Esprit™ 1203350-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648357053), received between Dec 2, 2024 and Feb 10, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 16, 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 10, 2026Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. PRIOR TO STENT IMPLANTATION A DISSECTION WAS NOTED, THEREFORE, THE 3.5X18MM ESPRIT BTK SCAFFOLD WAS ADVANCE TO THE TARGET LESION AND THE SCAFFOLD WAS IMPLANTED TO TREAT THE DISSECTION. FOR POST DILATION, A 4X20MM JADE BALLOON WAS ATTEMPTED TO BE USED; HOWEVER, THE TIP OF THE BALLOON INTERACTED WITH THE PROXIMAL END OF THE IMPLANTED SCAFFOLD WHICH COMPRESSED THE SCAFFOLD, AS THE MARKERS OF THE SCAFFOLD WERE NOTED TO CLOSER COMPARED TO WHEN THE SCAFFOLD WAS INITIALLY IMPLANTED. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THERE WAS NO SIGNIFICANT ISSUE WITH THE COMPRESSED SCAFFOLD; HOWEVER, A DISSECTION FLAP WAS STILL NOTED AT THE PROXIMAL END OF THE SCAFFOLD. THEREFORE, A 3.75X18MM ESPRIT BTK SCAFFOLD WAS IMPLANTED TO OVERLAP THE PREVIOUSLY IMPLANTED SCAFFOLD TO TREAT THE REMAINDER OF THE DISSECTION AND DUE TO INITIAL SCAFFOLD BECOMING COMPRESSED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305906 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 3.0X28 MM ESPRIT BELOW THE KNEE (BTK) BIORESORBABLE VASCULAR SCAFFOLD WAS IMPLANTED IN (B)(6) 2025 IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION AND 100% STENOSIS. THE STENT APPEARED OCCLUDED UNDER X RAY FROM (B)(6) 2025. TREATMENT, IF ANY, WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22568936 ↗
• MalfunctionDec 2, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. THE ESPRIT BTK SYSTEM WAS ADVANCED AND THE SCAFFOLD DEPLOYED IN THE TARGET LESION. DURING REMOVAL OF THE SYSTEM OUTSIDE OF THE PATIENT ANATOMY, THE SHAFT BECAME STUCK ON THE GUIDE WIRE. FORCE WAS APPLIED IN THE ATTEMPTS TO REMOVE THE CATHETER AND THE SHAFT SEPARATED ON THE GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824964 ↗