Esprit™ 1203300-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 08717648357015), received between Oct 8, 2024 and Sep 22, 2026 — classified as 1 death, 17 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (11 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Difficult or Delayed Positioning; Difficult to Remove; Stretched; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857016 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient ID: (b)(6).It was reported the initial procedure was to treat the proximal right anterior tibial (AT) artery on (b)(6) 2025. A 3.0x38mm Esprit BTK scaffold was implanted without issue. On (b)(6) 2026, the patient returned with acute limb ischemia and pain in both legs however the left leg pain was more severe. Bilateral angiography showed left superficial femoral artery (SFA) chronic total occlusion (CTO) with 70% popliteal stenosis and occluded tibial vessels. The angiography showed 90% SFA, popliteal, and proximal AT stenosis with in-stent restenosis noted within the Esprit scaffold. Attempted intervention of the left SFA was unsuccessful as the balloon catheter was unable to cross the lesion. No right leg intervention was performed. No additional information was provided.

  Patient problems: Ischemia; Pain; Stenosis

  MAUDE report 50853996 ↗
• InjurySep 17, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress

  It was reported that that the procedure was to treat a 95% stenosed de novo lesion in the tibioperineal trunk (TPT). The 3x38mm Esprit BTK RX Scaffold System device was to be advanced, but resistance was felt with the bifurcation when the device came out of the sheath. The shaft became kinked and the Esprit device could no longer be advanced or retracted despite multiple attempts. The physician pulled hard on the Esprit device, and the distal portion of the Esprit device became separated. Therefore, a snared was used to remove the separated portion and the remainder of the device was pulled out, ending the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797485 ↗
• MalfunctionSep 15, 2026Break; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778265 ↗
• MalfunctionSep 14, 2026Stretched; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757235 ↗
• MalfunctionAug 31, 2026Deformation Due to Compressive Stress; Activation Failure

  It was reported that the procedure was to treat a lesion in the left anterior tibial artery. The 3x38mm Esprit BTK scaffold was advanced to the target lesion; however, the shaft kinked during a deployment attempt. Therefore, the device was removed from the patient. Another 3x38mm Esprit device was used to continue the procedure. There was no adverse patient effect and no clinically significant delay reported in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525616 ↗
• InjuryAug 26, 2026Break; Difficult to Advance

  It was reported the initial procedure on (b)(6) 2026 was to treat a lesion in the anterior tibial artery (ATA). Four Esprit BTK scaffolds (2.50x38 and three 3.0x38mm) were implanted. Optical Frequency Domain Imaging (OFDI) performed immediately after implantation confirmed good apposition of the scaffolds. The patient had relatively high ADL despite Chronic Limb-Threatening Ischemia (CLTI) and reportedly massaged the lower leg because of pain and frequently walked to improve blood flow. The patient returned to the hospital on (b)(6) 2026 and although the great toe wound was healing and showed almost no deterioration, angiography revealed occlusion beginning around the middle of the four implanted Esprit scaffolds. Passage of the guidewire was difficult; however, after crossing the lesion, OFDI demonstrated disruption of the 3.0x38mm Esprit structure and a fracture. A portion of the guidewire was observed outside the Esprit. Although images were not immediately available, the central portion appeared substantially disrupted. The findings were similar to coronary bioresorbable stent thrombosis associated with loss of scaffold support during the resorption process, resulting in protru

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 50454617 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient ID: (b)(6).It was reported the initial procedure was performed on (b)(6) 2025 to treat a heavily calcified lesion in the proximal right anterior tibial artery (ATA). The 3.0 x 38mm Esprit BTK scaffold was implanted without issue. The patient returned on (b)(6) 2026 with a recurrent wound ulcer on the right foot and a lower limb angiogram revealed chronic total occlusion of the right proximal to mid ATA, posterior tibial artery and of the right peroneal artery. Atherectomy and angioplasty were performed on (b)(6) 2026 as treatment. No additional information was provided.

  Patient problems: Impaired Healing; Obstruction/Occlusion

  MAUDE report 50325868 ↗
• MalfunctionJul 29, 2026Difficult to Insert; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077227 ↗
• MalfunctionJul 6, 2026Material Separation

