Esprit™ 1203300-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648356995), received between Dec 10, 2024 and Jun 5, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE TIBIAL PERONEAL TRUNK (TPT). THERE WAS A LESION PRESENT IN THE TPT. THE LESION WAS PRE-DILATED WITH A 3.0 NON-ABBOTT BALLOON AND A DISSECTION WITHIN THE TPT WAS NOTED. THE 3.0X28MM ESPRIT BTK DELIVERY SYSTEM WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) WITHOUT ISSUES AND ADVANCED WITHOUT RESISTANCE. DURING ATTEMPTED ESPRIT DEPLOYMENT, THE DEVICE WAS NOT HOLDING PRESSURE, AND THE INDEFLATOR WAS PULLED BACK. BLOOD WAS SEEN INSIDE OF THE INFLATION DEVICE SUGGESTING A RUPTURE OF THE ESPRIT DELIVERY BALLOON. THE DELIVERY SYSTEM WAS REMOVED WITH THE STENT STILL CRIMPED ON THE BALLOON BUT WAS EXPANDED WHEN OUTSIDE THE ANATOMY FOR TROUBLESHOOTING. A NON-ABBOTT BALLOON WAS USED 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 25412245 ↗
• MalfunctionMar 4, 2026Improper or Incorrect Procedure or Method; Ambient Temperature Problem

  IT WAS REPORTED THAT A 3X28MM ESPRIT BTK STENT AND A 3X38MM 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 24508439 ↗
• MalfunctionFeb 20, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. THE 3.0X28MM ESPRIT BTK SCAFFOLD WAS IMPLANTED HOWEVER THE SCAFFOLD DID NOT APPEAR TO BE SUFFICIENTLY APPOSED TO THE VESSEL WALL POST DEPLOYMENT. NO ADDITIONAL TREATMENT WAS PERFORMED. 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 24401272 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 THE 3X28 ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE PROXIMAL TO MID ANTERIOR TIBIAL ARTERY WITHOUT ISSUE. DURING ROUTINE FOLLOW-UP ON (B)(6) 2026, NO PALPABLE TOE PULSE WAS NOTED; THEREFORE, THE PATIENT RETURNED ON (B)(6) 2026 FOR IMAGING AND IN-STENT RESTENOSIS WAS NOTED. INTRAVASCULAR LITHOTRIPSY (IVL) AND BALLOONING WAS PERFORMED, FOLLOWED BY IMPLANTATION OF ANOTHER ESPRIT BTK SCAFFOLD TO TREAT THE RESTENOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE.

  Patient problems: Diminished Pulse Pressure; Obstruction/Occlusion

  MAUDE report 24317704 ↗
• MalfunctionNov 26, 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, MILDLY TORTUOUS PERONEAL ARTERY THAT IS 80-90% STENOSED. TWO NON-ABBOTT GUIDE WIRES WERE ADVANCED, ONE IN THE POSTERIOR TIBIAL AND OTHER IN THE PERONEAL ARTERY. A 3.0X28MM ESPRIT BELOW THE KNEE (BTK) STENT DELIVERY SYSTEM WAS ATTEMPTED TO ADVANCE TO THE PERONEAL ARTERY; HOWEVER, FAILED AS THE DELIVERY SYSTEM MET RESISTANCE WITH GUIDE WIRE IN THE POSTERIOR TIBIAL ARTERY. DURING REMOVAL OF THE ESPRIT BTK DELIVERY SYSTEM RESISTANCE WAS MET WITH THE GUIDE WIRE AND THE SHAFT OF THE ESPRIT BTK WAS NOTED TO ACCORDION. 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 23662772 ↗
• MalfunctionNov 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE 3.0X28MM ESPRIT BTK SYSTEM WAS INSPECTED PRIOR TO USE AND IT WAS NOTED THE DEVICE EXPIRED ON 6/06/2025. THE PHYSICIAN ACKNOWLEDGED THE EXPIRATION HOWEVER DECIDED TO IMPLANT THE SCAFFOLD ANYWAY. THE DEVICE WAS USED WITHOUT ISSUE. 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 23531502 ↗
• MalfunctionApr 22, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, PRIOR TO USE, THE 3.0X28MM ESPRIT BTK SYSTEM COULD ONLY ADVANCE ABOUT 2-3 INCHES OVER THE 0.014 COMMAND GUIDE WIRE. THE DEVICE WAS REMOVED AND NOT USED IN THE PATIENT. A NEW NON-ABBOTT DEVICE WAS USED TO CONTINUE THE PROCEDURE WITH THE SAME COMMAND GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED A HOLE IN THE INNER MEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880839 ↗
• MalfunctionApr 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. THE 3.0X28MM ESPRIT BTK SYSTEM WAS ATTEMPTED TO BE USED HOWEVER PRIOR TO ENTERING THE PATIENT, THE SCAFFOLD WAS NOTED TO BE FLARED. ANOTHER ESPRIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE FIRST RING AT THE DISTAL END OF THE SCAFFOLD WAS FLARED AND BROKEN BUT STILL INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864747 ↗
• InjuryMar 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY. THE LESION WAS PREPARED USING A DIAMONDBACK ATHERECTOMY DEVICE AND BALLOON DILATATION. THE 3.0X28MM ESPRIT BTK SYSTEM WAS ADVANCED AND PLACED AT THE TARGET LESION. THE BALLOON WAS INFLATED TO 10 ATMOSPHERES (ATM) AND HELD FOR 30 SECONDS. THE SCAFFOLD WAS THEN POST DILATATED WITH A 3.0X15 NON-COMPLAINT BALLOON CATHETER. ANGIOGRAM REVEALED THE DISTAL END OF THE SCAFFOLD WAS STILL CRIMPED. AN ATTEMPT WAS MADE TO ADVANCE A BALLOON CATHETER THROUGH THE SCAFFOLD HOWEVER IT WOULD NOT CROSS. PEDAL ACCESS WAS GAINED AND BALLOON CATHETER WAS SUCCESSFUL IN CROSSING THE SCAFFOLD AND INFLATED TO EXPAND THE DISTAL END. 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 21606165 ↗
• InjuryDec 10, 2024Migration; Migration

  SUBSEQUENT TO THE INITIALLY FILED REPORT, IT SHOULD BE NOTED THAT IT IS ESPRIT BELOW THE KNEE (BTK). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898313 ↗