Indigo System LITNGFXT100H1-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948029866), received between Nov 12, 2024 and Feb 9, 2026 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT AND RIGHT PULMONARY ARTERIES (PA) USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN ELEMENT VASCULAR ACCESS SHEATH (ELEMENT SHEATH), A NON-PENUMBRA PIGTAIL CATHETER AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT WAS INITIALLY ON 30 L OF OXYGEN AND WAS STEPPED DOWN TO 6 L SHORTLY BEFORE THE PROCEDURE. THE PATIENT WAS DESCRIBED AS GENERALLY VERY SICK. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE PULMONARY ARTERY USING A PIGTAIL CATHETER. A GUIDEWIRE WAS PLACED, AND THE ELEMENT SHEATH WAS ADVANCED INTO THE MAIN PULMONARY ARTERY WITHOUT INCIDENT. THE FLASH CATHETER WAS THEN INTRODUCED OVER THE GUIDEWIRE TO ACCESS THE LEFT PULMONARY ARTERY. AFTER REMOVING THE GUIDEWIRE, ASPIRATION WAS INITIATED, AND THE FLASH CATHETER WAS ADVANCED DISTALLY INTO THE LEFT LOWER LOBE. WHILE PREPARING TO PROCEED TO THE RIGHT PULMONARY ARTERY, THE CIRCULATING NURSE REPORTED THAT THE PATIENT WAS COUGHING UP BLOOD. AN ANGIOGRAM WAS PERFORMED, REVEALING A PERFORATION IN THE LEFT LUNG. THE PHYSICIAN ATTRIBUTED THE PERFORATION TO THE PATIENT'S DISEASED VESSELS AND GENERAL POOR HEALTH. CPR WAS PERFORMED, AND THE PHYSICIAN DE

  Patient problems: Perforation of Vessels

  MAUDE report 24288714 ↗
• MalfunctionJun 13, 2025Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC AND LEFT COMMON FEMORAL VEINS USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN ELEMENT VASCULAR ACCESS SHEATH (ELEMENT) AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT HAD BILATERAL ILIAC STENTS. DURING THE PROCEDURE, THE PHYSICIAN USED CONTRALATERAL ACCESS AND COMPLETED TWO PASSES USING THE ELEMENT SHEATH AND THE FLASH CATHETER. THE ELEMENT WAS NOT PROVIDING GOOD SUPPORT; THEREFORE, THE PHYSICIAN EXCHANGED THE ELEMENT WITH A NON-PENUMBRA SHEATH AND COMPLETED ONE PASS. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE FLASH CATHETER THROUGH THE SHEATH AND NOTICED UNDER FLUOROSCOPY THAT THE SHEATH AND THE FLASH CATHETER WERE KINKED. WHILE ATTEMPTING TO RETRACT THE FLASH CATHETER, THE FLASH CATHETER FRACTURED AT THE MID SHAFT. THE PHYSICIAN REMOVED THE FRACTURED PART OF THE FLASH CATHETER BY INFLATING A BALLOON IN THE SHEATH. IT WAS REPORTED THAT THERE WAS A STEEP BIFURCATION IN THE ILIAC STENTS, WHICH MADE FOR AN ACUTE ANGLE TO NAVIGATE. THE ANGLE MAY HAVE CAUSED THE NON-PENUMBRA SHEATH TO KINK. THE PROCEDURE WAS ABORTED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT HAD A VAGAL R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205758 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL, FEMORAL AND ILIAC VEINS USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), BALLOON CATHETERS, A STENT, GUIDEWIRES, AND A SHEATH. DURING THE PROCEDURE, THE FLASH CATHETER WAS ADVANCED INTO THE TARGET LOCATION AND SEVERAL PASSES WERE MADE. AN ANGIOGRAM WAS TAKEN AND AN EXTRAVASATION WAS NOTED AT THE ILIOCAVAL JUNCTION/RETROPERITONEAL AREA. A BALLOON CATHETER WAS INFLATED IN THE EXTRAVASATION AREA FOR FIVE MINUTES AND THE ISSUE RESOLVED. THE PHYSICIAN THEN CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME FLASH CATHETER. IT WAS REPORTED THAT THE PATIENT REMAINED STABLE DURING THE PROCEDURE AND POST-PROCEDURE. RETROPERITONEAL BLEED WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE. ON 11-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2025, THE PATIENT RETURNED WITH SWELLING AND PAIN AND WAS FOUND TO HAVE EXTENSIVE ACUTE CLOT IN THE MAJORITY OF THE LEFT LEG. RE-THROMBOSIS OF TARGET VESSEL WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO T

  Patient problems: Retroperitoneal Hemorrhage; Thrombosis/Thrombus

  MAUDE report 22179313 ↗
• MalfunctionNov 12, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE APPROXIMATELY FIVE TO SIX PASSES IN THE TARGET LOCATION USING THE FLASH CATHETER. IT WAS REPORTED THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ADVANCING THE FLASH CATHETER THROUGH A PREVIOUSLY PLACED STENT THAT HAD COLLAPSED. AFTER SUCCESSFULLY ASPIRATING IN THE VESSEL, THE PHYSICIAN REMOVED THE FLASH CATHETER AND NOTICED THE DISTAL END OF THE FLASH CATHETER WAS DAMAGED. THE PROCEDURE HAD ENDED AT THIS POINT AND NO ADDITIONAL DEVICE WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669580 ↗