  IT WAS REPORTED THAT THE ESPRIT BTK SHAFT BROKE INTO TWO PIECES DURING SCAFFOLD PREPARATION UPON REMOVAL OF THE YELLOW SHEATH. THE PROCEDURE WAS NOT CONTINUED AND THE VESSEL WAS NOT TREATED. THERE WAS NO PATIENT INVOLVEMENT 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 25724798 ↗
• InjuryJun 22, 2026Difficult or Delayed Positioning; Difficult to Advance; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL ARTERY WITH MILD CALCIFICATION AND 70% STENOSIS. THE 3.0X38 MM ESPRIT BTK SYSTEM WAS BEING DELIVERED WITHOUT AN UP AND OVER SHEATH BECAUSE THE PATIENT HAD A BYPASS GRAFT. WHERE THE BYPASS ANASTOMOSIS WAS LOCATED, THERE WERE CLIPS AND IT WAS THOUGHT THESE WERE THE BALLOON MARKERS. THE SCAFFOLD WAS DEPLOYED BUT THE IMAGE NEVER SHOWED THE BALLOON EXPAND. THIS IS BECAUSE THE ESPRIT WAS DEPLOYED IN THE GRAFT AS THE WIRE AND BALLOON SHAFT MIGRATED INTO THE AORTA BECAUSE THERE WAS NOT ENOUGH SUPPORT. THE SCAFFOLD WAS DEPLOYED INTO THE 7 MM GRAFT, AND THIS IS ASSUMED BECAUSE THE STENT COULD NOT BE SEEN FLOATING IN THE GRAFT. THE PATIENT WILL RETURN FOR FOLLOW UP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25585430 ↗
• MalfunctionJun 22, 2026Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0X38MM ESPRIT BTK SYSTEM, WHEN REMOVING THE PROTECTIVE SHEATH, THE DEVICE WAS COMPROMISED. DURING THE ATTEMPT TO INSERT THE GUIDE WIRE IT WAS THE TIP WAS KINKED. THE HYPOTUBE SHAFT SEPARATED. 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 25578579 ↗
• MalfunctionJun 15, 2026Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED LOWER EXTREMITY ARTERY. THE 3X38MM ESPRIT BTK SCAFFOLD FAILED TO DEPLOY. ANOTHER ESPRIT SCAFFOLD WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511841 ↗
• InjuryJun 9, 2026Difficult to Remove; Material Separation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED TIBIOPERONEAL TRUNK THAT IS 100% STENOSED. PRE DILATATION WAS PERFORMED AND THE 3.00 X 38 MM ESPRIT BTK BIORESORBABLE VASCULAR SCAFFOLD DELIVERY SYSTEM (SDS) WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE AND THROUGH THE SHEATH. IT APPEARED THAT THE SDS WAS ADVANCING SEPARATELY FROM THE WIRE, AND RESISTANCE NOTED DURING ADVANCEMENT AS THE SDS WAS NO LONGER OVER GUIDE WIRE. AN ATTEMPT WAS MADE TO WITHDRAW THE SDS; HOWEVER, THE BALLOON/SCAFFOLD APPEARED TO BUCKLE AND FOLD DURING REMOVAL; THEREFORE, THE SDS AND SHEATH WERE ATTEMPTED TO BE TOGETHER, BUT THE BALLOON AND SCAFFOLD SEPARATED NEAR THE ACCESS SITE. THE SEPARATED PORTION REMAINED IN RIGHT COMMON FEMORAL ARTERY AND WAS COVERED WITH A NON-ABBOTT STENT. A NEW ESPRIT WAS DEPLOYED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25447493 ↗
• MalfunctionMay 29, 2026Break; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH NO CALCIFICATION. THE 3.0X38 MM ESPRIT BTK DEVICE FAILED TO CROSS THE LESION. ANOTHER ESPRIT BTK ALSO FAILED AS WELL AS AN UNSPECIFIED CORONARY STENT. IT IS NOT KNOWN THE REASON OF THE NO CROSS. THERE WERE NO ADVERSE PATIENT EFFECTS. PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE SKIVE WAS SEPARATED DISTAL TO THE OUTER MEMBER TO HYPOTUBE SEAL AND A TEAR WAS NOTED ON THE OUTER MEMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337495 ↗
• MalfunctionMay 28, 2026Inflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE DURING PREPARATION, THE 3X38MM ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEM WAS INADVERTENTLY FLUSHED THROUGH THE INFLATION PORT. DESPITE THIS, THE CONNECTION WAS SECURE ENOUGH AND NEGATIVE AIR WAS PULLED TO ASPIRATE AIR. HOWEVER, THE BALLOON WAS INADVERTENTLY PARTIALLY INFLATED; THE DISTAL AND PROXIMAL MARGINS WERE FLARED. THEREFORE, THE SCAFFOLD WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320123 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, TWO 3.0X38 MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE PROXIMAL RIGHT POSTERIOR TIBIAL ARTERY. ON (B)(6) 2026, THE PATIENT HAD BILATERAL LOWER EXTREMITY INTERMITTENT CLAUDICATION, RIGHT WORSE THAN LEFT. BILATERAL ANGIOGRAPHY SHOWED BILATERAL OCCLUSION IN THE INDEX ARTERY AND NON-INDEX VESSELS. ENDOVASCULAR INTERVENTION USING DIRECTIONAL ATHERECTOMY OF THE RIGHT POSTERIOR TIBIAL ARTERY WAS PERFORMED. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 25233706 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  US 0418-583. IT WAS REPORTED THAT ON (B)(6) 2025, TWO 3.0X38 MM ESPRIT BTK SCAFFOLDS WERE IMPLANTED IN THE PROXIMAL RIGHT POSTERIOR TIBIAL ARTERY. ON (B)(6) 2026, THE PATIENT HAD BILATERAL LOWER EXTREMITY INTERMITTENT CLAUDICATION, RIGHT WORSE THAN LEFT. BILATERAL ANGIOGRAPHY SHOWED BILATERAL OCCLUSION IN THE INDEX ARTERY AND NON-INDEX VESSELS. ENDOVASCULAR INTERVENTION USING DIRECTIONAL ATHERECTOMY OF THE RIGHT POSTERIOR TIBIAL ARTERY WAS PERFORMED. THE CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 25233701 ↗
• MalfunctionMay 4, 2026Material Separation; Material Deformation

