Indigo System CAT8XTORQ115-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948022478), received between Dec 17, 2020 and Sep 7, 2021 — classified as 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CAT8 KINKED WHILE ADVANCING THROUGH THE SHEATH. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE COMPLETED USING A NEW CAT8 WITH A PEEL AWAY SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435983 ↗
• MalfunctionMay 30, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE HUB OF THE CAT8 BROKE WHILE TORQUING. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905884 ↗
• MalfunctionMar 16, 2021Material Deformation; Suction Failure; Material Deformation; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DEEP FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CAT8 DID NOT ASPIRATE AND SUBSEQUENTLY, THE PHYSICIAN NOTICED THE CAT8 WAS FLATTENED IN TWO LOCATIONS MID-SHAFT. IT WAS UNKNOWN WHETHER THE DAMAGE OCCURRED UPON REMOVAL FROM THE PACKAGING OR WHILE ATTEMPTING TO ASPIRATE. THEREFORE, THE CAT8 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 11497930 ↗
• MalfunctionDec 17, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY (CFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8, A NON-PENUMBRA SHEATH AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE THE PHYSICIAN ADVANCED THE CAT8 OVER THE GUIDEWIRE TO THE BIFURCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, APPROXIMATELY FIFTEEN CENTIMETERS FORM THE HUB OF THE CAT8 KINKED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A NON-PENUMBRA 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 11032494 ↗