Esprit™ 1203375-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648357176), received between Feb 3, 2025 and Jun 30, 2026 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4) IT WAS REPORTED THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO TREAT A MODERATELY CALCIFIED PROXIMAL LEFT TIBIOPERONEAL TRUNK ARTERY. A 3.75X38MM ESPRIT BTK SCAFFOLD WAS IMPLANTED WITHOUT ISSUE. ON (B)(6) 2026 IT WAS NOTED THE ESPRIT SCAFFOLD HAD OCCLUDED. THE PATIENT WAS BEING SCHEDULED FOR INDEX LESION REVASCULARIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Diminished Pulse Pressure; Impaired Healing; Obstruction/Occlusion

  MAUDE report 25667253 ↗
• InjuryMay 19, 2026Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TIBIAL ARTERY. DURING ADVANCEMENT OF THE 3.75X38MM ESPRIT BTK RESORBABLE SCAFFOLD DELIVERY SYSTEM (SDS) OVER A 0.014 NON-ABBOTT GUIDE WIRE, DIFFICULTY WAS NOTED DUE TO ANATOMY. THE SDS WAS REMOVED AND REINSERTED INTO THE PATIENT WHEN THE SCAFFOLD DISLODGED INSIDE THE PATIENT PRIOR TO DEPLOYMENT. A PORTION OF THE SCAFFOLD WAS SIMPLY WITHDRAWN, AND THE REMAINING PORTION OF THE SCAFFOLD WAS STENTED AGAINST THE TARGET LESION WITH A NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25223007 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 TWO 3.75X38MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE LEFT ANTERIOR TIBIAL ARTERY OVERLAPPING 1 MM. ON (B)(6) 2026 THE PATIENT RETURNED TO THE HOSPITAL WITH LEFT LEG PAIN AND CLAUDICATION. THEREFORE, ANGIOGRAPHY WAS PERFORMED AND A PSEUDOANEURYSM WAS NOTED WHERE THE TWO STENTS OVERLAPPED. IT WAS NOTED THAT BOTH STENTS REMAINED PATENT. AN UNSPECIFIED COVERED STENT WAS IMPLANTED TO TREAT THE PSEUDO ANEURYSM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Pseudoaneurysm

  MAUDE report 24880372 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 TWO 3.75X38MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE LEFT ANTERIOR TIBIAL ARTERY OVERLAPPING 1 MM. ON (B)(6) 2026 THE PATIENT RETURNED TO THE HOSPITAL WITH LEFT LEG PAIN AND CLAUDICATION. THEREFORE, ANGIOGRAPHY WAS PERFORMED AND A PSEUDOANEURYSM WAS NOTED WHERE THE TWO STENTS OVERLAPPED. IT WAS NOTED THAT BOTH STENTS REMAINED PATENT. AN UNSPECIFIED COVERED STENT WAS IMPLANTED TO TREAT THE PSEUDO ANEURYSM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Pseudoaneurysm

  MAUDE report 24880349 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, TWO 3.75X38 MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE LEFT LOWER LIMB: ONE IN THE TIBIO-PERONEAL TRUNK TO THE POSTERIOR TIBIAL ARTERY AND THE SECOND IN THE PERONEAL ARTERY. TWO NON-TARGET LESIONS ON THE LEFT LOWER LIMB WERE ALSO TREATED AT THE INDEX STUDY PROCEDURE. TWO DAYS POST PROCEDURE, ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WITH WORSENING FOOT PAIN IN THE INDEX LIMB. IT WAS DETERMINED THAT THE LIMB PAIN IS LIKELY SECONDARY TO ACUTE REPERFUSION FROM ARTERIALIZATION OF THE POSTERIOR TIBIAL VEIN. THE PATIENT WAS TREATED WITH A HEPARIN INTRAVENOUS DRIP. THE CONDITION RESOLVED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE CLINIC FOR A FOLLOW-UP VISIT. THE PATIENT WAS ADMITTED FOR SCANS AND OBSERVATIONS. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN FOUND AN OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY AND NO FLOW IN THE CALF ARTERIES. THE FOOT WAS NOT SALVAGEABLE. AMPUTATION WAS PERFORMED ABOVE THE LEFT KNEE ON (B)(6) 2025. THE PATIENT WAS DISCHARGED FROM THE AMPUTATION ADMISSION ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS FOUND UNRESPONSIVE AT HIS ASSISTED LIVING FACILITY. THE PATIENT'S PULSE WAS A

