Indigo CATDRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00814548017624), received between Apr 19, 2017 and Sep 24, 2019 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (14 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN VEIN USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATD THROUGH A NON-PENUMBRA SHEATH AND OVER A GUIDEWIRE. WHILE ADVANCING THE CATD THROUGH A TORTUOUS TIGHT AREA OF THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE DISTAL END OF THE CATD KINKED; THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD AND THE SAME SHEATH AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112125 ↗
• MalfunctionJun 26, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION OF A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WAS FLATTENED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED CATD WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATD.

  Patient problems: No Patient Involvement

  MAUDE report 8736403 ↗
• MalfunctionMay 29, 2019Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VENA CAVA USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). DURING THE PROCEDURE, THE CATD WAS INADVERTENTLY BENT WHILE BEING ADVANCED INTO A NON-PENUMBRA SHEATH. THEREFORE, THE CATD WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW CATD 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 8649626 ↗
• MalfunctionFeb 22, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS COMPRESSED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATD.

  Patient problems: No Patient Involvement

  MAUDE report 8364455 ↗
• MalfunctionFeb 12, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD.

  Patient problems: No Patient Involvement

  MAUDE report 8332473 ↗
• MalfunctionNov 17, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD). DURING THE PROCEDURE, WHILE INSERTING A CATD INTO AN 8F NON-PENUMBRA SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, IT WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE TIP OF THE CATD WAS PINCHED. THEREFORE, THE PHYSICIAN REMOVED THE SHEATH AND THE PROCEDURE WAS COMPLETED USING A NEW CATD AND A NEW SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8082204 ↗
• MalfunctionSep 28, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF THE INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WAS KINKED UPON OPENING THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE, THEREFORE, THE CATD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATD.

  Patient problems: No Patient Involvement

  MAUDE report 7919943 ↗
• MalfunctionSep 5, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). DURING THE PROCEDURE, THE TIP OF THE CATD BECAME FLATTENED AS THE TECHNICIAN ATTEMPTED TO ADVANCE IT INTO A NON-PENUMBRA SHEATH. THE CATD WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW CATHETER 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 7847635 ↗
• MalfunctionJul 20, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). DURING THE PROCEDURE, THE PHYSICIAN MADE THREE PASSES USING THE CATD WITH A NON-PENUMBRA SHEATH. UPON REMOVING THE CATD TO FLUSH IT, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE CATD WAS KINKED. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW CATD 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 7708149 ↗
• MalfunctionJul 11, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN FOUND THAT THE INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE. THEREFORE, THE CATD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8).

  Patient problems: No Patient Involvement

  MAUDE report 7680127 ↗
• InjuryJul 3, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO DE-CLOT A LOOP GRAFT USING INDIGO SYSTEM CATD ASPIRATION CATHETERS (CATDS). DURING THE PROCEDURE, THE TIP OF A CATD BECAME KINKED WHILE BEING ADVANCED THROUGH A NON-PENUMBRA SHEATH AND, THEREFORE, THE CATD WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW CATD, HOWEVER, THE TIP OF THE NEW CATD BECAME KINKED AS WELL, AND THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN NOTICED THAT THE LOOP GRAFT HAD TORN AND, THEREFORE, THE PHYSICIAN IMPLANTED STENTS TO TREAT THE TEAR. THE PATIENT WAS THEN SENT TO THE OPERATING ROOM TO REMOVE THE ARTERIAL PLUG AND COMPLETE THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 7660248 ↗
• InjuryJul 3, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO DE-CLOT A LOOP GRAFT USING INDIGO SYSTEM CATD ASPIRATION CATHETERS (CATDS). DURING THE PROCEDURE, THE TIP OF A CATD BECAME KINKED WHILE BEING ADVANCED THROUGH A NON-PENUMBRA SHEATH AND, THEREFORE, THE CATD WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW CATD, HOWEVER, THE TIP OF THE NEW CATD BECAME KINKED AS WELL, AND THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN NOTICED THAT THE LOOP GRAFT HAD TORN AND, THEREFORE, THE PHYSICIAN IMPLANTED STENTS TO TREAT THE TEAR. THE PATIENT WAS THEN SENT TO THE OPERATING ROOM TO REMOVE THE ARTERIAL PLUG AND COMPLETE THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 7660245 ↗
• MalfunctionMay 22, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE INDIGO SYSTEM SEPARATOR D (SEPD) AND THE INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WERE DROPPED ON THE FLOOR WHILE THE SEPD WAS LOADED INSIDE THE CATD. THE REPORTED ISSUE WAS FOUND PRIOR TO USE AND THEREFORE, THE SEPD AND THE CATD WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7535042 ↗
• MalfunctionMay 16, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS KINKED, FLATTENED, AND CRUSHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD OCCURRED PRIOR TO USE. THEREFORE, THE CATD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATD.

  Patient problems: No Patient Involvement

  MAUDE report 7520176 ↗
• MalfunctionMay 9, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN FOUND THAT THE INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE AND THEREFORE, THE CATD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATD.

