Esprit™ (REF 1212375-38)Recalls & reported problems
Abbott Vascular Inc. · Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 38mm Over-The-Wire · Class 3 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648353789), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Ambient Temperature Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 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 3.50 X 38 MM ESPRIT BTK AND 3.75 X 38 MM 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 24780565 ↗
Other Scaffold, infrapopliteal, absorbable devices
- Esprit™ 1203300-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable1 death47 reports
- Esprit™ 1203250-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable37 reports
- Esprit™ 1203350-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable1 death30 reports
- Esprit™ 1203375-38Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable16 reports
- Esprit™ 1203300-28Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable10 reports
- Esprit™Abbott Vascular Inc. · Scaffold, infrapopliteal, absorbable4 reports
- Esprit™ 1203250-28Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable3 reports
- Esprit™ 1203350-18Abbott Vascular Inc. · Scaffold, Infrapopliteal, Absorbable3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.