Indigo System CAT3KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948020535), received between Jul 15, 2020 and Sep 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY (ATA) USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3), A SHEATH, AND A GUIDEWIRE (.14). DURING THE PROCEDURE, WHILE ADVANCING THE CAT3 TO THE TARGET VESSEL, THE PHYSICIAN LOST TRACK OF THE RADIOPAQUE TIP OF THE CAT3 AND THEN NOTICED UNDER FLUOROSCOPY THAT THE MARKER HAD ALREADY REACHED BEYOND THE OCCLUDED SEGMENT OF THE ATA, REACHING THE DORSALIS PEDIS ARTERY. THE PHYSICIAN BEGAN RETRACTING THE CAT3 BUT NOTICED UNDER FLUOROSCOPY THAT THE RADIOPAQUE TIP OF THE CAT3 REMAINED IN THE DORSALIS PEDIS ARTERY. THE CAT3 WAS REMOVED AND UPON INSPECTION, THE PHYSICIAN NOTICED THAT APPROXIMATELY TWENTY CENTIMETERS OF THE DISTAL LENGTH OF THE CAT3 REMAINED IN THE PATIENT. THE PHYSICIAN PERFORMED A SURGICAL CUT-DOWN OF THE DORSALIS PEDIS ARTERY AND SUCCESSFULLY RETRIEVED THE FRACTURED SEGMENT OF THE CAT3. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT REMAINS HOSPITALIZED, UNDER OBSERVATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937494 ↗
• MalfunctionOct 28, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO REMOVE THE CAT3 TO COMPLETE THE PASS AND TAKE AN ANGIOGRAM. UPON RETRACTING THE CAT3 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE CAT3 BROKE APPROXIMATELY 5 INCHES FROM THE DISTAL TIP, OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) 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 12712092 ↗
• MalfunctionJul 15, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR AND ANTERIOR TIBIAL ARTERIES USING AN INDIGO SYSTEM ASPIRATION CATHETER 3 (CAT3) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE INTRODUCING THE CAT3 INTO THE SHEATH. SUBSEQUENTLY, THE CAT3 BROKE NEAR THE PROXIMAL END, OUTSIDE OF THE PATIENT'S BODY. THEREFORE, THE CAT3 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER 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 10279997 ↗