Esprit™ (REF 1212350-38)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648353703), received between Mar 6, 2026 and Jun 4, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Ambient Temperature Problem” (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. How this data works · Data updated Oct 13, 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 4, 2026Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANTERIOR TIBIAL ARTERY LESION. A 3.5X38 MM ESPIRIT BTK OTW BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS UNABLE TO BE ADVANCED ALONG THE GUIDE WIRE. AN ADDITIONAL ESPRIT BTK BVS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS INDICATED THAT THE OUTER MEMBER WAS SEPARATED AT THE MID LAP SEAL. THE INNER MEMBER WAS SEPARATED 21 CM PROXIMAL TO THE MID LAP SEAL. THE INNER MEMBER WAS ALSO STRETCHED OUT DISTALLY TO THE NOTED SEPARATION FOR A LENGTH OF 14.4 CM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394123 ↗
• MalfunctionApr 2, 2026Improper or Incorrect Procedure or Method; Ambient Temperature Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. IT WAS NOTED DURING PREPARATION THAT THE TEMPERATURE TAGS ON THE 3.50X38MM ESPRIT BTK AND 3.75X38MM ESPRIT BTK SYSTEMS WERE TRIGGERED. THE DEVICES WERE NOT CORRECTLY STORED IN A TEMPERATURE MONITORED ROOM. THE SCAFFOLDS WERE IMPLANTED IN THE PATIENT WITHOUT ISSUE. 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 24766806 ↗
• MalfunctionMar 6, 2026Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE RIGHT ANTERIOR TIBIAL (AT) ARTERY. THE LESION WAS PREPARED WITH A DIAMONDBACK ATHERECTOMY DEVICE AND BALLOON INFLATIONS. A NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED DUE TO THE CALCIUM. THE 3.50X38MM OTW ESPRIT BTK SYSTEM WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATED TO 16 ATMOSPHERES (ATM) HOWEVER UNDER ANGIO IT WAS NOTED THERE WAS A PORTION OF THE MIDDLE OF THE BALLOON THAT DID NOT INFLATE. INFLATION WAS INCREASED TO 20 ATM HOWEVER THE MIDDLE STILL DID NOT INFLATE. THE SCAFFOLD WAS DEPLOYED THEREFORE THE ESPRIT BTK SYSTEM WAS RETRACTED. THE PHYSICIAN WANTED TO TEST THE BALLOON THEREFORE IT WAS INFLATED IN ANOTHER PART OF THE LESION AND THE BALLOON WAS ABLE TO FULLY INFLATE WITH NO WAIST. THE ESPRIT BTK SYSTEM WAS REMOVED AND THE LESION POST DILATED WITH A NON-COMPLIANT BALLOON. IN THE PHYSICIANS OPINION, THE WAIST WAS DUE TO CALCIUM IN THE LESION AND NOT A BALLOON ISSUE. 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 24531836 ↗