Esprit™ (REF 1212300-38)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648354021), received between Apr 21, 2026 and Sep 21, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025 THREE ESPRIT OTW SCAFFOLDS (SIZES 2.5X38, 3.0X38 (X2) MM) WERE IMPLANTED IN THE PROXIMAL RIGHT ANTERIOR TIBIAL ARTERY. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2026, THE PATIENT HAD BILATERAL CYANOSIS AND NON-PALPABLE PULSES. THE PATIENT WAS SCHEDULED FOR AN ANGIOGRAM TO TREAT A LOWER LIMB ARTERIAL OCCLUSION (STENOSIS) IN ALL THREE INDEX SCAFFOLDS. ON (B)(6) 2026, HE UNDERWENT SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE TARGET ANTERIOR TIBIAL ARTERY, WHICH IMPROVED FROM 100% STENOSIS TO RESTORED PATENCY AND FLOW. THE PROCEDURE RESTORED PERFUSION WITHOUT COMPLICATION, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24944477 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025 THREE ESPRIT OTW SCAFFOLDS (SIZES 2.5X38, 3.0X38 (X2) MM) WERE IMPLANTED IN THE PROXIMAL RIGHT ANTERIOR TIBIAL ARTERY. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2026, THE PATIENT HAD BILATERAL CYANOSIS AND NON-PALPABLE PULSES. THE PATIENT WAS SCHEDULED FOR AN ANGIOGRAM TO TREAT A LOWER LIMB ARTERIAL OCCLUSION (STENOSIS) IN ALL THREE INDEX SCAFFOLDS. ON (B)(6) 2026, HE UNDERWENT SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE TARGET ANTERIOR TIBIAL ARTERY, WHICH IMPROVED FROM 100% STENOSIS TO RESTORED PATENCY AND FLOW. THE PROCEDURE RESTORED PERFUSION WITHOUT COMPLICATION, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24944455 ↗