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 24006010 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, TWO 3.75X38 MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE LEFT LOWER LIMB: ONE IN THE TIBIO-PERONEAL TRUNK TO THE POSTERIOR TIBIAL ARTERY AND THE SECOND IN THE PERONEAL ARTERY. TWO NON-TARGET LESIONS ON THE LEFT LOWER LIMB WERE ALSO TREATED AT THE INDEX STUDY PROCEDURE. TWO DAYS POST PROCEDURE, ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WITH WORSENING FOOT PAIN IN THE INDEX LIMB. IT WAS DETERMINED THAT THE LIMB PAIN IS LIKELY SECONDARY TO ACUTE REPERFUSION FROM ARTERIALIZATION OF THE POSTERIOR TIBIAL VEIN. THE PATIENT WAS TREATED WITH A HEPARIN INTRAVENOUS DRIP. THE CONDITION RESOLVED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS SEEN IN THE CLINIC FOR A FOLLOW-UP VISIT. THE PATIENT WAS ADMITTED FOR SCANS AND OBSERVATIONS. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN FOUND AN OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY AND NO FLOW IN THE CALF ARTERIES. THE FOOT WAS NOT SALVAGEABLE. AMPUTATION WAS PERFORMED ABOVE THE LEFT KNEE ON (B)(6) 2025. THE PATIENT WAS DISCHARGED FROM THE AMPUTATION ADMISSION ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS FOUND UNRESPONSIVE AT HIS ASSISTED LIVING FACILITY. THE PATIENT'S PULSE WAS A

