Esprit™ 1203250-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648357237), received between Aug 1, 2024 and Jul 16, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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. 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.

• MalfunctionJul 16, 2026Improper or Incorrect Procedure or Method; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846461 ↗
• MalfunctionMar 2, 2026Improper or Incorrect Procedure or Method; Ambient Temperature Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT ANTERIOR TIBIAL ARTERY. THE 2.50 X 28 MM ESPRIT BTK SCAFFOLD WAS SUCCESSFULLY IMPLANTED. AFTER DEPLOYMENT, IT WAS OBSERVED THAT THE THERMOALERT TAG WAS NOTED TO BE TRIPPED. IT IS UNKNOWN WHEN THE TAG ALERT SENSOR WAS TRIGGERED AS THE DEVICE WAS NOT STORED IN A TEMPERATURE MONITORED ROOM. 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 24491646 ↗
• MalfunctionAug 1, 2024Break; Material Too Rigid or Stiff; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Advance; Break; Material Too Rigid or Stiff; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PERONEAL ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A 6FR X 45 CM SHEATH AND A 0.014¿ NON-ABBOTT GUIDEWIRE WAS USED IN THE CASE. THE PHYSICIAN ACCESSED THE ANATOMY THROUGH THE RIGHT GROIN AND WENT UP AND OVER THE ILIAC ARCH TO THE LEFT SIDE. IVUS (INTRAVASCULAR ULTRASOUND) WAS USED TO VISUALIZE THE SUPERFICIAL FEMORAL ARTERY (SFA) AND A DRUG COATED BALLOON (DCB) WAS ADVANCED TO THE SFA. ANOTHER IVUS RUN WAS COMPLETED AFTER THE INFLATION OF THE DCB AND EVERYTHING LOOKED GOOD. THE TARGET LESION WAS IN THE PERONEAL ARTERY AND WAS PRE-DILATED WITH A BALLOON DILATATION CATHETER. THE ESPRIT BTK EVEROLIMUS ELUTING BIORESORBABLE SCAFFOLD SYSTEM WAS PREPPED AND INSERTED. THE PHYSICIAN COMMENTED THAT THE DEVICE FELT STIFF AND THERE WAS SOME RESISTANCE EXPERIENCED WHEN ADVANCING. THE DEVICE WAS ADVANCED UP AND OVER THE ILIAC ARCH, BUT ONCE ON THE OTHER SIDE, THERE WAS RESISTANCE AND THE DELIVERY SYSTEM WAS PUSHING THE SHEATH BACK TOWARDS THE AORTA. THE SDS WOULD NOT GO OVER THE ILIAC ARTERY. AFTER MULTIPLE ATTEMPTS, THE SDS WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUE. THE PROCEDURE WAS ENDED. WHEN THE SD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19886947 ↗