Indigo System CAT3Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548013299), received between Sep 23, 2015 and Dec 13, 2016 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2016Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 3 (CAT3) AND AN INDIGO SYSTEM SEPARATOR 3 (SEP3). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED A LITTLE RESISTANCE WHILE ADVANCING THE SEP3 THROUGH THE CAT3 DURING USE. UPON REMOVAL TO CHECK ON THE PROGRESS OF THE PROCEDURE, THE PHYSICIAN NOTICED THE SEP3 AND THE CAT3 HAD BECOME KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW SEP3, A NEW CAT3, 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 6171797 ↗
• MalfunctionApr 28, 2016Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THE INDIGO SYSTEM ASPIRATION CATHETER 3 (CAT3) WAS BROKEN. THE BROKEN CAT3 WAS FOUND PRIOR TO USE; THEREFORE, IT WAS NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 5618159 ↗
• MalfunctionMar 8, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 3 (CAT3). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING AN INDIGO SYSTEM SEPARATOR 3 (SEP3) THROUGH THE TIP OF THE CAT3 AND NOTICED THAT THE CAT3 WAS KINKED. THE CAT3 WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW CAT3 AND THE SAME SEP3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5485934 ↗
• MalfunctionMar 4, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY USED AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) TO REMOVE CLOT AND DECIDED TO USE THE CAT3 TO REMOVE A DISTAL CLOT. HOWEVER, THE PHYSICIAN WAS UNABLE TO ESTABLISH BLOOD FLOW AND UPON REMOVAL OF THE CAT3 FROM THE PATIENT, A KINK WAS OBSERVED. THE PHYSICIAN DECIDED TO TREAT THE PATIENT WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) FOR ANOTHER NIGHT AND THEN RETREAT THE PATIENT THE NEXT DAY USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5). THE CAT5 PERFORMED AS INTENDED AND THE PHYSICIAN WAS ABLE TO REMOVE CLOT IN THE TIBIAL ARTERY; HOWEVER, THE PATIENT CONTINUED TO CLOT BECAUSE HIS ANTICOAGULATION MEDICATIONS WERE NOT EFFECTIVE. FOLLOWING THE PROCEDURE, THE PATIENT WAS GOING TO SEE A VASCULAR SURGEON. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5481616 ↗
• MalfunctionFeb 25, 2016Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND AN INDIGO SYSTEM SEPARATOR 3 (SEP3). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SEP3 THROUGH THE CAT3 AND REMOVED THE SEP3 FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SEP3 THROUGH THE SAME CAT3 BUT WAS UNSUCCESSFUL AND DECIDED TO REMOVE BOTH DEVICES. UPON INSPECTION OF THE CAT3, NO KINKS WERE OBSERVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT3 AND THE SECOND SEP3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5460472 ↗
• MalfunctionJan 21, 2016Material Separation; Split; Material Separation; Split

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, WHILE ANOTHER MANUFACTURER'S GUIDEWIRE WAS BEING RE-ADVANCED THROUGH THE CAT3 IN ORDER TO MAINTAIN ACCESS AND BALLOONING AFTER THE ASPIRATION PROCESS, THE CAT3 WAS PENETRATED AND SPLIT OPEN. THE PHYSICIAN REMOVED THE CAT3 AND THE GUIDEWIRE FROM THE PATIENT AND COMPLETED THE PROCEDURE USING A NEW CAT3 AND A NEW GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5383454 ↗
• InjuryJan 8, 2016Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY REMOVED THE CLOT USING THE CAT3. AFTER REMOVAL OF THE CLOT, THE PHYSICIAN NOTICED THAT THE CAT3 BROKE IN HALF WHILE IN THE PATIENT'S LEG. THE PHYSICIAN REQUIRED A SNARE DEVICE TO REMOVE BOTH BROKEN HALVES OF THE CAT3 FROM THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5355418 ↗
• MalfunctionSep 23, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 3 (CAT3). DURING THE PROCEDURE, THE CAT3 WAS "SQUEEZED" AROUND THE WIRE AND WAS UNABLE TO ADVANCE THROUGH THE CLOT. BOTH THE CAT3 AND WIRE WERE REMOVED FROM THE PATIENT AND THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW WIRE AND A BALLOON. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5098279 ↗