Esprit™ 1203250-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 08717648357251), received between Jun 26, 2024 and Sep 16, 2026 — classified as 19 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (9 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794570 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Stenosis

  MAUDE report 50741749 ↗
• MalfunctionJul 16, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25848381 ↗
• MalfunctionJul 14, 2026Material Separation; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816954 ↗
• MalfunctionJul 8, 2026Break; Failure to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753128 ↗
• MalfunctionJul 8, 2026Difficult to Remove; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753045 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4) IT WAS REPORTED THAT ON (B)(6) 2025, ONE 2.5X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT TIBIOPERONEAL TRUNK. ON (B)(6) 2026 ARTERIAL DUPLEX SHOWED OCCLUSION IN THE LEFT ANTERIOR AND POSTERIOR TIBIAL ARTERIES. TREATMENT WAS DEFERRED PENDING ORTHOPEDIC TREATMENT FOR THE KNEE AND HIP. ON (B)(6) 2026 LASER ATHERECTOMY AND ANGIOPLASTY WERE PERFORMED IN THE LEFT TIBIOPERONEAL TRUNK AND PERONEAL ARTERY. ANGIOPLASTY WAS ALSO PERFORMED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25322966 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THREE OVERLAPPED, ESPRIT BTK SCAFFOLDS (2.5X38 MM) WERE IMPLANTED ON (B)(6) 2025 IN THE LEFT ANTERIOR TIBIAL ARTERY (ATA). ON (B)(6) 2026, THE PATIENT PRESENTED WITH LIFESTYLE-LIMITING CLAUDICATION SYMPTOMS. THE PATIENT WAS FOUND TO HAVE RESTENOSIS (OCCLUSION) IN THE ESPRIT BTK SCAFFOLDS OF THE L ATA (INDEX LIMB), WHICH REQUIRED ATHERECTOMY AND PLACEMENT OF A XIENCE SKYPOINT STENT. ATHERECTOMY WAS ALSO PERFORMED IN THE POSTERIOR TIBIAL ARTERY (PTA) TO TREAT THE CHRONIC TOTAL OCCLUSION OF THE PTA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 25186318 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THREE OVERLAPPED, ESPRIT BTK SCAFFOLDS (2.5X38 MM) WERE IMPLANTED ON (B)(6) 2025 IN THE LEFT ANTERIOR TIBIAL ARTERY (ATA). ON (B)(6) 2026, THE PATIENT PRESENTED WITH LIFESTYLE-LIMITING CLAUDICATION SYMPTOMS. THE PATIENT WAS FOUND TO HAVE RESTENOSIS (OCCLUSION) IN THE ESPRIT BTK SCAFFOLDS OF THE L ATA (INDEX LIMB), WHICH REQUIRED ATHERECTOMY AND PLACEMENT OF A XIENCE SKYPOINT STENT. ATHERECTOMY WAS ALSO PERFORMED IN THE POSTERIOR TIBIAL ARTERY (PTA) TO TREAT THE CHRONIC TOTAL OCCLUSION OF THE PTA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 25186309 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THREE OVERLAPPED, ESPRIT BTK SCAFFOLDS (2.5X38 MM) WERE IMPLANTED ON (B)(6) 2025 IN THE LEFT ANTERIOR TIBIAL ARTERY (ATA). ON (B)(6) 2026, THE PATIENT PRESENTED WITH LIFESTYLE-LIMITING CLAUDICATION SYMPTOMS. THE PATIENT WAS FOUND TO HAVE RESTENOSIS (OCCLUSION) IN THE ESPRIT BTK SCAFFOLDS OF THE L ATA (INDEX LIMB), WHICH REQUIRED ATHERECTOMY AND PLACEMENT OF A XIENCE SKYPOINT STENT. ATHERECTOMY WAS ALSO PERFORMED IN THE POSTERIOR TIBIAL ARTERY (PTA) TO TREAT THE CHRONIC TOTAL OCCLUSION OF THE PTA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 25186306 ↗
• MalfunctionMay 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS NOTED THAT THE SCAFFOLD OF A 2.5X38 MM ESPRIT BTK SYSTEM CAME LOOSE FROM THE BALLOON AFTER REMOVING THE PROTECTIVE SHEATH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084859 ↗