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 24006008 ↗
• MalfunctionNov 7, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL ANTERIOR TIBIAL ARTERY WITH HEAVY TORTUOSITY AND NARROW STENOSIS THE 3.75X38 MM ESPRIT BELOW THE KNEE (BTK) SCAFFOLD SYSTEM BECAME STUCK ON A PIECE OF CALCIUM DURING ADVANCEMENT. WHEN THE DEVICE WAS INFLATED TO NOMINAL PRESSURE, THE BALLOON WAS NOTED TO BE RUPTURED. THE BALLOON AND DELIVERY SYSTEM WERE REMOVED AND THE STENT STAYED IN PLACE. POST DILATATION WAS PERFORMED PER STANDARD PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501439 ↗
• MalfunctionSep 24, 2025Peeled/Delaminated; Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Peeled/Delaminated; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. FOLLOWING PRE-DILATATION, A 3.0X38MM, 3.75X38MM, AND 3.75X38MM ESPRIT BTK SCAFFOLD DEVICES WERE ATTEMPTED TO BE ADVANCED TO THE LESION; HOWEVER, ALL THE DEVICES WERE NOTED TO FAIL TO CROSS THE LESION, WITH SUBSEQUENT KINKS ALONG THE DELIVERY SYSTEM BEING NOTED. AT THIS POINT A FOURTH UNSPECIFIED ESPRIT BTK DEVICE WAS USED AND WAS SUCCESSFULLY ABLE TO CROSS THE LESION BE IMPLANTED; HOWEVER, FOLLOWING ITS REMOVAL, KINKS ON THE DELIVERY SYSTEM WERE NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. THE 3.75 X 38MM ESPRIT BTK DEVICE RETURN ANALYSIS REVEALED THAT THERE WAS BALLOON MATERIAL SHREDDING NOTED ALONG THE BALLOON, AND A PORTION OF THE DISTAL END OF THE SCAFFOLD WAS SEPARATED AND NOT RETURNED. THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RETURNED AND NOTED THAT THEY WERE UNAWARE OF THE SEPARATION OF THE SCAFFOLD AND SHREDDING OF THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137232 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE SCAFFOLD WAS FOUND OCCLUDED VIA THE DUPLEX ULTRASOUND ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22959112 ↗
• MalfunctionAug 28, 2025Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILDLY CALCIFIED TIBIOPERINEAL ARTERY. AFTER PRE-DILATION, A 3.75X38MM ESPRIT BTK DRUG-ELUTING RESORBABLE SCAFFOLD SYSTEM WAS IMPLANTED. AFTER IMPLANTATION, POST-DILATION WAS PERFORMED AND UPON REMOVAL, THE SCAFFOLD GOT STUCK TO THE TIP OF THE INTERVENTIONAL WIRE AND THE ESPRIT SCAFFOLD WAS EXPLANTED. AN UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. 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 22916593 ↗
• 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 22730572 ↗
• MalfunctionJul 1, 2025Break; Leak/Splash; Failure to Advance; Material Deformation; Material Split, Cut or Torn; Break; Leak/Splash; Failure to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE LESION WAS PRE-DILATED WITH A 3.5 MM BALLOON. THE 3.75X38 MM ESPRIT BELOW THE KNEE (BTK) DELIVERY SYSTEM FAILED TO CROSS THE LESION AND A SMALLER ESPRIT BTK DEVICE WAS ABLE TO CROSS. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS FLUID LEAKING FROM A HOLE IN THE OUTER MEMBER, A TEAR IN THE GUIDE WIRE EXIT NOTCH AND A BROKEN STRUT. THE ACCOUNT STATED THE STENT WAS NOTED TO BE CRIMPED UPON REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375278 ↗
• MalfunctionJun 9, 2025Stretched; Difficult to Advance; Stretched; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO USE THE 3.75X38MM ESPRIT BTK SYSTEM HAD DIFFICULTY ADVANCING OVER THE 0.014 COMMAND ES GUIDE WIRE AND THROUGH THE GUIDE WIRE EXIT PORT, RESULTING IN THE SHAFT STRETCHING. THE SHAFT WAS THEN CUT WITH A BLADE IN ORDER TO REMOVE THE ESPRIT FROM THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED USING THE SAME GUIDE WIRE AND A NEW DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167374 ↗
• InjuryMay 29, 2025Inflation Problem; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Patient-Device Incompatibility; Difficult to Advance; Inflation Problem; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Patient-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE PERENNIAL ARTERY. THE 3.0X38MM ESPRIT BTK SYSTEM WAS NOT FLUSHED PROPERLY AND WHEN THE SYSTEM WAS ATTEMPTED TO BE ADVANCED OVER THE GUIDE WIRE, IT BECAME STUCK. THE SYSTEM WAS REMOVED AND NOT USED. A 3.75X38MM ESPRIT BTK SYSTEM WAS NOT PREPPED (AIR ASPIRATION) PRIOR TO USE AND ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED TO 9 ATMOSPHERES (ATM). THERE WAS CALCIUM IN THE VESSEL OF THE DISTAL AREA OF THE SCAFFOLD, AND DUE TO THE BUBBLE IN THE BALLOON, NOT ENOUGH CONTRAST WAS PUSHED THROUGH TO FULLY EXPAND THE DISTAL PART OF THE SCAFFOLD. THE DELIVERY SYSTEM WAS REMOVED AND AN ATTEMPT WAS MADE TO ADVANCE A BALLOON CATHETER TO POST DILATE THE SCAFFOLD BUT IT WOULD NOT CROSS THE SCAFFOLD. FLOW OF THE VESSEL APPEARED TO BE BLOCKED AT THE DISTAL END WHERE THE AIR BUBBLE APPEARED TO BE. MULTIPLE GUIDE WIRES AND BALLOONS WERE USED TO CROSS THE SCAFFOLD TO FULLY EXPAND THE SCAFFOLD AND RESTORE FLOW. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22104232 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE ON (B)(6) 2024 WAS TO TREAT A LESION IN THE RIGHT PROXIMAL PERONEAL ARTERY. THE LESION WAS TREATED WITH AN AURYON LASER AND 4.0 SHOCKWAVE TO LESS THAN 30% RESIDUAL STENOSIS. THE 3.75X38MM ESPRIT BTK SCAFFOLD WAS IMPLANTED WITHOUT ISSUE. THE PATIENT RETURNED AT A FOLLOW UP VISIT COMPLAINING OF FOOT PAIN. OCCLUSION WAS NOTED PROXIMAL TO THE SCAFFOLD, EXTENDING THROUGH THE SCAFFOLD TO APPROXIMATELY 30 MM DISTAL OF THE SCAFFOLD. RIGHT LOWER EXTREMITY REVASCULARIZATION WAS PERFORMED AS TREATMENT ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 21293803 ↗
• MalfunctionFeb 3, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POSTERIOR TIBIAL WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 3.75X38MM ESPRIT BTK SYSTEM WAS PREPARED ACCORDING TO THE INSTRUCTION FOR USE (IFU); HOWEVER, WHEN REMOVING THE SHEATH THERE WAS RESISTANCE. WHEN AN ATTEMPT WAS MADE TO ADVANCE THE SYSTEM OVER THE COMMAND GUIDE WIRE THERE WAS RESISTANCE AND THE ESPRIT BECAME STUCK. THE ESPRIT WAS NEVER INSERTED INTO THE PATIENT ANATOMY; HOWEVER THE GUIDE WIRE HAD TO BE REMOVED FROM THE PATIENT WITH THE ESPRIT ON THE PROXIMAL END OF THE WIRE. A NON-ABBOTT GUIDE WIRE AND A NEW ESPRIT WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293706 ↗