Indigo System CAT8TORQ85KIT-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815948022508), received between May 27, 2020 and May 13, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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.

• MalfunctionMay 13, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN ARTERY USING INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT8 INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE CAT8 KINKED NEAR THE HUB; 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11816194 ↗
• MalfunctionNov 15, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL VEIN (SFV) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER INSERTING THE CAT8 INTO THE SHEATH; CONSEQUENTLY, THE MID SHAFT OF THE CAT8 BECAME KINKED. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10841727 ↗
• MalfunctionOct 27, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT COMMON ILIAC ARTERY USING INDIGO SYSTEM ASPIRATION CATHETER 8S (CAT8S) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT8 INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE DISTAL END OF THE CAT8 KINKED. SUBSEQUENTLY, THE CAT8 WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING A SECOND CAT8 AND COMPLETED FIVE PASSES. WHILE ATTEMPTING TO MAKE THE NEXT PASS, THE PHYSICIAN NOTICED THE CAT8 WAS UNABLE TO ASPIRATE THE THROMBUS. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER AND THROMBOLYTIC THERAPY. 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 10744464 ↗
• MalfunctionAug 25, 2020Suction Problem; Material Deformation; Suction Problem; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE CAT8 INTO THE SHEATH USING THE PEEL-AWAY SHEATH. WHILE ASPIRATING WITH THE CAT8, IT BECAME CLOGGED AND THE PHYSICIAN DECIDED TO REMOVE IT. UPON REMOVAL, IT WAS NOTICED THAT THE TIP OF THE CAT8 WAS OVALIZED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA THROMBECTOMY SYSTEM 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 10451071 ↗
• 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 10094434 ↗