Indigo System CAT5KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948020542), received between Jul 1, 2021 and Jul 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2021Stretched; Material Deformation; Stretched; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL BRANCH OF SUPERIOR MESENTRIC ARTERY (SMA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AND A NON-PENUMBRA SHEATH (6.5 FR STEERABLE). DURING THE PROCEDURE,THE PHYSICIAN MADE TWO PASSES SUCCESSFULLY WITH THE CAT6; HOWEVER DURING THE THIRD PASS WHILE ADVANCING THE CAT6 WITHOUT THE GUIDEWIRE, THE CAT6 KINKED AT THE DISTAL TIP. THEREFORE, THE CAT6 WAS REMOVED. AT THIS POINT THE PHYSICIAN DECIDED TO USE THE CAT5 AND UPON REMOVING THE CAT5 AFTER THE FIRST PASS, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE CAT5 WAS KINKED AND STRETCHED; THEREFORE THE CAT5 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104641 ↗