Indigo System CAT8TORQ85KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815948020412), received between Apr 3, 2020 and Sep 10, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionSep 10, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A FEMORAL DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY THREE TO FIVE PASSES IN THE TARGET VESSEL USING THE CAT8. WHILE ATTEMPTING TO MAKE ANOTHER PASS USING THE CAT8, THE PHYSICIAN HEARD A HISSING SOUND WHILE PERFORMING A CORING TECHNIQUE. SUBSEQUENTLY, THE PHYSICIAN NOTICED THE CAT8 WAS BROKEN AT THE HUB; 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 10517653 ↗
• InjuryJun 11, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT HAD A STENT PLACED IN THE LEFT ILIAC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 INTO THE SFA AND TORQUED THE CAT8 SEVERAL TIMES TO ASPIRATE THE CLOT. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE TORQUEING THE CAT8 IN ONE DIRECTION AND EXPERIENCED RESISTANCE WHILE TORQUEING BACK THE OTHER DIRECTION. SUBSEQUENTLY, THE CAT8 BECAME FRACTURED AND APPROXIMATELY 12 CENTIMETERS OF THE CAT8 DISTAL TIP BROKE OFF. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE FRACTURED PIECE OF THE CAT8. 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 10146150 ↗
• MalfunctionMay 27, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT8 THROUGH THE SHEATH, AND SUBSEQUENTLY, THE CAT8 KINKED; THEREFORE, THE CAT8 WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW CAT8 THROUGH THE SHEATH; HOWEVER, THE SAME ISSUE OCCURRED THEREFORE, THE CAT8 WAS REMOVED. IT WAS REPORTED THAT THE SHEATH WAS KINKED WHICH LEAD THE TWO CAT8S TO KINK WHEN ADVANCED THROUGH. 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 10094439 ↗
• MalfunctionMay 14, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT8 THROUGH THE SHEATH AND SUBSEQUENTLY, THE DISTAL END OF THE CAT8 KINKED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND A NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10054823 ↗
• MalfunctionApr 3, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CAT8 KINKED WHILE PASSING THROUGH THE SHEATH AT THE ILIAC BIFURCATION. 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 Consequences Or Impact To Patient

  MAUDE report 9919445 ↗