Indigo System LITNGBT6XTX-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810169721186), received between Aug 25, 2025 and Mar 4, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6X (CAT6X), A TRAX DELIVERY DEVICE (TRAX), AND A NON-PENUMBRA SHEATH (6F). DURING THE PROCEDURE, WHILE ADVANCING THE CAT6X WITH THE TRAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE CAT6X AT THE DISTAL END. WHILE REMOVING THE CAT6X WITH THE TRAX, THE CAT6X BECAME STRETCHED. THE PHYSICIAN CONTINUED TO RETRACT THE CAT6X AND THE CAT6X FRACTURED AT THE DISTAL END. THE PROXIMAL END OF THE CAT6X AND THE TRAX WERE REMOVED. A VASCULAR SURGEON PERFORMED A SURGICAL CUTDOWN IN THE POPLITEAL ARTERY TO REMOVE THE REMAINING SEGMENT OF THE CAT6X. NO PORTION OF THE CAT6X REMAINED IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH OPEN THROMBECTOMY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512097 ↗
• InjurySep 5, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT FEMORAL POPLITEAL VEIN GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 6X (CAT6X), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AND A NON-PENUMBRA SHEATH (6F). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET LOCATION USING THE CAT6X. WHILE ADVANCING THE CAT6X TO THE DISTAL PORTION OF THE VEIN GRAFT FOR A SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT6X BECAME STUCK. THE SHEATH HAD PROLAPSED INTO THE AORTA AND THE DISTAL END OF THE CAT6X FRACTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED PORTION OF THE CAT6X USING A LOOP SNARE DEVICE (7MM), BUT THE ATTEMPT WAS UNSUCCESSFUL. THE FRACTURED PORTION OF THE CAT6X WAS LEFT IN THE FEMORAL ARTERY TO THE POPLITEAL ARTERY VEIN GRAFT IN THE LEFT LEG. AN INFUSION CATHETER WAS PLACED IN THE VESSEL TO ADMINISTER TISSUE PLASMINOGEN ACTIVATOR (TPA) OVERNIGHT WITH NO CHANGES TO THE BASELINE STATUS. THE FOLLOWING DAY, THE PHYSICIAN PERFORMED ANOTHER ENDOVASCULAR PROCEDURE TO REMOVE THE FRACTURED DISTAL END OF THE CAT6X USING A SNARE DEVICE, BUT THE ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN PERFORMED AN OPEN SURGERY AND WAS ABLE

  Patient problems: Foreign Body In Patient

  MAUDE report 22976879 ↗
• MalfunctionAug 25, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AN INDIGO SYSTEM ASPIRATION CATHETER 6X (CAT6X) AND AN INDIGO SYSTEM SEPARATOR 4 (SEP4). IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUSLY IMPLANTED STENT IN THE POPLITEAL ARTERY AND THE THROMBUS WAS LOCATED DISTAL TO THE STENT. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE CAT6X THEN PERFORMED AN ANGIOGRAM. THE ANGIOGRAM REVEALED ADDITIONAL THROMBUS FARTHER DOWN THE TIBIAL ARTERY. THE PHYSICIAN ATTEMPTED TO COMPLETE ADDITIONAL PASSES WITH THE CAT6X, HOWEVER, NO THROMBUS WAS INGESTED. WHILE RETRACTING THE CAT6X, THE PHYSICIAN MET RESISTANCE AND THE CAT6X BECAME STUCK. AFTER USING SIGNIFICANT FORCE, THE CAT6X WAS RETRACTED AND REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED A SECOND ANGIOGRAM AND DECIDED TO SWITCH TO AN OPEN EMBOLECTOMY. DURING THE OPEN EMBOLECTOMY, THE PHYSICIAN FOUND A FRACTURED SEGMENT OF THE CAT6X WITHIN THE VESSEL. THEREFORE, THE SEGMENT OF CAT6X WAS REMOVED FROM THE PATIENT WITH A BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH THE SAME BALLOON CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884547 ↗