EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R20USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107013635), received between May 3, 2018 and May 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMay 3, 2018Material Deformation; Material Deformation

  THE TECH REMOVED STENT FROM STERILE PACKAGING. UPON EXAMINING THE STENT BEFORE INSERTION, THE TECH NOTICED THAT STENT HAD A MALFORMATION. A STENT STRUT HAD FRACTURED AND WAS STICKING OUT FROM BODY OF THE STENT. THE PHYSICIAN TOOK A CLEAN DRY GAUZE AND RAN IT BACK THE STENT TO SEE IF THE STRUT WAS PART OF THE STENT. THE MALFORMATION STRUT GRABBED THE GAUZE AND THE PHYSICIAN DID NOT USE THE STENT. ADDITIONAL INFORMATION RECEIVED ON APRIL 11TH, 2018: NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DURING PREPARATION. THE TECH DID NOT TOUCH THE STENT AREA. THE STENT WAS DAMAGED APPROXIMATELY IN THE MIDDLE OF IT. THE PRODUCT WAS STORED PROPERLY, ACCORDING TO IFU. THE PACKAGING WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482397 ↗