EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R24USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013741), received between May 3, 2018 and Oct 25, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INITIAL COMPLAINT DESCRIPTION ((B)(6) 2018, CASE DETAIL REPORT): 3.0X24 ELUNIR WAS DAMAGED DURING IMPLANT AT BWH. EVENT OCCURRED DURING USE. INFORMATION RECEIVED ON (B)(4) 2018 FROM (B)(6) (CASE DETAIL REPORT): COMPONENT NAME: BODY/SHAFT-SDS, MODE AS REPORTED: DAMAGE. THE DEVICE PROBLEM OCCURRED DURING USE. THERE WAS NO INJURY TO PATIENT. THIS WAS A SINGLE USE DEVICE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. THE PATIENT HAD TORTUOSITY, CALCIFICATION AND CTO (CHRONIC TOTAL OCCLUSION) IN UNKNOWN CARDIO VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8004897 ↗
• MalfunctionMay 3, 2018Difficult to Remove; Difficult to Remove

  THE PHYSICIAN DEPLOYED 3 ELUNIR STENTS IN THE PATIENT'S LAD. EACH STENT DELIVERED WITH NO PROBLEM TO THE INTENDED LOCATION. PROX,MID, AND DISTAL LAD. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE BALLOONS AFTER DEPLOYMENT OF THE STENTS, EACH ONE WAS STICKING TO THE STENT AND WAS DIFFICULT TO WITHDRAW. THE PHYSICIAN COMMENTED THAT OUR BALLOONS ARE "STICKY" AND DON'T SEPARATE EASILY FROM THE STENTS ONCE DEPLOYED. IT WAS A PROBLEM. HE HAD TO WIGGLE THEM FOR ABOUT 3 SECONDS EACH AND PULL BACK MORE THAN NORMAL CAUSING THE GUIDE TO ADVANCE. THERE WAS NO PATIENT ISSUES AFTERWARDS. ALL 3 BALLOONS WERE DISCARDED IMMEDIATELY AFTER THE PROCEDURE AND ARE NOT AVAILABLE TO SEND IN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482212 ↗