Indigo System CAT8TORQ85Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00814548016252), received between Aug 13, 2015 and Aug 9, 2021 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Kinked” (10 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT PULMONARY EMBOLISM USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 THROUGH THE SHEATH, THEN INITIATED ASPIRATION. HOWEVER, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE DISTAL TIP OF THE CAT8 WAS KINKED IN THE MAIN PULMONARY ARTERY. THEREFORE, THE CAT8 WAS REMOVED. NEXT, THE PHYSICIAN CONTINUED ASPIRATION USING A NEURON MAX. THE PROCEDURE WAS COMPLETED BY ADMINISTERING TISSUE PLASMINOGEN ACTIVATOR (TPA) OVERNIGHT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297579 ↗
• MalfunctionJun 13, 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 NEAR THE HUB UPON REMOVAL FROM ITS PACKAGING. THE DAMAGE TO THE CAT8 OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696059 ↗
• MalfunctionMay 29, 2019Material Twisted/Bent; Material Twisted/Bent

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) BENT. 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 8650511 ↗
• MalfunctionMay 10, 2019Fracture; Device Damaged Prior to Use; Fracture; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND UPON OPENING THE STERILE PACKAGING THAT THE PROXIMAL END OF AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS FRACTURED. 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.

  Patient problems: No Patient Involvement

  MAUDE report 8601591 ↗
• MalfunctionMar 1, 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 OVALIZED AT THE DISTAL END UPON REMOVAL FROM THE PACKAGING. THE CAT8 WAS THEREFORE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8382275 ↗
• MalfunctionFeb 8, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF OBSERVED THAT THE TIP OF AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS FLATTENED UPON OPENING THE PACKAGE. 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.

  Patient problems: No Patient Involvement

  MAUDE report 8319870 ↗
• MalfunctionOct 11, 2018Material Puncture/Hole; Material Puncture/Hole

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS DAMAGED WHEN IT WAS REMOVED FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE; THEREFORE, THE CAT8 WAS NOT USED IN THE PROCEDURE. A PHOTOGRAPHIC IMAGE WAS PROVIDED, WHICH SHOWED A PUNCTURED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7958233 ↗
• MalfunctionSep 27, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE PASSES USING THE CAT8 AND A NON-PENUMBRA SHEATH. AFTER AT LEAST FOUR PASSES, THE PHYSICIAN NOTICED THAT THE TIP OF THE CAT8 HAD BECOME FLATTENED. THEREFORE, THE PHYSICIAN USED A NEW CAT8 AND THE SAME SHEATH TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916803 ↗
• MalfunctionSep 18, 2018Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE CAT8 BECAME BENT WHILE BEING INSERTED INTO THE NON-PENUMBRA SHEATH. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW CAT8 WITH THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886645 ↗
• MalfunctionAug 15, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, UPON INSERTION OF A CAT8 INTO A NON-PENUMBRA SHEATH, 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 7786829 ↗
• MalfunctionAug 9, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO RE-INSERT THE CAT8 INTO A NON-PENUMBRA SHEATH AND SUBSEQUENTLY, THE DISTAL TIP OF THE CAT8 BECAME KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH 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 7768197 ↗
• MalfunctionJun 25, 2018Bent; Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETERS 8 (CAT8S). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTED THAT TWO CAT8S WERE BENT WHEN THEY WERE INTRODUCED INTO THE OPENING OF THE SHEATH AND THEREFORE, THE CAT8S WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635677 ↗
• MalfunctionJun 25, 2018Bent; Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETERS 8 (CAT8S). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTED THAT TWO CAT8S WERE BENT WHEN THEY WERE INTRODUCED INTO THE OPENING OF THE SHEATH AND THEREFORE, THE CAT8S WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635668 ↗
• MalfunctionJun 13, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8S). DURING THE PROCEDURE, THE TIPS OF TWO CAT8S BECAME CRIMPED AS THE PHYSICIAN ATTEMPTED TO ADVANCE THEM INTO A NON-PENUMBRA CATHETER. THE CAT8S WERE THEREFORE NOT USED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599104 ↗
• MalfunctionMay 25, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 OVER A GUIDEWIRE WHILE PREPARING TO ADVANCE THE CAT8 INTO A SHEATH IN THE PATIENT; HOWEVER, THE PHYSICIAN NOTICED THAT THE TIP OF THE CAT8 WAS PINCHED. THE CAT8 WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7545565 ↗
• MalfunctionMay 25, 2018Device Damaged Prior to Use; Out-Of-Box Failure; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Out-Of-Box Failure; Tear, Rip or Hole in Device Packaging

