Indigo System CAT8STR85KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948020436), received between Feb 18, 2020 and Aug 31, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE COMMON POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT HAD HEAVY CLOT BURDEN AND WAS UNCOOPERATIVE. DURING THE PROCEDURE, THE PEEL-AWAY INTRODUCER SHEATH WAS USED TO INTRODUCE THE CAT6 TO THE SHEATH. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED IMMEDIATELY UPON INTRODUCTION TO THE SHEATH AND THE DISTAL TIP OF A CAT6 BECAME OVALIZED. THEREFORE, THE CAT6 WAS REMOVED. NEXT, WHILE ADVANCING A CAT8 INTO THE SHEATH, THE SAME ISSUE OCCURRED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) 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 12399265 ↗
• MalfunctionFeb 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT8 OVER A GUIDEWIRE AND THROUGH THE SHEATH AND THE CAT8 WOULD NOT ADVANCE FURTHER THROUGH THE SHEATH. THEREFORE, THE CAT8 AND THE OTHER DEVICES WERE REMOVED. THE PROCEDURE WAS STOPPED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722102 ↗