EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R20USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290107013550), received between Jul 15, 2018 and Feb 24, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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.

• InjuryFeb 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACCORDING TO INITIAL REPORT RECEIVED ON JAN. 10TH, 2019, "MID-DISTAL RCA LESION. INITIAL STENT STUCK TO DELIVERY SYSTEM. ATTEMPTED TO PASS A SECOND OF THE SAME SIZE. EVENTUALLY CROSSED W/2.5X28 ELUNIR" THE COMPLAINT WAS CLASSIFIED AS NON-REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON JAN. 23RD, 2019: THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WASN'T ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WASN'T ANY DAMAGE NOTED TO THE PRODUCT UPON INSPECTION PRIOR TO USE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). PRE-DILATION WAS PERFORMED. THE GUIDE WIRE THAT WAS USED DURING THE PROCEDURE WAS A 6F VISTA BRIGHT. NO GUIDELINER OR OTHER GUIDE EXTENSION SYSTEM WAS USED. THE VESSEL WAS CALCIFIED AND TORTUOUS. THERE WEREN'T ANY KINKS/BENDS NOTED IN THE STENT DELIVERY SYSTEMS BEFORE STARTING THE PROCEDURE. THERE WASN'T ANY UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE PROCEDURE COMPLETED SUCCESSFULLY WITH ELUNIR 2.5X28. THERE WASN'T ANY INJURY TO PATIENT. THE STATUS OF THE PATIENT IS STABLE. THE DOCTOR HAD DIFFICULTY TRACKING THE INITIAL ELUNIR STENT DELIVERY SYSTEM. THE INITIAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364959 ↗
• MalfunctionNov 1, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  INITIAL CASE DESCRIPTION (SENT BY CORDIS, 09 OCTOBER, 2018): AFTER COMPLETING CORONARY INTERVENTION, STENT BALLOON CATHETER WAS DIFFICULT TO REMOVE AFTER PLACING ELUNIR STENT IN MID LAD. AFTER DEFLATING STENT BALLOON, WENT TO REMOVE AND WAS A LITTLE DIFFICULT TO GET OUT OF GUIDE CATHETER. THE PHYSICIAN WAS EVENTUALLY ABLE TO REMOVE STENT BALLOON CATHETER AND NO HARM DONE TO PATIENT. USED IFR WIRE, 2.5X20 ELUNIR STENT, AND 6F MEDTRONIC 3.5 EBU CATHETER. TOOK STENT BALLOON UP TO 20 ATM. ADDITIONAL INFORMATION (SENT BY CORDIS, OCTOBER 26, 2018): THE LESION WASN'T CALCIFIED; THERE WAS NO VESSEL TORTUOSITY/ANGULATION. NO PRE-DILATION WAS PERFORMED. NO POST DILATION WAS PERFORMED. NO EXCESSIVE FORCE WAS APPLIED ON THE STENT DELIVERY SYSTEM WHILE INSERTING IT OVER THE GUIDE WIRE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE DURING WITHDRAWAL. A GUIDE LINER WAS USED. A BUDDY-WIRE WASN'T USED. THE BALLOON CATHETER DIDN'T KINK WHILE BEING USED. THE BALLOON CATHETER WAS ABLE TO BE REMOVED. PHYSICIAN STATED IT WAS DIFFICULT TO REMOVE BALLOON CATHETER AFTER DEPLOYMENT. GOT CAUGHT UP IN GUIDE CATHETER. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER OVER T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028128 ↗
• MalfunctionJul 15, 2018Burst Container or Vessel; Difficult to Remove; Retraction Problem; Burst Container or Vessel; Difficult to Remove; Retraction Problem

  THE PHYSICIAN DEPLOYED THE STENT IN DISTAL LAD AT BIFURCATION OF DIAG. STENT WAS DEPLOYED PROPERLY. AFTER DEPLOYMENT, THE PHYSICIAN BROUGHT THE STENT BALLOON UP TO 20 ATM FOR 27 SECONDS FOR A SECOND INFLATION. ON A THIRD INFLATION, HE BROUGHT THE BALLOON UP TO 20 ATM FOR 10 SECONDS. WHEN HE WENT TO REMOVE THE STENT BALLOON DELIVERY SYSTEM, THE BALLOON GOT STUCK AND SPLIT IN HALF. HE REMOVED THE CATHETER BUT THE DISTAL END OF THE SYSTEM (MARKERS AND TIP) WERE STILL ON THE WIRE IN THE ARTERY. HE WAS ABLE TO USE A TRAP TECHNIQUE AND PULL EVERYTHING OUT. A 7F CORDIS VISTA BRITE TIP, 7F GUIDEZILLA, AND A PROWATER WIRE WERE BEING USED AT THE TIME OF THE EVENT. THE BALLOON EITHER BURST OR GOT STUCK ON THE GUIDEZILLA. THE PHYSICIAN RETURNED THE PRODUCT USED. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON JULY 04, 2018: NO EXCESS FORCE WAS USED DURING PREP. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. TARGET LESION CHARACTERISTICS:(B)(4)% STENOSIS, (B)(4) DEGREE TORTUOSITY, THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE PREPARATION OF THE STENT DELIVERY SYSTEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7688849 ↗