Indigo CATD-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815948020481), received between Jul 28, 2020 and May 3, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE CATD. DURING THE NEXT PASS, THE PHYSICIAN KINKED THE DISTAL TIP OF THE CATD TWICE WHILE ADVANCING THE CATD IN THE AV FISTULA AT THE ANASTOMOSIS FROM THE VENOUS TO ARTERIAL. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD 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 11765400 ↗
• MalfunctionOct 20, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUDED ARTERIOVENOUS (AV) FISTULA USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, A PINNACLE SHEATH WAS PLACED IN THE DIALYSIS FISTULA. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AFTER ADVANCING THE CATD A FEW CENTIMETERS THROUGH THE SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE CATD AND NOTICED THE DISTAL TIP TO BE OVALIZED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THE SHEATH TO BE KINKED UNDER FLUOROSCOPY AND THE CATD BECAME DAMAGED UPON ADVANCING THROUGH THE KINKED SECTION OF THE SHEATH AND, THEREFORE, THE SHEATH WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND 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 10708694 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) FISTULA GRAFT USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD), A GUIDEWIRE AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATD OVER THE GUIDEWIRE THROUGH THE SHEATH FROM THE BRACHIAL ARTERY TO THE AV GRAFT AND ATTEMPTED TO PERFORM ASPIRATION USING THE CATD. HOWEVER, AFTER FIVE MINUTES, THE CATD WAS NOT ASPIRATING, AND THE PHYSICIAN REALIZED THE DISTAL END OF THE CATD WAS KINKED. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATD 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 10525737 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD), INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CATD THROUGH THE SHEATH, THE MID-SHAFT OF THE CATD KINKED. SUBSEQUENTLY, THE CATD WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING THE CATRX AND THE SHEATH. WHILE ADVANCING THE CATRX THROUGH THE SHEATH, THE PROXIMAL END OF THE CATRX KINKED. THEREFORE, THE CATRX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A INDIGO SYSTEM ASPIRATION CATHETER 8 (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 10522115 ↗
• MalfunctionJul 29, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE CATD THROUGH THE VALVE OF THE SHEATH USING A PEEL AWAY SHEATH AND COMPLETED APPROXIMATELY EIGHT TO TEN PASSES USING THE CATD. THE PHYSICIAN THEN REMOVED THE CATD AND NOTICED A KINK APPROXIMATELY TWO CENTIMETERS FROM THE DISTAL END OF THE CATD. IT WAS ALSO REPORTED THAT THE CATD WAS BEING AGGRESSIVELY TORQUED, ADVANCED AND RETRACTED. THE PROCEDURE WAS COMPLETED USING A 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 10339672 ↗
• MalfunctionJul 28, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT ILIAC ARTERIES USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES USING THE CATD AND SHEATH. WHILE INSERTING THE CATD INTO THE SHEATH FOR THE FOURTH PASS, THE TIP OF THE CATD KINKED. THE PHYSICIAN THEN ATTEMPTED TO RESOLVE THE KINK; HOWEVER, IT THEN OVALIZED AS WELL AT THE ANGLE OF THE CATD. THEREFORE, THE CATD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (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 10332247 ↗