• InjuryApr 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2026 TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR TIBIAL ARTERY (AT). THE 2.50 X 38MM ESPRIT BTK SCAFFOLD WAS IMPLANTED WITHOUT ISSUE. THE PATIENT RETURNED ON (B)(6) 2026 AND AN ADDITIONAL PROCEDURE WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814912 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, THE 2.5X38 MM ESPRIT BTK WAS IMPLANTED IN THE LEFT TIBIOPERONEAL TRUNK AND THE 2.5X38 MM ESPRIT BTK WAS IMPLANTED IN THE LEFT POSTERIOR TIBIAL ARTERY. ON (B)(6) 2026, THE PATIENT HAD DRY GANGRENE OF THE 4TH DIGIT ON THE LEFT FOOT. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WHERE A HEPARIN DRIP WAS ADMINISTERED. THE PATIENT UNDERWENT AN ANGIOGRAM FOR PAIN/ISCHEMIC SYMPTOMS. THERE WAS OCCLUSION IN BOTH ESPRIT BTKS. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2026 WITH BALLOON ANGIOPLASTY, LASER ATHERECTOMY, AND THROMBOLYSIS. ON (B)(6) 2026, THROMBOLYSIS WAS AGAIN PERFORMED. ON (B)(6) 2026, BALLOON ANGIOPLASTY AND STENTING WERE PERFORMED. MULTIPLE ATTEMPTS WERE REQUIRED TO RESTORE PERFUSION TO THE EXTREMITY AFTER INITIAL ATTEMPTS WERE UNSUCCESSFUL. BELOW THE KNEE AMPUTATION OF THE TARGET LIMB WAS PERFORMED ON (B)(6) 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Pain; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 24698144 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, THE 2.5X38 MM ESPRIT BTK WAS IMPLANTED IN THE LEFT TIBIOPERONEAL TRUNK AND THE 2.5X38 MM ESPRIT BTK WAS IMPLANTED IN THE LEFT POSTERIOR TIBIAL ARTERY. ON 0(B)(6) 2026, THE PATIENT HAD DRY GANGRENE OF THE 4TH DIGIT ON THE LEFT FOOT. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WHERE A HEPARIN DRIP WAS ADMINISTERED. THE PATIENT UNDERWENT AN ANGIOGRAM FOR PAIN/ISCHEMIC SYMPTOMS. THERE WAS OCCLUSION IN BOTH ESPRIT BTKS. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2026 WITH BALLOON ANGIOPLASTY, LASER ATHERECTOMY, AND THROMBOLYSIS. ON (B)(6) 2026, THROMBOLYSIS WAS AGAIN PERFORMED. ON (B)(6) 2026, BALLOON ANGIOPLASTY AND STENTING WERE PERFORMED. MULTIPLE ATTEMPTS WERE REQUIRED TO RESTORE PERFUSION TO THE EXTREMITY AFTER INITIAL ATTEMPTS WERE UNSUCCESSFUL. BELOW THE KNEE AMPUTATION OF THE TARGET LIMB WAS PERFORMED ON (B)(6) 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Pain; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 24698141 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, THE 2.5X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT PROXIMAL ANTERIOR TIBIAL ARTERY (ATA). ON (B)(6) 2026, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FROM THE CARDIOLOGIST'S OFFICE VISIT WITH FOOT PAIN, REPORTEDLY MANAGED WITH MEDICATION. IT WAS NOTED THAT THE LEFT FOOT WAS NOT AS RED OR SWOLLEN. REVASCULARIZATION WAS PERFORMED WITH BALLOON ANGIOPLASTY IN THE LEFT, SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, ANTERIOR TIBIAL ARTERY, INCLUDING THE STUDY SCAFFOLD/TARGET VESSEL. THE 100% STENOSIS WAS SUCCESSFULLY REDUCED TO 10% STENOSIS. THIS PATIENT HAS HAD A PREVIOUS OCCLUSION FILED UNDER MFR REPORT # 2024168-2026-00417. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 24297492 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, THE 2.5X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT PROXIMAL ANTERIOR TIBIAL ARTERY (ATA). THE DOPPLER ULTRASOUND THAT WAS PERFORMED ON (B)(6) 2025 SHOWED THE LOWER EXTREMITY ARTERIAL SCAFFOLD APPEARS TO BE OCCLUDED WITH NO EVIDENCE OF A DOPPLER SIGNAL. ON (B)(6) 2025, THE PATIENT WAS FOUND TO HAVE A RE-OCCLUSION OF THE LEFT ATA. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE LEFT ATA WAS PERFORMED ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24214420 ↗
• MalfunctionJan 28, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH CALCIFICATION AND A DISSECTION PRESENT. THE 3.5X38 MM ESPRIT BTK DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS THE LESION POTENTIALLY DUE TO A PRE-EXISTING DISSECTION FLAP BUT THE REASON IS UNKNOWN. IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS PARTIALLY COMING OFF OF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED AND A 3.0X38 MM ESPRIT BTK DELIVERY SYSTEM WAS THEN ATTEMPTED BUT THIS DEVICE ALSO DID NOT CROSS, POTENTIALLY DUE TO THE DISSECTION FLAP. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203072 ↗
