EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R33USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107013963), received between May 16, 2018 and May 16, 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

Recent adverse event reports

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

• MalfunctionMay 16, 2018Difficult to Remove; Difficult to Remove

  A CASE WAS REPORTED IN WHICH THE SPRING TIP STRETCHED OUT WHILE TAKING OUT THE BALLOON, AFTER A 4.0 X 33 DEPLOYMENT. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 27, 2018: THE TARGET LESION WAS IN THE MID RIGHT CORONARY ARTERY (RCA), THE LESION WAS TIGHT AND SEVERELY TORTUOUS, CALCIFICATION UNKNOWN. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE IFU. NO DAMAGE TO THE PRODUCT PACKAGING WAS NOTED UPON INSPECTION PRIOR TO USE. NO DIFFICULTY WAS REPORTED REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICE WAS PREPPED ACCORDING TO IFU. NO ANOMALY WAS NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RE-STERILIZED. THE GUIDEWIRE PORT WAS FLUSHED AS OUTLINED IN THE IFU PRIOR TO LOADING ON THE GUIDEWIRE. SIZE SHEATH USED WAS 6 AND GUIDE WIRE 0.014. PRIOR TO INSERTING THE STENT DELIVERY SYSTEM (SDS) IN THE CATHETER, THE BALLOON WAS NOT INFLATED OR PARTIALLY INFLATED. NEGATIVE PRESSURE WAS APPLIED TO THE SDS. THE BALLOON WAS STICKING AND DIFFICULT TO REMOVE FROM THE PATIENT, IT TOOK A COUPLE OF ATTEMPTS. WHEN THE SPRING WAS COMING OUT OF THE SHEATH, THE PHYSICIAN NOTICED THAT SOMETHING SEEMED WRONG,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7517499 ↗