EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R28USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013994), received between Apr 29, 2018 and Jul 9, 2018 — classified as 2 malfunctions.

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.

• MalfunctionJul 9, 2018Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  THE EVENT TOOK PLACE ON (B)(6) 2018. THE PHYSICIAN PLACED THE STENT MOUNTED BALLOON CATHETER INTO THE PROX LAD AND WHEN HE WENT TO DEPLOY THE STENT THE BALLOON WOULD NOT HOLD CONSISTENT PRESSURE. IT DID INFLATE ENOUGH TO DEPLOY THE STENT AND HE POST DILATED WITH THE SAME BALLOON TO ENSURE DEPLOYMENT, BUT IT DID THE SAME THING. IT ALSO WOULD NOT DEFLATE COMPLETELY. ONCE THE BALLOON CATHETER WAS OUTSIDE THE BODY AND THE STAFF MADE SURE THE STENT WAS DEPLOYED IN THE PROPER PLACE, THEY CHECK THE BALLOON. UPON INSPECTION, THEY OBSERVED THE BALLOON WAS INTACT (NOT RUPTURED) BUT THEY NOTICED A SMALL LEAK WHERE THE BALLOON CATHETER IS MOUNTED ONTO THE WIRE SHAFT. IT WAS VISIBLE WHEN THE BALLOON WAS INFLATED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON MAY 27, 2018: THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THE RX PORT APPEARED NORMAL. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. NEITHER THE PRODUCT, NOR ANY OF THE OTHER DEVICES USED WITH IT, HAD BEEN RE-STERILIZED. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669089 ↗
• MalfunctionApr 29, 2018Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471371 ↗