EspritRecalls & reported problems across all models

We found 16 models of Esprit by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 163 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2024 and Sep 22, 2026 — classified as 2 deaths, 71 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Esprit problems

Esprit models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Esprit™ 1203300-38

  Scaffold, Infrapopliteal, Absorbable
  1 death47 reports
• Esprit™ 1203250-38

  Scaffold, Infrapopliteal, Absorbable
  37 reports
• Esprit™ 1203350-38

  Scaffold, Infrapopliteal, Absorbable
  1 death30 reports
• Esprit™ 1203375-38

  Scaffold, Infrapopliteal, Absorbable
  16 reports
• Esprit™ 1203300-28

  Scaffold, Infrapopliteal, Absorbable
  10 reports
• Esprit™

  Scaffold, infrapopliteal, absorbable
  4 reports
• Esprit™

  Scaffold, infrapopliteal, absorbable
  3 reports
• Esprit™ 1203350-18

  Scaffold, Infrapopliteal, Absorbable
  3 reports
• Esprit™ 1203250-28

  Scaffold, Infrapopliteal, Absorbable
  3 reports
• Esprit™

  Scaffold, infrapopliteal, absorbable
  2 reports
• Esprit™ 1203350-28

  Scaffold, Infrapopliteal, Absorbable
  2 reports
• Esprit™ 1203375-18

  Scaffold, Infrapopliteal, Absorbable
  2 reports
• Esprit™

  Scaffold, infrapopliteal, absorbable
  1 report
• Esprit™ 1203300-18

  Scaffold, Infrapopliteal, Absorbable
  1 report
• Esprit™ 1203375-28

  Scaffold, Infrapopliteal, Absorbable
  1 report
• Esprit™ 1203250-18

  Scaffold, Infrapopliteal, Absorbable
  1 report

Recent Esprit adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861221 ↗
• 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 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the procedure was performed to treat a de novo lesion in the tibioperoneal trunk (TPT) with 80% stenosis and heavy calcification, and popliteal and also a small area in the superficial femoral artery (SFA). Two (2) 3.0x38mm Esprit BTK stent were implanted to treat the TPT and intravascular lithotripsy (IVL) 3.0x 80 was used to treat the popliteal and the superficial femoral artery (SFA). A few hours later, the patient lost pulse. Re-angiography was performed and the popliteal and TPT scaffolds were clotted off. A non-Abbott thrombectomy balloon system was used to get the popliteal and scaffold open. Additionally, medication (tissue plasminogen activator) was administered. A dissection in the popliteal was observed which was treated with a non-Abbott covered stent. In the physician's opinion, the 2 Esprit BTK stents did not cause or contribute to the dissection. Post-dilatation was performed with a non-Abbott 3.0x120mm balloon. Result was decent. No additional information was provided.

  Patient problems: Diminished Pulse Pressure; Thrombosis/Thrombus

  MAUDE report 50847073 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the procedure was performed to treat a de novo lesion in the tibioperoneal trunk (TPT) with 80% stenosis and heavy calcification; and popliteal and also a small area in the superficial femoral artery (SFA). Two (2) 3.0x38mm Esprit BTK stent were implanted to treat the TPT and intravascular lithotripsy (IVL) 3.0x 80 was used to treat the popliteal and the superficial femoral artery (SFA). A few hours later, the patient lost pulse. Re-angiography was performed and the popliteal and TPT scaffolds were clotted off. A non-Abbott thrombectomy balloon system was used to get the popliteal and scaffold open. Additionally, medication (tissue plasminogen activator) was administered. A dissection in the popliteal was observed which was treated with a non-Abbott covered stent. In the physician's opinion, the 2 Esprit BTK stents did not cause or contribute to the dissection. Post-dilatation was performed with a non-Abbott 3.0x120mm balloon. Result was decent. No additional information was provided.

  Patient problems: Diminished Pulse Pressure; Thrombosis/Thrombus

  MAUDE report 50847026 ↗
• 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 16, 2026Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794570 ↗
• 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 ↗
• InjurySep 14, 2026Difficult to Remove; Difficult to Advance; Material Deformation; Material Twisted/Bent

  It was reported that the procedure was to treat a lesion in an unspecified artery. The 3.5x38mm Esprit BTK would not advance onto the 0.014" Command ES guidewire. The device did not enter sheath and would not go further. Scaffold and balloon were noted to be bunched up and deformed. Then the Esprit could not be removed from the guidewire either. The guidewire was cut just before the balloon tip to proceed. The same guidewire with another Esprit was used with no issue to complete the procedure. There was no adverse patient effect 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 50758254 ↗
• MalfunctionSep 14, 2026Stretched; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757235 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Stenosis

  MAUDE report 50741749 ↗
• MalfunctionSep 10, 2026Nonstandard Device; Deformation Due to Compressive Stress; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721559 ↗
• 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 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 ↗
• 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 ↗

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