  Patient problems: No Patient Involvement

  MAUDE report 7498789 ↗
• MalfunctionApr 19, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE NEAR THE BRACHIAL ARTERY USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). DURING THE PROCEDURE, THE PHYSICIAN MADE ABOUT 10 PASSES USING THE CATD WITH A NON-PENUMBRA SHEATH. THE PHYSICIAN THEN FELT RESISTANCE WHILE MAKING ANOTHER PASS, AND THE CATD BECAME KINKED. THE CATD WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 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 7444274 ↗
• MalfunctionMar 20, 2018Collapse; Device Damaged Prior to Use; Out-Of-Box Failure; Collapse; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIPS OF TWO INDIGO SYSTEM CATD ASPIRATION CATHETERS (CATDS) WERE CRUSHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGES TO THE CATDS WERE FOUND PRIOR TO USE. THEREFORE, THE CATDS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE COMPLETED USING A THROMBECTOMY DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7355975 ↗
• MalfunctionMar 20, 2018Collapse; Device Damaged Prior to Use; Out-Of-Box Failure; Collapse; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIPS OF TWO INDIGO SYSTEM CATD ASPIRATION CATHETERS (CATDS) WERE CRUSHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGES TO THE CATDS WERE FOUND PRIOR TO USE. THEREFORE, THE CATDS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE COMPLETED USING A THROMBECTOMY DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7355972 ↗
• MalfunctionMar 12, 2018Collapse; Device Damaged Prior to Use; Out-Of-Box Failure; Collapse; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL TECHNICIAN FOUND THAT THE DISTAL TIP OF THE INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) HAD COLLAPSED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE. THEREFORE, THE CATD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8).

  Patient problems: No Patient Involvement

  MAUDE report 7332910 ↗
• MalfunctionJan 16, 2018Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WAS FRACTURED AT THE HUB UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CATD WAS FOUND PRIOR TO USE, AND THEREFORE THE CATD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATD.

  Patient problems: No Patient Involvement

  MAUDE report 7197791 ↗
• MalfunctionDec 14, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Material Deformation; Device Damaged Prior to Use; Out-Of-Box Failure; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE DISTAL TIP OF AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS FLATTENED AND UNUSABLE UPON REMOVAL FROM THE PACKAGING. THE DAMAGED CATD WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD.

  Patient problems: No Patient Involvement

  MAUDE report 7117173 ↗
• MalfunctionDec 6, 2017Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUBCLAVIAN VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD). DURING THE PROCEDURE, THE PHYSICIAN PLACED AN 8F SHORT NON-PENUMBRA SHEATH INTO THE LEFT BRACHIAL VEIN, THEN INSERTED A CATD INTO THE SHEATH. THE PHYSICIAN THEN MADE FIVE TO SIX PASSES WITH THE CATD PULLING NEGATIVE WITH A 60 CC SYRINGE. IT WAS REPORTED THAT AFTER EACH PASS, THE PHYSICIAN PULLED THE CATD OUT UNDER MANUAL ASPIRATION THEN FLUSHED THE SYRINGE AND CATD ON THE BACK SCRUB TABLE. ON THE SEVENTH OR EIGHTH INSERTION OF THE CATD, THE PHYSICIAN PULLED NEGATIVE WITH THE 60 CC SYRINGE AND STARTED TO WITHDRAW THE CATD; HOWEVER, THE DISTAL END OF THE CATD SEPARATED FROM THE CATHETER. IT WAS REPORTED THAT THE CATD SEPARATED AT THE JUNCTION WHERE THE WHITE HUB PART OF THE CATHETER MEETS THE GREEN PART OF THE CATHETER ABOUT 30 CM FROM THE PROXIMAL TIP OF THE CATD. THE PHYSICIAN REINSERTED THE TIP BACK ONTO THE GREEN PORTION OF THE MAIN CATD AND WITHDREW THE ENTIRE CATD FROM THE BODY. THE PHYSICIAN THEN TESTED THE CATD ON THE BACK SCRUB TABLE, FLUSHING THE CATD AND PULLING NEGATIVE WITH A 60 CC SYRINGE AND DECIDED THE CATD WAS IN WORKING ORDER. THE CATD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088979 ↗
• MalfunctionNov 15, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Material Deformation; Device Damaged Prior to Use; Out-Of-Box Failure; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIPS OF AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) WERE PINCHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED CATD AND CAT6 WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USE IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW CAT6.

  Patient problems: No Patient Involvement

  MAUDE report 7035724 ↗
• MalfunctionNov 1, 2017Failure to Advance; Physical Resistance; Material Deformation; Failure to Advance; Physical Resistance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE CATD INTO A NON-PENUMBRA SHEATH, AND SAW THAT THE CATD APPEARED TO BE OVALIZED. THE PHYSICIAN THEREFORE REMOVED THE CATD AND CONFIRMED THE OVALIZATION. A SECOND CATD WAS THEN BROUGHT, BUT WAS FOUND TO BE OVALIZED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE SECOND CATD WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (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 6993658 ↗
• MalfunctionNov 1, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Material Deformation; Device Damaged Prior to Use; Out-Of-Box Failure; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER D (CATD). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE CATD INTO A NON-PENUMBRA SHEATH, AND SAW THAT THE CATD APPEARED TO BE OVALIZED. THE PHYSICIAN THEREFORE REMOVED THE CATD AND CONFIRMED THE OVALIZATION. A SECOND CATD WAS THEN BROUGHT, BUT WAS FOUND TO BE OVALIZED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE SECOND CATD WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6993656 ↗