  IT WAS REPORTED THAT WHEN THE YELLOW PROTECTIVE SHEATH WAS REMOVED FROM THE 3.0X38 MM ESPRIT BTK DEVICE AND THE DISTAL STENT EDGE WAS NOTED TO BE DAMAGED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER ESPRIT BTK DEVICE WAS USED TO COMPLETE THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT A PORTION OF THE FIRST AND SECOND RING AT THE DISTAL END OF THE SCAFFOLD WAS SEPARATED AND NOT RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072917 ↗
• MalfunctionApr 24, 2026Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT WHILE ADVANCING THE 3.0X28 MM ESPRIT BTK RX SCAFFOLD DELIVERY SYSTEM INTO THE PATIENT, IT STOPPED ADVANCING ON THE WIRE OUTSIDE OF THE BODY. WHEN THEY TRIED TO PULL THE DELIVERY SYSTEM OFF THE WIRE, RESISTANCE WAS FELT, AND THE NOSE CONE (TIP OF THE DELIVERY SYSTEM) SEPARATED, BUT REMAINED ON THE WIRE. THEY WERE ABLE TO REMOVE THE NOSE CONE FROM THE WIRE AND WERE ABLE TO ADVANCE ANOTHER ESPRIT BTK DEVICE AND PLACE IT IN THE RIGHT ANTERIOR TIBIAL ARTERY. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984425 ↗
• MalfunctionMar 4, 2026Improper or Incorrect Procedure or Method; Ambient Temperature Problem

  IT WAS REPORTED THAT A 3X28 MM ESPRIT BTK STENT AND A 3X38 MM ESPRIT STENT WERE IMPLANTED; HOWEVER, POST-STENT IMPLANTATION THE TEMPERATURE SENSOR WAS NOTED TO DISPLAY AN X ON THE PACKAGING OF BOTH STENTS. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513984 ↗
• DeathMar 3, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRIMARY CAUSE OF DEATH IS LISTED AS CORONARY ARTERY DISEASE. THERE WERE NOT ANY NEW STENOSES IDENTIFIED PRIOR TO DEATH. IN THE PHYSICIAN'S OPINION, THE ESPRIT BTK DEVICE, DID NOT CAUSE A CARDIOVASCULAR DEATH OVER 8 MONTHS AFTER THE SCAFFOLD IMPLANTATION IN THE LOWER EXTREMITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Vascular Problem

  MAUDE report 24500309 ↗
• MalfunctionFeb 6, 2026Improper or Incorrect Procedure or Method; Ambient Temperature Problem

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT PERONEAL ARTERY THAT IS 80% STENOSED. AFTER THE 3.00X38MM ESPRIT BTK RESORBABLE SCAFFOLD WAS IMPLANTED, IT WAS REALIZED THAT THE TEMPERATURE SENSOR WITH THE TAG ALERT WAS NOT INSPECTED PRIOR TO IMPLANTATION AND WAS NOTED TO BE TRIGGERED. AS A RESULT, A XIENCE PRIME STENT WAS IMPLANTED TO RELINE THE SCAFFOLD. ANGIOGRAM REVEALED THE VESSEL TO BE OPEN AND PATENT. 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 24282932 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 3.0X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE RIGHT PROXIMAL POSTERIOR TIBIAL ARTERY. ON (B)(6) 2025, THE PATIENT HAD REDNESS AND PAIN DURING A FOLLOW UP VISIT. ANGIOGRAM WAS SCHEDULED FOR (B)(6) 2026. ON (B)(6) 2026 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR AN ANGIOGRAM, WHICH REVEALED RE-OCCLUSION OF RIGHT SUPERFICIAL FEMORAL ARTERY, POPLITEAL AND POSTERIOR TIBIAL ARTERIES. LOWER LIMB REVASCULARIZATION WAS PERFORMED ON (B)(6) 2026. RECANALIZATION WAS PERFORMED IN THE OCCLUDED SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, AND POSTERIOR TIBIAL ARTERY. BALLOON ANGIOPLASTY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Obstruction/Occlusion; Pain

  MAUDE report 24247878 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 24166067 ↗