Indigo System LITNGFXT100H1-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948024823), received between May 12, 2023 and Apr 5, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A PENUMBRA ENGINE (ENGINE) AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT HAD A DISTINCT ANATOMY WITH A DUPLICATED POPLITEAL VEIN. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ACCESS ONE OF THE DUPLICATED POPLITEAL VEINS WITH THE CAT12; HOWEVER, THE ACCESS WAS NOT SUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO RE-ACCESS THE LARGER POPLITEAL VEIN WITH THE FLASH CATHETER. AFTER ACCESS WAS GAINED WITH THE FLASH CATHETER, IT WAS NOTICED THAT THE FLASH TUBING WAS ILLUMINATING FLASHING RED LIGHT. THEREFORE, THE FLASH CATHETER AND THE FLASH TUBING WERE REMOVED. THE PHYSICIAN COMPLETED ONE PASS USING A NEW FLASH CATHETER OVER THE GUIDEWIRE. THE GUIDEWIRE WAS THEN REMOVED, AND THE PHYSICIAN DECIDED TO DO ONE MORE PASS WITHOUT THE GUIDEWIRE. WHEN THE FLASH CATHETER WAS ADVANCED FOR A SECOND PASS, A PERFORATION WAS NOTED FROM THE FEMORAL VEIN AT THE MID THIGH LEVEL. A FINAL VENOGRAM REVEALED THE PERFORATION HAD RESOLVED ON

  Patient problems: Perforation of Vessels

  MAUDE report 19055737 ↗
• MalfunctionMay 12, 2023Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BILATERAL ILIAC ARTERIES USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER, A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FLASH CATHETER OVER THE GUIDEWIRE INTO THE STENTS. AFTER COMPLETING THREE PASSES USING THE FLASH CATHETER, THE FLASH CATHETER KEPT GETTING STUCK ON THE STENT FRAME. THEREFORE, THE FLASH CATHETER WAS REMOVED. UPON REMOVAL, THE PHYSICIAN INSPECTED THE FLASH CATHETER AND NOTICED THAT THE DISTAL END OF THE FLASH CATHETER WAS OVALIZED AND FRACTURED BUT IT WAS INTACT. THE PROCEDURE WAS COMPLETED USING A NEW FLASH CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925107 ↗