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WAS TORN UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT8 WAS NOT USED IN THE PROCEDURE. THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 7545056 ↗
• MalfunctionApr 16, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL ARTERY USING AN INDIGO SYSTEM CAT8 ASPIRATION CATHETER (CAT8). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS WITHIN A NON-PENUMBRA SHEATH, AND THEN REMOVED THE CAT8 TO FLUSH IT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE TIP OF THE CAT8 WAS DEFORMED. THE CAT8 WAS THEREFORE NOT REUSED, 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 7433234 ↗
• MalfunctionFeb 26, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) INTO A NON-PENUMBRA SHEATH ON THE BACK TABLE AND CONSEQUENTLY, THE DISTAL TIP OF THE CAT8 BECAME KINKED. IT WAS REPORTED THAT THE CAT8 NEVER ENTERED THE SHEATH. THE CAT8 BECAME DAMAGED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH AND A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 7297854 ↗
• MalfunctionNov 29, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN FELT SOME RESISTANCE WHILE ADVANCING THE CAT8 THROUGH A NON-PENUMBRA SHEATH. THE CAT8 THEN BECAME KINKED AFTER MAKING ABOUT FIVE PASSES, AND THEREFORE THE CAT8 WAS REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE 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 7068055 ↗
• MalfunctionSep 15, 2017Failure to Advance; Aspiration Issue; Failure to Advance; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE CAT8 THROUGH A NON-PENUMBRA SHEATH, HOWEVER WAS UNABLE TO. THE PHYSICIAN THEREFORE REMOVED THE CAT8 AND THE SHEATH, AND INSERTED A NEW NON-PENUMBRA SHEATH. THE PHYSICIAN WAS THEN ABLE TO ADVANCE THE CAT8 INTO THE TARGET LOCATION, BUT FOUND THAT THE CAT8 WAS UNABLE TO ASPIRATE; THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6870818 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE ON (B)(6) 2016 USING AN INDIGO SYSTEM CAT 8 ASPIRATION CATHETER (CAT8). DURING THE PROCEDURE, THE PATIENT HAD A MASSIVE PULMONARY EMBOLISM (PE) WITH PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST WHICH LED TO THE PATIENT PASSING AWAY. THIS SERIOUS ADVERSE EVENT WAS ADJUDICATED TO BE DEFINITELY RELATED TO THE MASSIVE PULMONARY EMBOLISM, AND POSSIBLY, THOUGH UNLIKELY, RELATED TO THE INDIGO SYSTEM.

  Patient problems: Pulmonary Embolism

  MAUDE report 6673579 ↗
• MalfunctionMay 10, 2017Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Packaging Compromised; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Packaging Compromised

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED A CREASE AROUND THE MID/DISTAL SHAFT OF TWO INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8¿S) DEVICES UPON OPENING THE DEVICE PACKAGING BOX. UPON FURTHER EXAMINATION, IT WAS OBSERVED THAT THE BOX OF THE DEVICES WAS BENT RIGHT WHERE THE CREASE IN THE CAT8'S WERE OBSERVED. THE DAMAGED CAT8 DEVICES WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 6559016 ↗
• MalfunctionMay 10, 2017Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Packaging Compromised; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Packaging Compromised

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED A CREASE AROUND THE MID/DISTAL SHAFT OF TWO INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8¿S) DEVICES UPON OPENING THE DEVICE PACKAGING BOX. UPON FURTHER EXAMINATION, IT WAS OBSERVED THAT THE BOX OF THE DEVICES WAS BENT RIGHT WHERE THE CREASE IN THE CAT8''S WERE OBSERVED. THE DAMAGED CAT8 DEVICES WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 6559006 ↗
• MalfunctionApr 26, 2017Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN REPEATEDLY REMOVED AND REINSERTED THE CAT8 INTO THE NON-PENUMBRA SHEATH; CONSEQUENTLY, THE TIP OF THE CAT8 BECOME COMPRESSED DUE TO REPEATED INSERTION AND REMOVAL. THEREFORE, THE PHYSICIAN USED A SECOND NON-PENUMBRA SHEATH TO ACCESS A NEW VESSEL AND USED A NEW CAT8 TO CONTINUE THE PROCEDURE. HOWEVER, AFTER CONTINUAL REMOVAL AND REINSERTION, THE TIP OF THE SECOND CAT8 BECAME COMPRESSED AS WELL. IT WAS REPORTED THAT THE PHYSICIAN USED THE PEEL-AWAY INTRODUCER SHEATH AT ALL TIMES, THOUGH DID NOT ALWAYS USE A GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6524108 ↗
• MalfunctionApr 26, 2017Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN REPEATEDLY REMOVED AND REINSERTED THE CAT8 INTO THE NON-PENUMBRA SHEATH; CONSEQUENTLY, THE TIP OF THE CAT8 BECOME COMPRESSED DUE TO REPEATED INSERTION AND REMOVAL. THEREFORE, THE PHYSICIAN USED A SECOND NON-PENUMBRA SHEATH TO ACCESS A NEW VESSEL AND USED A NEW CAT8 TO CONTINUE THE PROCEDURE. HOWEVER, AFTER CONTINUAL REMOVAL AND REINSERTION, THE TIP OF THE SECOND CAT8 BECAME COMPRESSED AS WELL. IT WAS REPORTED THAT THE PHYSICIAN USED THE PEEL-AWAY INTRODUCER SHEATH AT ALL TIMES, THOUGH DID NOT ALWAYS USE A GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6524053 ↗