY OPENED AND IMPLANTED. NO HARM WAS DONE TO THE PATIENT". ADDITIONAL INFORMATION WAS RECEIVED ON MAR. 4TH, 2019 AND ON MAR. 5TH 2019: THE LESION WAS CALCIFIED AND THERE WASN'T ANY VESSEL TORTUOSITY. GUIDING CATHETER XB3.5 6F CORDIS WAS USED. FILDER ASAHI 0.014 GUIDE WIRE WAS USED. THE SDS WAS WASHED FOR RELEASE OF AIR ACCORDING TO THE IFU. THERE WEREN'T ANY LEAKS OR BUBBLES OBSERVED. NO EXCESSIVE FORCE WAS APPLIED ON THE STENT DELIVERY SYSTEM WHILE INSERTING IT OVER THE GUIDE WIRE. A GUIDELINER OR OTHER GUIDE EXTENSION SYSTEM WAS USED. A BUDDY-WIRE WAS NOT USED, THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THERE WASN'T ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER OVER T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8406874 ↗
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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