EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R12USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107013604), received between Nov 14, 2018 and Nov 14, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• InjuryNov 14, 2018Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  INITIAL CASE DESCRIPTION (RECEIVED FROM CORDIS ON OCT. 23, 2018): DESCRIPTION AS REPORTED: "DR PREDILIATED 90% LESION WITH A SEMI COMPLIANT NEAR OSTIUM OF SVG. PREDILITATION WAS FINE. STENT WAS TAKEN TO LESION, WHEN THE SCRUB TECH TURNED THE INDEFLATOR TWICE, THE BALLOON BURST WITHOUT GOING ANYWHERE CLOSE TO NOMINAL (PERHAPS 2 ATMS. STENT WAS SEVERELY UNDER-DEPLOYED, AND FLOATING ON THE WIRE IN THE SVG. DR WAS ABLE TO REMOVE THE STENT BALLOON AND GO IN WITH AN NC POST DILATATION BALLOON TO OPPOSE THE STENT TO THE WALLS. HE THEN SAW A DISSECTION, TREATED THE DISSECTION WITH A SECOND STENT, AND USED IVUS AT THE END TO ENSURE THAT THE FIRST STENT WAS TRULY OPPOSED. THE PATIENT WAS OK, AND THE RESULT WAS GOOD. HOWEVER; THE STENT BALLOON BURST ALMOST IMMEDIATELY WHEN THE PREDILITATION AND POST DILATATION BALLOONS DID NOT AT ALL, NOR DID THE SECOND ELUNIR THAT THE DOC PLACED" DESCRIPTION SUMMARY: "AS REPORTED, THE PHYSICIAN PRE-DILIATED 90% OF THE LESION WITH A SEMI COMPLIANT BALLOON NEAR THE OSTIUM OF THE SAPHENOUS VEIN GRAFT (SVG). THE ELUNIR (2.75X12 US) STENT WAS TAKEN TO THE LESION; HOWEVER, WHEN THE SCRUB TECH TURNED THE INDEFLATOR TWICE, THE BALLOON BURST AT APPROXIMATELY 2 ATMOSP

  Patient problems: Vascular Dissection

  MAUDE report 8068214 ↗