Indigo System CAT8STR85Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548016269), received between Feb 1, 2016 and Dec 10, 2020 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (6 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.

• InjuryDec 10, 2020Break; Unraveled Material; Break; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). IT WAS NOTED THAT A STENT THAT WAS PREVIOUSLY PLACED IN THE PATIENT BECAME OCCLUDED WITH THROMBUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT8. HOWEVER, THE PREVIOUSLY PLACED STENT HAD COLLAPSED SLIGHTLY WHEN ASPIRATION WAS TURNED ON. SUBSEQUENTLY, WHILE TURNING THE CAT8 IN THE VESSEL, THE PHYSICIAN NOTICED THE TIP OF THE CAT8 BECAME CAUGHT AT THE PROXIMAL END OF THE STENT. CONSEQUENTLY, THE DISTAL RADIO-OPAQUE MARKER BAND OF THE CAT8 BECAME UNRAVELED AND BROKE OFF WITHIN THE PATIENT. THE CAT8 WAS THEN REMOVED AND THE PHYSICIAN DECIDED TO PLACE ANOTHER STENT INSIDE OF THE PREVIOUSLY PLACED STENT. IT WAS ALSO REPORTED THAT BY PLACING THE ADDITIONAL STENT, IT TRAPPED AND SECURED THE BROKEN MARKER BAND OF THE CAT8 IN PLACE. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10988714 ↗
• MalfunctionOct 17, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEINS USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES USING THE CAT8 WITH A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE CAT8 WAS FLUSHED AFTER BOTH PASSES. AFTER MAKING A THIRD PASS, THE PHYSICIAN REMOVED THE CAT8 AND FOUND THE DISTAL TIP TO BE OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 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 9204659 ↗
• MalfunctionJul 9, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) BECAME KINKED UPON REMOVAL FROM THE 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 CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8771191 ↗
• MalfunctionApr 26, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THE DISTAL TIP OF THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) TO BE OVALIZED IN TWO POINTS UPON REMOVAL FROM 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 A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 8557770 ↗
• MalfunctionJan 11, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) BECAME OVALIZED AT THE DISTAL TIP. 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 8241785 ↗
• MalfunctionJun 14, 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 TECHNICIAN ACCIDENTALLY KINKED THE INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT8 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8.

  Patient problems: No Patient Involvement

  MAUDE report 7601444 ↗
• MalfunctionMay 25, 2018Bent; Device Damaged Prior to Use; Device Handling Problem; Bent; Device Damaged Prior to Use; Device Handling Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 7545797 ↗
• MalfunctionMay 7, 2018Kinked; Device Damaged Prior to Use; Device Handling Problem; Kinked; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WHILE REMOVING IT FROM THE PACKAGING ON THE BACK TABLE. THE KINKING OF 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 7491797 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN EXTENSIVE BILATERAL PULMONARY EMBOLI USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA SHEATH WITH A NON-PENUMBRA GUIDE WIRE INTO THE LEFT MAIN PULMONARY ARTERY. NEXT, THE PHYSICIAN PLACED A GUIDE CATHETER OVER A 0.035" GUIDEWIRE AND THEN EXCHANGED THE VASCULAR SHEATH FOR A LONG GUIDING SHEATH OVER A 0.035" GUIDEWIRE. THEREAFTER, THE PHYSICIAN ADVANCED THE CAT8 THROUGH THE SHEATH AND PERFORMED SEVERAL PASSES. HOWEVER, THE POST MECHANICAL THROMBECTOMY PULMONARY ANGIOGRAM STUDY REVEALED A LACK OF RESPONSE TO THE THROMBECTOMY EVEN AFTER SEVERAL PASSES. SUBSEQUENTLY, A DECISION WAS MADE TO CONTINUE THE PROCEDURE WITH A CATHETER DIRECTED THROMBOLYSIS UTILIZING AN ULTRASONIC ASSISTED THROMBOLYTIC CATHETER (I.E. EKOS). THEREFORE, A LYTIC CATHETER WAS ADVANCED INTO THE LEFT PULMONARY ARTERY AND THE PHYSICIAN USED A NON-PENUMBRA CATHETER TO SELECT THE RIGHT MAIN PULMONARY ARTERY. A THROMBOLYTIC CATHETER WAS THEN ADVANCED ALONG THE RIGHT PULMONARY ARTERY. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS SCHEDULED TO BE INFUSED THROUGH THE CATHETER AND HEPARIN WAS SCHEDULED TO

  Patient problems: Cyanosis; High Blood Pressure/ Hypertension; Hypoxia

  MAUDE report 6953630 ↗
• MalfunctionJun 7, 2016Kinked; 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 TWO INDIGO SYSTEM ASPIRATION CATHETER 8 DEVICES (CAT8) WERE KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED CAT8 DEVICES WERE FOUND PRIOR TO USE AND THEREFORE, WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 5704847 ↗
• MalfunctionFeb 1, 2016Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A DEEP VEIN THROMBOSIS (DVT) USING INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) DEVICES. DURING THE PROCEDURE, WHILE TWO CAT8 DEVICES WERE BEING ADVANCED BACK TO BACK THROUGH ANOTHER MANUFACTURER'S SHEATH, THEY BOTH BECAME OVALIZED AT THE DISTAL TIP AND WERE BOTH REMOVED FROM THE PATIENT. 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 5403146 ↗