Indigo System CAT8XTORQ115Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00814548016290), received between Sep 18, 2015 and Mar 31, 2021 — classified as 2 deaths, 4 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Kinked” (32 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 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING THE CAT8 INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PHYSICIAN KINKED THE CAT8. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11600620 ↗
• MalfunctionDec 20, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN AND BRACHIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET LOCATION USING THE CAT8. SUBSEQUENTLY, WHEN THE PHYSICIAN REMOVED THE CAT8 FOR FLUSHING, THE PHYSICIAN FOUND THE CAT8 WAS DAMAGED AT THE DISTAL END. THEREFORE, THE CAT8 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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; No Consequences Or Impact To Patient

  MAUDE report 11043093 ↗
• MalfunctionJul 2, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC VEIN AND INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), INDIGO SYSTEM SEPARATOR 8 (SEP8) AND, NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES USING THE CAT8. NEXT, WHILE ATTEMPTING TO ADVANCE A SEP8 THROUGH THE CAT8, THE PHYSICIAN NOTICED THE SEP8 WOULD NOT ADVANCE. THEREFORE, THE CAT8 WAS REMOVED AND THE PHYSICIAN NOTICED THE MID-SHAFT TO BE CRIMPED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8, THE SAME SEP8 AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10227315 ↗
• MalfunctionMar 20, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE INSERTING THE CAT8 INTO THE SHEATH. SUBSEQUENTLY, THE CAT8 BECAME KINKED; THEREFORE, IT 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 9863068 ↗
• MalfunctionFeb 13, 2020Break; Break

  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 COMPLETED TWO PASSES IN THE TARGET VESSEL USING THE CAT8 AND SHEATH. WHILE USING THE CAT8 UNDER ASPIRATION ON THE THIRD PASS, THE PHYSICIAN NOTICED THAT THE HUB OF THE CAT8 HAD BROKEN; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 9707929 ↗
• MalfunctionOct 7, 2019Difficult to Remove; Failure to Advance; Physical Resistance/Sticking; Difficult to Remove; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY AND FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS VERY TORTUOUS WITH MANY COLLATERALS. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE NON-PENUMBRA SHEATH IN THE TARGET VESSEL AND INTRODUCED THE CAT8. HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE CAT8 BECAME STUCK IN THE SHEATH. WHILE ATTEMPTING TO RETRACT THE CAT8 FROM THE SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE BEFORE INADVERTENTLY REMOVING THE CAT8 AND SHEATH TOGETHER FROM THE PATIENT. THE PHYSICIAN THEN MADE THE DECISION TO END THE PROCEDURE AND CONTINUE AT A LATER DATE WITH A DIFFERENT APPROACH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163543 ↗
• MalfunctionSep 24, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM CAT 8 ASPIRATION CATHETER (CAT8). DURING THE PROCEDURE, WHILE ADVANCING THE SEP8 IN AND OUT OF THE CAT8 IN THE TARGET VESSEL, THE SEP8 BECAME STUCK IN THE CAT8; THEREFORE, THE SEP8 AND CAT8 WERE REMOVED TOGETHER AS ONE UNIT. UPON REMOVAL, THE DISTAL TIP OF THE CAT8 WAS NOTICED TO BE KINKED. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110054 ↗
• MalfunctionAug 28, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SEP8 THROUGH THE CAT8. SUBSEQUENTLY, THE SEP8 BECAME STUCK AT THE DISTAL END OF THE CAT8. THE SEP8 AND CAT8 WERE THEN REMOVED TOGETHER FROM THE PATIENT AND WERE NO LONGER USED IN THE PROCEDURE. UPON REMOVAL OF THE CAT8, THE PHYSICIAN NOTED A SMALL PINCH IN THE CATHETER AT THE DISTAL END. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941123 ↗
• MalfunctionJul 17, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, AS THE PHYSICIAN WAS PASSING THE CAT8 THROUGH THE SHEATH, THE CAT8 KINKED. THE PHYSICIAN WAS ABLE TO SUCTION THE CLOT THROUGH THE CAT8 AND PASS THE SEP8 THROUGH THE DAMAGED PORTION OF THE CAT8 UNTIL IT WAS NO LONGER ABLE TO ADVANCE AT ALL DUE TO THE DAMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A NEW CAT8 AND SEP8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800607 ↗
• MalfunctionJun 19, 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 DISTAL TIP OF AN INDIGO SYSTEM ASPIRATION CATHETER (CAT8) WAS KINKED UPON OPENING OF THE PACKAGE. THE DAMAGED CAT8 WAS FOUND PRIOR TO USE, AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8712261 ↗
• MalfunctionJun 7, 2019Material Deformation; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS INADVERTENTLY KINKED ON THE BACK TABLE. THE DAMAGE TO THE CAT8 OCCURRED PRIOR TO USE AND, THEREFORE, THE CAT8 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8679541 ↗
• MalfunctionApr 24, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF THE CAT8 WAS KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545375 ↗
• MalfunctionApr 17, 2019Collapse; Collapse

