EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R17USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013727), received between Apr 29, 2018 and Dec 12, 2019 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL CASE REPORT WAS OBTAINED ON NOV. 17, 2019 AND INCLUDED THE FOLLOWING "DESCRIPTION AS REPORTED": "AS REPORTED BY THE SALES REP, PATIENT CAME IN WITH A STEMI ON (B)(6) 2019 DUE TO IN STENT THROMBOSIS. PATIENT WAS ON BRILINTA AND WENT OFF DUE TO FINANCIAL REASONS. AFTER PROCEDURE THE PATIENT WAS PUT ON PLAVIX. IT IS UNKNOWN IF THE PATIENT'S DOSAGE WAS CORRECT FOR PLAVIX OR IF THE PATIENTS BODY DIDN'T RESPOND TO THE MEDICATION AS WELL AS IT WASN'T IN THE PATIENTS SYSTEM LONG ENOUGH AFTER THE PROCEDURE WHICH COULD HAVE CAUSED THE ELUNIR STENTS TO SHUT DOWN. BOSTON SCI SYNERGY STENTS WERE PLACED IN THE MID CIRC AND MID LAD." IN ADDITION, THE INFORMATION DETAILED IN 'PRODUCT INFORMATION' IN THE SAME REPORT INCLUDED FOUR (4) PRODUCTS. THERE HAVE BEEN SEVERAL ATTEMPTS TO GET INFORMATION ABOUT WHICH PRODUCT WITHIN THE REPORTED FOUR (4) WAS INVOLVED, BUT NO ANSWER HAS BEEN RECEIVED ON THIS MATTER. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON DEC 3, 2019 STATED AS FOLLOWS: THE DEVICE STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE PREP AS PER THE IFU. 1 STENT IN MID CIRC AND 1 STENT IN MID LAD NONE WERE

  Patient problems: Thrombosis

  MAUDE report 9458164 ↗
• MalfunctionApr 29, 2018Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  DESCRIPTION AS REPORTED: "STICKY BALLOON". BALLOON WOULD NOT RE I'VE EASILY AFTER DEPLOYMENT, EVEN AFTER BALLOON WAS DEFLATED. NO PATIENT INJURY. DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471372 ↗