Indigo System CAT8XTORQ115KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00815948020450), received between May 16, 2019 and Jul 16, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERIES USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), NON-PENUMBRA ADAPTER. IT WAS REPORTED THAT THE PATIENT HAD A PULMONARY EMBOLISM WITH SIGNIFICANT RIGHT VENTRICULAR STRAIN. DURING THE PROCEDURE, WHILE ASPIRATING IN THE RIGHT PULMONARY ARTERY USING THE CAT8, THE PHYSICIAN NOTICED THAT THE CAT8 WAS ASPIRATING A LOT OF AIR WITH MINIMAL BLOOD. THE SYSTEM WAS THEN CHECKED FOR AIR LEAKS. THE ADAPTER WAS TIGHTENED, THE LID ON THE CANISTER WAS TIGHTENED, AND THE CANISTER WAS PROPERLY SEATED ON THE ENGINE. THE PLACEMENT OF THE CAT8 WAS NOT OCCLUSIVE, AND BLOOD WAS VISUALIZED TO BE LEAKING OUT FROM THE JUNCTION BETWEEN THE HUB OF THE CAT8 AND THE CAT8 ITSELF. SUBSEQUENTLY, A TEGADERM WAS PLACED OVER THE AREA OF THE LEAK, AND THE PHYSICIAN CONTINUED ASPIRATION USING THE CAT8 UNTIL A STAFF MEMBER CAME INTO THE ROOM WITH ANOTHER CAT8. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286467 ↗
• MalfunctionJul 1, 2020Material 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 MADE MULTIPLE PASSES USING THE CAT8. WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT8 THROUGH THE SHEATH. CONSEQUENTLY, THE CAT8 BECAME KINKED TOWARDS THE PROXIMAL END NEAR THE HUB. THEREFORE, THE CAT8 WAS REMOVED. 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 Consequences Or Impact To Patient

  MAUDE report 10217914 ↗
• MalfunctionJun 11, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH IN THE RIGHT GROIN. NEXT, WHILE ADVANCING THE CAT8 OVER A GUIDEWIRE WITH AN ADDITIONAL GUIDEWIRE ALONG THE SIDE OF THE CAT8, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE DISTAL PORTION OF THE CAT8, APPROXIMATELY 20 CENTIMETERS FROM THE TIP BECAME KINKED. THEREFORE, THE CAT8 AND SHEATH WERE REMOVED. IT WAS REPORTED THAT THE OVERALL DIAMETER OF THE CAT8 AND THE ADDITIONAL GUIDEWIRE NEXT TO THE CAT8 WAS TOO LARGE FOR THE ROTATING HEMOSTASIS VALVE (RHV) WHICH CAUSED ADDITIONAL FORCE TO ADVANCE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8, SHEATH AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141664 ↗
• MalfunctionMay 14, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES USING THE CAT8 WITH LITTLE ASPIRATION. UPON REMOVAL, THE PHYSICIAN NOTICED A KINK NEAR THE DISTAL END OF THE CAT8. A NEW CAT8 WAS THEN INSERTED AND SEVERAL PASSES WERE MADE; HOWEVER, UPON REMOVAL, THE PHYSICIAN NOTICED THE CAT8 TO BE KINKED NEAR THE DISTAL END. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING BOTH CAT8S INTO THE SHEATH. THE PHYSICIAN THEN DECIDED TO CHANGE THE SHEATH AND REALIZED THAT IT WAS SEVERELY KINKED DUE TO THE ANTEGRADE ACCESS AND PATIENT¿S ANATOMY. THE PROCEDURE WAS THEN ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060108 ↗
• MalfunctionMay 14, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES USING THE CAT8 WITH LITTLE ASPIRATION. UPON REMOVAL, THE PHYSICIAN NOTICED A KINK NEAR THE DISTAL END OF THE CAT8. A NEW CAT8 WAS THEN INSERTED AND SEVERAL PASSES WERE MADE; HOWEVER, UPON REMOVAL, THE PHYSICIAN NOTICED THE CAT8 TO BE KINKED NEAR THE DISTAL END. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING BOTH CAT8S INTO THE SHEATH. THE PHYSICIAN THEN DECIDED TO CHANGE THE SHEATH AND REALIZED THAT IT WAS SEVERELY KINKED DUE TO THE ANTEGRADE ACCESS AND PATIENT¿S ANATOMY. THE PROCEDURE WAS THEN ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060105 ↗