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE SUCCESSFUL PASSES USING THE CAT8 WITH THE SEP8 AND A NON-PENUMBRA SHEATH. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL TIP OF THE CAT8 WAS COLLAPSING; THEREFORE THE CAT8 WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS ADVANCING THE SEP8, RESISTANCE WAS MET AFTER THE CAT8 COLLAPSED AND BECAME OVALIZED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8 THE SAME SEP8 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 8525054 ↗
• MalfunctionApr 12, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FOUND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) TO BE BROKEN BETWEEN THE HUB AND THE CATHETER UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8510133 ↗
• MalfunctionApr 5, 2019Material Deformation; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, IT WAS REPORTED THAT AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS FOUND TO BE KINKED MID-SHAFT AFTER REMOVAL FROM THE PACKAGING, WHILE PASSING THE CAT8 TO THE TABLE. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE AND THEREFORE WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8489249 ↗
• MalfunctionMar 22, 2019Collapse; Stretched; Material Deformation; Collapse; Stretched; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS WITH THE CAT8 INSIDE A NON-PENUMBRA SHEATH. UPON REMOVAL OF THE CAT8, THE HOSPITAL STAFF NOTICED THAT THE CAT8 WAS STRETCHED, KINKED AND CRUSHED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8445921 ↗
• MalfunctionMar 22, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS FOUND TO BE KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8445498 ↗
• MalfunctionMar 8, 2019Device Fell; Device Fell

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), THE CAT8 WAS ACCIDENTALLY DROPPED ON THE FLOOR AND BECAME UNSTERILE. THE CAT8 WAS THEREFORE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8404846 ↗
• MalfunctionJan 11, 2019Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) HAD BEEN CRUSHED AT THE MIDDLE OF THE CATHETER, BEFORE REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8241909 ↗
• MalfunctionJan 3, 2019Stretched; Device Damaged Prior to Use; Stretched; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS STRETCHED AT THE TIP UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8214352 ↗
• MalfunctionDec 31, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN TO AN IVC FILTER USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE SUCCESSFUL PASSES USING THE CAT8 WITH A NON-PENUMBRA SHEATH. AFTER APPROXIMATELY AN HOUR OF TORQUING, THE PHYSICIAN REMOVED THE CAT8 AND FOUND THE PROXIMAL END TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 WITH THE SAME SHEATH. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206836 ↗
• MalfunctionDec 12, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, WHILE ADVANCING THE CAT8 OVER A GUIDEWIRE THROUGH A STEEP AND TORTUOUS, CURVED VESSEL, THE CAT8 BECAME KINKED AT THE DISTAL TIP, AND THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS 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 8155202 ↗
• MalfunctionDec 11, 2018Material Deformation; Material Twisted/Bent; Physical Resistance/Sticking; Material Deformation; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING PREPARATION FOR THE PROCEDURE, THE CAT6 WAS ACCIDENTALLY DROPPED ON THE FLOOR PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE CONTINUED USING A NEW CAT6 AND REVASCULARIZATION OF THE SFA WAS ACHIEVED. LATER IN THE PROCEDURE, THE PHYSICIAN DECIDED TO UPSIZE THE SHEATH TO A 8F SHEATH AND USE A CAT8 IN THE ILIAC ARTERY. HOWEVER, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE CAT8 INTO THE SHEATH AND IT BECAME TWISTED, KINKED, AND OVALIZED APPROXIMATELY TWO CENTIMETERS FROM THE DISTAL TIP. THEREFORE, THE CAT8 WAS REMOVED AND THE PROCEDURE WAS 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 8153060 ↗
• MalfunctionDec 10, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE TIP OF AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) BECAME DAMAGED AS THE CAT8 WAS REMOVED FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE AND PRIOR TO PATIENT INVOLVEMENT. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8148204 ↗
• MalfunctionNov 14, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) HAD TWO MAJOR KINKS BEFORE REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8069383 ↗