• MalfunctionDec 23, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT PERONEAL ARTERY. THE 2.50X38MM RX ESPRIT BTK SYSTEM MET RESISTANCE WHILE ADVANCING AND DURING REMOVAL DUE TO THE ANATOMY AND THE GUIDE WIRE EXIT NOTCH WAS NOTED TO BE KINKED. A 2.50X38MM OTW ESPRIT BTK SYSTEM WAS ADVANCED AND MET RESISTANCE DUE TO THE ANATOMY THEREFORE IT WAS REMOVED. THE LESION WAS DILATED WITH A BALLOON CATHETER AND THE SAME 2.50X38MM OTW ESPRIT BTK WAS REINTRODUCED INTO THE VESSEL WITHOUT ISSUE AND THE SCAFFOLD IMPLANTED. 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 23878551 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025 ONE 2.5X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT POSTERIOR TIBIAL ARTERY. ON (B)(6) 2025 THE PATIENT HAD A PERSISTENT WOUND AND WORSENING ANKLE BRACHIAL INDEX AT THE FOLLOW UP VISIT. A LOWER LIMB ANGIOGRAM FOUND RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY, POSTERIOR TIBIAL ARTERY AND ANTERIOR TIBIAL ARTERY. ANGIOPLASTY WAS PERFORMED IN THE RESTENOSIS. THE CONDITION RESOLVED WITHOUT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 23682231 ↗
• MalfunctionNov 20, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THAT THE DEVICES BECAME STUCK AND COULD NOT BE ADVANCED OR REMOVED FROM EACH OTHER PRIOR TO THE ESPRIT BEING ADVANCED INTO THE ANATOMY. FORCE WAS USED DURING REMOVAL OF THE DEVICES FROM EACH OTHER WITHOUT REMOVING THE WIRE OUT OF THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612147 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY. THE 2.50X38MM ESPRIT BTK RESORBABLE SCAFFOLD WAS IMPLANTED. IT WAS NOTED THAT DURING SCAFFOLD IMPLANTATION, POST-DILATION WAS NOT PERFORMED. ON (B)(6) 2025, THE PATIENT PRESENTED WITH PAIN IN THE LOWER LEFT LEG AND ANGIOGRAM REVEALED SCAFFOLD THROMBOSIS; HOWEVER, NO TREATMENT WAS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 23305135 ↗
• MalfunctionJul 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT PERONEAL ARTERY WITH MILD CALCIFICATION AND 99% STENOSIS. THE 2.5X38 MM ESPRIT BELOW THE KNEE (BTK) BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED IN THE DISTAL PERONEAL AND A 3.0X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED MORE PROXIMALLY. IT WAS NOTED THAT THE 2.5X38 MM ESPRIT SCAFFOLD WAS EXPIRED. THE PHYSICIAN WAS AWARE BUT DEPLOYED THE DEVICE. 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 22577718 ↗
• InjuryJul 14, 2025Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT LESIONS IN THE ANTERIOR TIBIAL (AT) AND TIBIOPERONEAL TRUNK (TPT). THE 3.0X38MM ESPRIT BTK SCAFFOLD AND TWO 2.50X38MM ESPRIT BTK SCAFFOLDS WERE DEPLOYED IN THE TARGET LESIONS HOWEVER IMMEDIATELY AFTER DEPLOYMENT THE SCAFFOLDS BROKE. A SNARE DEVICE WAS USED TO REMOVE THE BROKEN SCAFFOLDS FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER ESPRIT SCAFFOLD. 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 22494456 ↗
• InjuryJul 14, 2025Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT LESIONS IN THE ANTERIOR TIBIAL (AT) AND TIBIOPERONEAL TRUNK (TPT). THE 3.0X38MM ESPRIT BTK SCAFFOLD AND TWO 2.50X38MM ESPRIT BTK SCAFFOLDS WERE DEPLOYED IN THE TARGET LESIONS HOWEVER IMMEDIATELY AFTER DEPLOYMENT THE SCAFFOLDS BROKE. A SNARE DEVICE WAS USED TO REMOVE THE BROKEN SCAFFOLDS FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER ESPRIT SCAFFOLD. 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 22494452 ↗
• MalfunctionJun 10, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POSTERIOR TIBIAL ARTERY. THE 2.5X38MM ESPRIT BELOW THE KNEE (BTK) WAS NOT PREPPED AND NOTED TO FEEL RESISTANCE WHEN REMOVING THE PROTECTIVE SHEATH. THE 300 NON-ABBOTT GUIDE WIRE WAS ALREADY IN PLACE WHEN THE ESPRIT WAS ATTEMPTED TO BE ADVANCE; HOWEVER, BEFORE IT COULD ADVANCE IN THE ANATOMY THE DEVICE BECAME STUCK WITH THE GUIDE WIRE. THE DEVICE COULD NOT BE REMOVED INDEPENDENTLY; THEREFORE, THE GUIDE WIRE AND ESPRIT WERE REMOVED TOGETHER. THE CASE WAS ABORTED AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179875 ↗