Indigo System CAT8XTORQ115KIT-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00815948022485), received between May 20, 2020 and Apr 29, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO GUIDEWIRES THROUGH THE PIN HOLE VALVE OF THE SHEATH TO PROVIDE ADDITIONAL SUPPORT. THE CAT8 WAS THEN ADVANCE OVER THE TWO GUIDEWIRES; HOWEVER, THE CAT8 WOULD NOT ADVANCE PAST THE VALVE OF THE SHEATH. CONSEQUENTLY, WHEN ATTEMPTING TO FURTHER ADVANCE THE CAT8 PAST THE VALVE, THE DISTAL TIP OF THE CAT8 BECAME KINKED AND, THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO USE A BLADE TO PLACE TWO SMALL INCISIONS IN THE PIN HOLE VALVE OF THE SHEATH TO LOOSEN UP THE VALVE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 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 11745406 ↗
• InjuryMar 11, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMOROPOPLITEAL USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), NON-PENUMBRA 5FR DIAGNOSTIC CATHETER, AND NON-PENUMBRA SHEATH. IT WAS ALSO REPORTED THAT THE SHEATH WAS PREVIOUSLY BUCKLING INTO THE AORTA WHILE USING A DIAGNOSTIC CATHETER AND GUIDEWIRE TO CROSS THE LESION. DURING THE PROCEDURE, THE CAT8 WAS ADVANCED OVER THE GUIDEWIRE AND RETRACTED BACK ONCE WITH ASPIRATION. NEXT, THE PHYSICIAN ADVANCED THE CAT8 MORE DISTALLY AND THEN REMOVED THE GUIDEWIRE; SUBSEQUENTLY, THE PHYSICIAN WANTED TO RETRACT THE CAT8 WITHOUT THE GUIDEWIRE. HOWEVER, WHILE RETRACTING, THE MIDSHAFT OF THE CAT8 BECOME BROKEN INSIDE OF THE SHEATH AT THE BIFURCATION. THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN CAT8 USING A SNARE DEVICE AND A BALLOON CATHETER BUT WAS UNSUCCESSFUL. THEREFORE, THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE REMAINING BROKEN CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467544 ↗
• MalfunctionNov 25, 2020Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A 12F NON-PENUMBRA SHORT SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES USING THE CAT8 AND SHEATH. WHILE ADVANCING THE CAT8 DURING ANOTHER PASS THROUGH ONE OF THE ALREADY IMPLANTED STENTS, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE TIP OF THE CAT8 STRETCHED AND BROKE, BUT REMAINED ATTACHED TO THE REST OF THE CAT8. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10899714 ↗
• MalfunctionNov 13, 2020Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A PENUMBRA ENGINE (ENGINE), A GUIDEWIRE AND NON-PENUMBRA SHEATH. IT WAS NOTED THAT THERE WAS STENOSIS IN THE TARGET VESSEL. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 OVER THE GUIDEWIRE, THROUGH THE SHEATH AND INTO THE TARGET VESSEL TO PERFORM ASPIRATION. TOWARDS THE END OF THE PROCEDURE, AFTER COMPLETING THREE PASSES USING THE CAT8, THE PHYSICIAN NOTICED FULL ASPIRATION COULD NOT BE ACHIEVED WITH THE ENGINE. UPON EXAMINING THE CAT8, THE PHYSICIAN OBSERVED THAT THE PROXIMAL END OF THE CAT8 WAS TWISTED AND HAD A SMALL HOLE WHERE IT WAS BEING TORQUED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10839933 ↗
• MalfunctionOct 27, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT COMMON ILIAC ARTERY USING INDIGO SYSTEM ASPIRATION CATHETER 8S (CAT8S) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT8 INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE DISTAL END OF THE CAT8 KINKED. SUBSEQUENTLY, THE CAT8 WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING A SECOND CAT8 AND COMPLETED FIVE PASSES. WHILE ATTEMPTING TO MAKE THE NEXT PASS, THE PHYSICIAN NOTICED THE CAT8 WAS UNABLE TO ASPIRATE THE THROMBUS. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER AND THROMBOLYTIC THERAPY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10744552 ↗
