Esprit™ 1203375-28Recalls & reported problems
Abbott Vascular Inc. · Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 28mm 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 08717648357152), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Obstruction/Occlusion1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the procedure was to treat an occlusion in the distal posterior tibial artery. The 3.75x28mm Esprit BTK scaffold was implanted; however, a flow-limiting dissection was noted, resulting in worsening of the stenosis severity. Therefore, post dilatation was performed which improved the dissection. No additional information was provided.
Patient problems: Obstruction/Occlusion; Vascular Dissection
MAUDE report 50484667 ↗
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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