EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R20USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290107013833), received between Mar 29, 2018 and Jun 20, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2018Inflation Problem; Leak/Splash; Retraction Problem; Inflation Problem; Leak/Splash; Retraction Problem

  THE EVENT TOOK PLACE ON FRIDAY (B)(6). 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 TO HOLD IT IN PLACE, BUT HE BELIEVES THE BALLOON RUPTURED AND HE PULLED NEGATIVE ON IT IMMEDIATELY. HE THEN TRIED TO RE-INFLATE THE BALLOON BUT IT WOULD NOT HOLD PRESSURE. HE STATES HE SAW CONTRAST FLOWING OUT OF THE BALLOON CATHETER. HE THEN REMOVED THE STENT BALLOON AND STATES THAT IT GOT HUNG BRIEFLY ON THE STENT, WHICH HE BELIEVES WAS BECAUSE THE STENT WASN'T FULLY DEPLOYED. HE POST-DILATED WITH A NC BALLOON AND TOOK IT TO 18 ATM AND THE STENT LOOKED TO BE IN THE PROPER PLACEMENT AND THE VESSEL WAS OPEN. ONCE THE BALLOON CATHETER WAS OUTSIDE THE BODY AND THEY MADE SURE THE STENT WAS DEPLOYED IN THE PROPER PLACE, THEY CHECKED THE BALLOON. UPON INSPECTION, THEY OBSERVED A SMALL LEAK WHERE THE BALLOON CATHETER IS MOUNTED ONTO THE WIRE SHAFT. IT IS VISIBLE WHEN TRYING TO INFLATE THE BALLOON. HOWEVER, HE WAS NOT ABLE TO CONFIRM WHETHER THE BALLOON RUPTURED OR NOT. ADDITIONAL INFORMATION, RECEIVED ON JUNE 10, 2018: THE PRODUCT WAS STORED PROPERLY A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7618723 ↗
• MalfunctionApr 18, 2018Difficult to Remove; Difficult to Remove

  DESCRIPTION AS REPORTED: THE STENT BALLOON ON TWO STENTS WAS DIFFICULT TO REMOVE. ACCORDING TO THE PHYSICIAN IT FELT LIKE THE STENT BALLOONS WERE STICKING TO THE STENTS. THE GUIDE WAS MOVING BACK AND FORTH WHEN TRYING TO GET THE STENT BALLOONS OUT. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOONS WITHOUT A REINFLATION. NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON FEB 28, 2018: THE PHYSICIAN COMPLETED THE PROCEDURE AND DEPLOYED THE STENTS; PRESSURES WERE AT LEAST NOMINAL; THE PHYSICIAN DEPLOYED BOTH STENTS; HE HAD A DIFFICULT TIME REMOVING BOTH STENT BALLOONS AFTER DEFLATION; THE STENT SYSTEMS WERE DISPOSED; THE LESION WAS IN THE MLAD AND HEAVILY CALCIFIED (2 PHOTOS OF THE LESION WERE PROVIDED); THE GUIDE HAD NO KINKS; PRE-DILATATION WAS DONE; THE STENTS WERE NOT PREPPED ACCORDING TO IFU; THE TECH ONLY DREW NEGATIVE ONCE; ADDITIONAL INFORMATION RECEIVED ON MAR 11, 2018: THE GUIDE WAS A VISTA BRITE TIP, JL3.5. THE CONTRAST WAS MEASURED AND DID NOT SIT LONG PRIOR TO INTERVENING. PRE-DILATATION WAS WITH A NC TREK 3.0X12. THREE INFLATIONS AT 8 ATM FOR ABOUT 15 SECONDS EACH. 1ST ELUNIR 3.5X20 WAS PLACED IN THE MLAD ON THE DISTAL PART OF THE LESION. IT WAS INFLATED FOR 31 S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439130 ↗
• InjuryMar 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE 3.5X20 STENT STRIPPED OFF THE BALLOON, THEN THE PHYSICIAN STRUGGLED TO FIND WHERE THE STENT WENT, THEN ULTIMATELY ONCE FOUND IT, IT WAS WAY PAST TARGET LESION AND HAD TO CRUSH STENT UP AGAINST THE LAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7380751 ↗