Esprit™ (REF 1212250-38)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648353864), received between Dec 17, 2025 and Apr 21, 2026 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025 THREE ESPRIT OTW SCAFFOLDS (SIZES 2.5X38, 3.0X38 (X2) MM) WERE IMPLANTED IN THE PROXIMAL RIGHT ANTERIOR TIBIAL ARTERY. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2026, THE PATIENT HAD BILATERAL CYANOSIS AND NON-PALPABLE PULSES. THE PATIENT WAS SCHEDULED FOR AN ANGIOGRAM TO TREAT A LOWER LIMB ARTERIAL OCCLUSION (STENOSIS) IN ALL THREE INDEX SCAFFOLDS. ON (B)(6) 2026, HE UNDERWENT SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE TARGET ANTERIOR TIBIAL ARTERY, WHICH IMPROVED FROM 100% STENOSIS TO RESTORED PATENCY AND FLOW. THE PROCEDURE RESTORED PERFUSION WITHOUT COMPLICATION, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24944456 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED TOTALLY OCCLUDED LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY. A 2.50X38MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE DISTAL LESION FOLLOWED BY TWO 3.0X38MM IMPLANTED IN THE PROXIMAL LESION. NO ISSUES WERE NOTED DURING DEPLOYMENT OF THE SCAFFOLDS AND ALL THREE WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL. POST IMPLANT, NO FLOW WAS NOTED TO THE FOOT. THE LESION WAS REWIRED AND BALLOON ANGIOPLASTY AND THROMBECTOMY WERE PERFORMED HOWEVER OUTFLOW WAS NOT ABLE TO BE ESTABLISHED. PER THE PHYSICIAN, THERE WAS POSSIBLE EMBOLIZATION FROM THE PROCEDURE OR DISSECTION OF THE DISTAL VESSEL. THE PATIENT REMAINED HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 23827778 ↗