Esprit™ 1203250-18Recalls & reported problems
Abbott Vascular Inc. · Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 2.50mm x 18mm Rapid-Exchange · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648357213), received between Apr 22, 2025 and Apr 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Failure to Advance1
- Improper or Incorrect Procedure or Method1
- Material Separation1
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.
InjuryApr 22, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. PRE-DILATATION WAS PERFORMED AND THE VESSEL DIAMETER AFTER PRE-DILATATION WAS 2.5 MM. THE 2.50X18MM ESPRIT BTK SYSTEM WAS ADVANCED THROUGH A SHORT 6FR SHEATH UP AND OVER BUT THERE WAS NOT ENOUGH SUPPORT AND THE DEVICE BECAME STUCK. THE PHYSICIAN PULLED HARD TO REMOVE THE SYSTEM; HOWEVER IT SEPARATED AT THE SHAFT. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE SEPARATED PORTION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880796 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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