Esprit™ 1203350-28Recalls & reported problems
Abbott Vascular Inc. · Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 28mm Rapid-Exchange · Class 3 · Implant
All models of Esprit (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648357077), received between Nov 19, 2024 and Apr 2, 2026 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance2
- Break1
- Deformation Due to Compressive Stress1
- Difficult to Remove1
- Failure to Advance1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Break; Failure to Advance; Difficult to Advance; Material Split, Cut or Torn
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE TIBIAL ARTERY. THE 3.50X28MM ESPRIT BTK SYSTEM WAS ADVANCED HOWEVER THE STEEP AORTIC BIFURCATION CAUSED THE SHEATH TO BACK OUT OF THE CONTRALATERAL SIDE AND RESISTANCE DURING ADVANCEMENT. THE ESPRIT FAILED TO CROSS THE LESION. ONCE REMOVED IT WAS NOTED THE GUIDE WIRE EXIT NOTCH WAS TORN AND THE SUPPORT SKIVE/WIRE/BAYONET WAS SEPARATED 1 CM DISTAL TO THE OUTER MEMBER TO HYPOTUBE SEAL, HOWEVER, WAS HELD BY THE OUTER MEMBER. 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 24764539 ↗MalfunctionNov 19, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON FEMORAL ARTERY. DURING ADVANCEMENT OF THE 3.50X28MM ESPRIT BTK SYSTEM INTO THE 6FR 45CM SHEATH, THE SHAFT WAS KINKED AND BECAME STUCK IN THE SHEATH. THE SHEATH AND ESPRIT WERE REMOVED TOGETHER. ANOTHER ESPRIT BTK WAS USED TO COMPLETE THE PROCEDURE USING THE SAME SHEATH. 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 20722615 ↗
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™Abbott Vascular Inc. · Scaffold, infrapopliteal, absorbable3 reports
- Esprit™ 1203250-28Abbott 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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