• MalfunctionMar 18, 2020Decrease in Suction; Material Deformation; Decrease in Suction; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), NON-PENUMBRA SHEATH AND, NON-PENUMBRA GLIDE CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO REMOVE A LARGE VOLUME OF THE CLOT USING A STANDARD CORING TECHNIQUE FOLLOWING A TISSUE PLASMINOGEN ACTIVATOR (TPA) INFUSION WITH THE GLIDE CATHETER. NEXT, WHILE ADVANCING THE CAT8, THE PHYSICIAN NOTICED THAT TIP OF THE CAT8 STARTED TO SLIGHTLY BEND AND THE FLOW INTO THE CANISTER BECAME SLOW. THE PHYSICIAN CONTINUED TO USE THE SAME CAT8 TO COMPLETE FOUR PASSES AND COMPLETED THE PROCEDURE. AFTER THE PROCEDURE, UPON FURTHER INSPECTION OF THE CAT8 DISTAL TIP, THE PHYSICIAN NOTICED THAT THE DISTAL DEFLECTION TO BE SLIGHTLY KINKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850223 ↗
• MalfunctionNov 25, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES USING THE CAT8 WITH A PINNACLE SHEATH. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE CAT8. WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE PHYSICIAN WAS TORQUING THE CAT8 AND NOTICED THE MIDSHAFT BECAME KINKED; THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE PATIENT HAD SMALL VESSEL ACCESS AND A POSSIBLE SPASM CLAMPED DOWN ON THE CAT8. 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 Consequences Or Impact To Patient

  MAUDE report 9370682 ↗
• MalfunctionNov 11, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING AN INDIGO SYSTEM CAT 8 KIT. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) USING A PEEL AWAY SHEATH, THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND INTO A NON-PENUMBRA 8F SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE CAT8. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL TIP OF THE CAT8 KINKED. THE PROCEDURE WAS CONTINUED USING ANOTHER CAT8 AND THE SAME SHEATH. THE PHYSICIAN THEN DECIDED TO REMOVE THE CAT8 AND SHEATH TO STENT THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING A 11F SHEATH AND STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305694 ↗
• MalfunctionOct 16, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, AFTER MAKING FOUR PASSES USING THE CAT8 WITH AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND A NON-PENUMBRA SHEATH, THE PHYSICIAN REMOVED THE CAT8 AND THE HOSPITAL TECHNICIAN FOUND IT TO BE KINKED IN FOUR DIFFERENT PLACES AT THE DISTAL TIP. HOWEVER, THE PHYSICIAN CONTINUED TO USE THE SAME CAT8 AND SEP8 TO MAKE ANOTHER PASS AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200084 ↗
• MalfunctionSep 26, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 KIT. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) INTO THE FLOW VALVE OF AN 8F NON-PENUMBRA SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND, SUBSEQUENTLY, THE CAT8 KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND ANOTHER 8F SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124472 ↗
• MalfunctionMay 16, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PENUMBRA ENGINE (ENGINE) WAS UNABLE TO BUILD VACUUM WITH THE CANISTER AND, THEREFORE, THE PHYSICIAN SWITCHED TO A NEW CANISTER. THE PROCEDURE WAS THEN CONTINUED, AND THE PHYSICIAN USED A CAT8 TO ASPIRATE WITHIN THE PATIENT. AFTER MAKING A PASS, THE CAT8 WAS REMOVED AND FLUSHED ON THE BACK TABLE. HOWEVER, THE PROXIMAL END OF THE CAT8 WAS INADVERTENTLY KINKED WHILE BEING FLUSHED. THE PROCEDURE WAS THEN COMPLETED USING A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615427 ↗