EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R15USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107013536), received between Sep 13, 2018 and Sep 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL DESCRIPTION OF EVENT: THE STENT DISLODGED OFF THE PTCA. IT WAS DEPLOYED IN THE LAD. THE PATIENT WAS NOT HURT. ANOTHER STENT WAS USED. ADDITIONAL INFORMATION RECEIVED: INFORMATION RECEIVED FROM CORDIS ON AUG. 21, 2018: THE INTENDED TARGET LESION WAS FIRST DIAG. THE TARGET LESION CHARACTERISTIC WAS: 95% STENOSIS, VERY CALCIFIED AND NOT TORTUOUS. THE DISLODGMENT OCCURRED DURING THE WITHDRAWAL BACK TO THE GUIDE CATHETER. THERE WAS AN ATTEMPT TO INTENTIONALLY DEPLOY THE STENT/INFLATE THE BALLOON. THE SDS IS NOT AVAILABLE FOR INSPECTION, THEY THREW THE PTCA AWAY. THERE WAS NO OTHER PRODUCT ISSUE NOTED EITHER AT THE ACCOUNT, AFTER THE PROCEDURE OR PRIOR TO SHIPPING FOR INSPECTION. PATIENT INFORMATION IS NOT AVAILABLE. THE PRODUCT WAS PREPPED PROPERLY PER THE IFU. THERE WERE NO PROBLEMS NOTED DURING PREPARATION. THE PROCEDURE COMPLETE BY DEPLOYING THE STENT IN THE PROX LAD AND ANOTHER ELUNIR WAS USED IN DISTAL LAD. THE PROCEDURE COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE PRODUCT WAS STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872121 ↗