EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R15USRecalls & 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 07290107013611), received between Jul 12, 2018 and Jul 12, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
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.
MalfunctionJul 12, 2018Difficult to Remove; Difficult to Remove
INITIAL DESCRIPTION OF THE EVENT AS RECEIVED ON (B)(6)2018: DURING A CASE OBSERVATION, THE BALLOON ON THIS ELUNIR STENT FAILED TO RELEASE FROM THE STENT/WIRE AFTER FULL DEFLATION. THE PHYSICIAN THEN REINFLATED THE BALLOON TO 3ATM AND DEFLATED THE BALLOON ONCE AGAIN. THIS TIME THE BALLOON RELEASED FROM THE STENT AND WAS ABLE TO BE REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2018:THE DEVICE IS NOT AVAILABLE TO RETURN AS IT WAS NOT SAVED POST PROCEDURE. ADDITIONAL INFORMATION WAS ALSO RECEIVED ON (B)(6)2018 AND ON (B)(6)2018 (BOTH REPORTED IN THE INITIAL MDR DATED (B)(6)2018). AS NOTIFIED BY THE DISTRIBUTOR ON (B)(6)2018, ONLY THE INFORMATION RECEIVED ON JUNE 27, 2018 IS THE CORRECT INFORMATION. THIS INFORMATION APPEARS BELOW: THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DEVICE HAS BEES STORED IN THE CATH LAB. IN THE LAB, THE DEVICE HAS BEEN STORED ON A SHELF PLACED UPRIGHT ON AN EDGE WITH THE PRODUCT INFO FACING OUTWARD. NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE PREPARATION OF THE STENT DELIVERY SYSTEM WAS DONE ACCORDING TO THE IFU. THE PHYSICIAN DID NOT CHECK WHETHER THERE WAS ANY DAMAGE TO THE STENT DELIVERY SY
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7682615 ↗
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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