EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R15USRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013864), received between Dec 17, 2019 and Dec 18, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
- Failure to Advance1
- Off-Label Use1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2019Off-Label Use; Failure to Advance; Device Damaged by Another Device; Off-Label Use; Failure to Advance; Device Damaged by Another Device
INITIAL CASE DETAIL REPORT RECEIVED FORM CORDIS ON NOV 24, 2019 HAVE STATED THE FOLLOWING: AS REPORTED, THE DR WAS PUSHING THE STENT IN THE LEFT PT ARTERY AND THE ELUNIR STENT GOT CAUGHT ON A SMART STENT STRUT AND CAME OFF THE BALLOON. THE DR WAS ABLE TO SMASH THE ELUNIR STENT WITHIN THE OTHER STENT AND THERE WAS NO ISSUE OR INJURY FOR THE PATIENT. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9488738 ↗InjuryDec 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS THE PHYSICIAN WAS PUSHING THE 4.0X15 ELUNIR STENT IN THE LEFT POSTERIOR TIBIAL (PT) ARTERY, THE DEVICE GOT CAUGHT ON A SMART STENT STRUT AND CAME OFF THE BALLOON. THE PHYSICIAN WAS ABLE TO SMASH THE ELUNIR STENT WITHIN THE OTHER STENT AND THERE WAS NO ISSUE OR INJURY FOR THE PATIENT. (B)(4).
Patient problems: No Code Available
MAUDE report 9483069 ↗
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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