EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R17USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107013628), received between Dec 4, 2019 and Dec 4, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INITIAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2019 HAVE INDICATED THE PHYSICIAN HAVE ATTEMPTED TO USE THE SYSTEM RECENTLY AND THE SHAFT KINKED DURING INSERTION. THERE WAS NO PATIENT INJURY, AND HE FINISHED THE CASE WITH ANOTHER STENT. FURTHER INFORMATION WAS AVAILABLE IN THE DETAILED COMPLAINT REPORT RECEIVED ON (B)(6) 2019 AS FOLLOWS: "AS REPORTED BY THE SALES REP, PLEASE SEND A NEW 2.75X17 ELUNIR TO (B)(6) MEDICAL CENTER 10019386. SEND OVERNIGHT ATTENTION TO (B)(6)/CATH LAB. THE DR. ATTEMPTED TO USE THIS RECENTLY AND THE SHAFT KINKED DURING INSERTION. " THERE WAS NO PATIENT INJURY, AND HE FINISHED THE CASE WITH ANOTHER STENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410117 ↗