Indigo System CAT5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548013305), received between Oct 29, 2015 and Apr 13, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Kinked” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN ATTEMPTED TO LOAD AN INDIGO SYSTEM SEPARATOR 5 (SEP5) INTO AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER 5(CAT5) ON THE BACK TABLE; HOWEVER, THE SEP5 WOULD NOT ADVANCE INTO THE CAT5 DUE TO A KINK ON THE CAT5. THEREFORE, THE CAT5 AND SEP5 WERE SET ASIDE AND THE PROCEDURE WAS COMPLETED USING AN INDIGO ASPIRATION SYSTEM CATHETER 6 (CAT6) AND INDIGO ASPIRATION CAT3 SYSTEM CATHETER (CAT3). THERE WAS NO NOTED DAMAGE TO THE SEP5 AFTER REMOVAL. THE PHYSICIAN DID NOT HAVE ANOTHER CAT5 TO USE WITH THE SEP5.

  Patient problems: No Patient Involvement

  MAUDE report 7430844 ↗
• MalfunctionNov 28, 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, AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) WAS KINKED UPON REMOVAL FROM THE HOOP. THE DAMAGE TO THE CAT5 WAS NOTICED PRIOR TO USE; THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT5.

  Patient problems: No Patient Involvement

  MAUDE report 6129214 ↗
• MalfunctionMar 31, 2016Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, THE CAT5 BECAME BUCKLED WHILE IT WAS BEING ADVANCED THROUGH ANOTHER MANUFACTURER'S SHEATH FOR THE SECOND PASS. THE PROCEDURE WAS STILL SUCCESSFULLY COMPLETED USING THE SAME CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5539861 ↗
• MalfunctionDec 30, 2015Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) AND AN INDIGO SYSTEM SEPARATOR (SEP5). IN THE MIDDLE OF THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SEP5 THROUGH THE CAT5 AND REMOVED BOTH DEVICES FROM THE PATIENT. UPON REMOVING THE CAT5 AND SEP5 FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THEY WERE BOTH KINKED. THE PROCEDURE WAS COMPLETED USING A NEW CAT5 AND A NEW SEP5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5336494 ↗
• MalfunctionOct 29, 2015Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5). DURING THE PROCEDURE, WHILE ASPIRATING THE THROMBUS, THE CAT5 SEPARATED AND BROKE AT THE POINT WHERE THE CATHETER AND THE "KINK RESISTANT STEEL" (STRAIN RELIEF) NEAR THE HUB MEET. THE PHYSICIAN MANUALLY REMOVED THE BROKEN CAT5 AND THE PROCEDURE CONTINUED USING A NEW CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5189942 ↗