• MalfunctionOct 3, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) USING INDIGO SYSTEM ASPIRATION CATHETER 8S (CAT8), A GUIDEWIRE AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 OVER THE GUIDEWIRE THROUGH THE SHEATH FROM THE RIGHT COMMON FEMORAL ARTERY ACCESS, UP AND OVER THE AORTIC ARCH INTO THE TARGET VESSEL. THE GUIDEWIRE WAS REMOVED AND ASPIRATION WAS TURNED ON. WHILE ASPIRATING THE CLOT IN THE LEFT SUPERFICIAL FEMORAL ARTERY, THE PHYSICIAN NOTICED THE FLOW OF BLOOD THROUGH THE TUBING WAS SLOW. THE PHYSICIAN THEN TORQUED THE CAT8 FOR OPTIMAL VESSEL SWEEP TO ASPIRATE THE CLOT AND A LARGE QUANTITY OF BLOOD FLOWED INTO THE CANISTER. NEXT, THE PHYSICIAN REMOVED THE CAT8 TO CHECK THE PROGRESS OF THE ASPIRATION. UPON REMOVING THE CAT8 OUT OF THE SHEATH, THE PHYSICIAN NOTICED THE CAT8 WAS BROKEN OFF AND ONLY ONE THIRD OF THE CAT8 WAS REMOVED. THE PHYSICIAN THEN REMOVED THE SHEATH, LEAVING THE CAT8 IN THE PATIENT¿S BODY. AFTER REMOVAL OF THE SHEATH, PART OF THE CAT8 WAS EXPOSED OUTSIDE OF THE PATIENT. THE PHYSICIAN THEN INTENTIONALLY CUT THE CAT8 TO ADVANCE A GUIDEWIRE THOUGH THE CAT8 SO THAT ACCESS TO THE VESSEL COULD BE M

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10624222 ↗
• MalfunctionAug 26, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIOPERONEAL TRUNK USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 THROUGH THE SHEATH AND WHILE TORQUING; THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PROXIMAL END OF THE CAT8 BECAME BROKEN AT THE VALVE OF THE SHEATH. IT WAS REPORTED THAT THE ROTATING HEMOSTASIS VALVE (RHV) WAS TIGHTENED DOWN TOO TIGHTLY. THEREFORE, THE PHYSICIAN REMOVED THE SHEATH WHILE RETRACTING THE CAT8 SIMULTANEOUSLY AND REMOVED BOTH DEVICES. THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454539 ↗
• MalfunctionJul 24, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) IN THE LEFT ILIAC ARTERY AND FEMORAL VEINS USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND, NON-PENUMBRA SHEATH (TERUMO). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE SEP8 AND CAT8. WHILE ADVANCING THE SEP8 FOR ANOTHER PASS, THE PHYSICIAN NOTICED AFTER SOME TIME THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 BROKE OFF IN THE LEFT ILIOFEMORAL VEIN. THE CAT8 AND SEP8 WERE THEREFORE REMOVED. IT WAS REPORTED THAT THE CAT8 WAS FOUND TO BE KINKED NEAR THE DISTAL TIP. THE PHYSICIAN THEN ADVANCED A NEW CAT8 TO ASPIRATE AND REMOVE THE BROKEN WIRE OF THE SEP8. IT WAS ALSO REPORTED THAT THE BROKEN PIECE OF THE SEP8 WAS OBSERVED ON THE BACK TABLE AND FLUOROSCOPY CONFIRMED THAT THE ENTIRE BROKEN WIRE PIECE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN DECIDED THAT THE THROMBECTOMY PORTION OF THE PROCEDURE WAS SUFFICIENT AND COMPLETED THE PROCEDURE USING BALLOON ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321142 ↗
• MalfunctionMay 20, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATHS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SHEATH IN THE TARGET VESSEL. WHILE ADVANCING THE CAT8 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE CAT8 BECAME STUCK; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN THEN PLACED A SECOND SHEATH IN THE VESSEL AND ADVANCED THE SAME CAT8 THROUGH THE SECOND SHEATH, AND THE SAME ISSUE OCCURRED; THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER CAT8, THE AFOREMENTIONED FIRST SHEATH, AND ADMINISTERING TISSUE PLASMINOGEN ACTIVATOR (TPA) DRIP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10077371 ↗