Esprit™ 1203375-18Recalls & reported problems
Abbott Vascular Inc. · Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 18mm 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648357138), received between Aug 21, 2024 and Aug 6, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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. 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
- Adverse Event Without Identified Device or Use Problem1
- Difficult or Delayed Activation1
- Improper or Incorrect Procedure or Method1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Obstruction/Occlusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 3.5X18 MM, 3.5X38 MM, 3.75X18 MM AND A 3.75X38 MM ESPRIT BELOW THE KNEE (BTK) BIORESORBABLE VASCULAR SCAFFOLD WERE IMPLANTED ON (B)(6) 2025 IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION AND 100% STENOSIS. THE STENTS APPEARED OCCLUDED UNDER X RAY FROM (B)(6) 2025. TREATMENT WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Obstruction/Occlusion
MAUDE report 22730585 ↗InjuryAug 21, 2024Material Rupture; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Material Rupture; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation
IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN OSTIAL ANTERIOR TIBIAL (AT) LESION. ORBITAL ATHERECTOMY WAS PERFORMED TO PREPARE THE LESION. THE 3.75X18MM ESPRIT BTK SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. THE SYSTEM WAS INFLATED TO 12 ATMOSPHERES (ATM) WITHIN 7 SECONDS WHEN IT WAS NOTED THE BALLOON RUPTURED. THE INDEFLATOR WAS PRESSURIZED RAPIDLY IN AN ATTEMPT TO GET ANY ADDITIONAL LUMINAL GAIN. THE ESPRIT SYSTEM WAS REMOVED AND THE VIPERWIRE REMAINED IN PLACE. A 4.0X150MM NON-ABBOTT BALLOON DILATATION CATHETER WAS ADVANCED TO THE ESPRIT SCAFFOLD WHICH WAS LOCATED PROXIMALLY IN THE DISTAL POPLITEAL INTO THE OSTIAL AT. THE BALLOON WAS INFLATED QUICKLY TO 6ATM TO MAKE SURE IF ANYTHING WAS MOBILE, IT WOULD BE STABILIZED, THEN SLOWLY TO 12 ATM AND HELD FOR 1.5 MINUTES. THE BALLOON WAS REMOVED WITH NO DIFFICULTY. THE ESPRIT LOCATION WAS VERIFIED UNDER FLUORO. THE VIPERWIRE WAS REMOVED FROM THE AT AND REPOSITIONED IN THE TIBIO-PERONEAL TRUNK (TPT). A NAVICROSS 035 SUPPORT CATHETER WAS ADVANCED INTO THE TPT WITH NO RESISTANCE FELT; HOWEVER ON ANGIO IT WAS VISUALLY NOTED THE ESPRIT MARKER ¿FLEXED¿ DOWN TOWARDS THE TPT. THE CATHETER WAS PULLED BACK AND THEN READVANCED. N
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20015375 ↗
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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