Indigo System SEP3-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548016115), received between Apr 30, 2018 and May 18, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3), AN INDIGO SYSTEM SEPARATOR 3 (SEP3), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A CAT3 TO THE TARGET VESSEL AND INITIATED ASPIRATION. WHILE ASPIRATING, THE PHYSICIAN NOTICED THE CAT3 WAS GETTING CLOGGED UP WITH THROMBUS. THEREFORE, THE PHYSICIAN DECIDED TO USE A SEP3 TO ASSIST THE CAT3. HOWEVER, WHILE ADVANCING THE SEP3 THROUGH THE CAT3, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SEP3 EXITED THE SIDE WALL OF THE CAT3 INSTEAD OF THE DISTAL END; THEREFORE, THE CAT3 AND SEP3 WERE REMOVED. UPON REMOVAL OF THE CAT3, THE PHYSICIAN NOTICED THAT THE LUMEN OF THE CAT3 WAS PUNCTURED APPROXIMATELY A FEW INCHES PROXIMAL FROM THE DISTAL END. IT WAS NOTED THAT THE SEP3 WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A LYSIS CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842268 ↗
• MalfunctionOct 9, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RADIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 3 (SEP3). DURING THE PROCEDURE, THE PHYSICIAN MADE 10 PASSES USING THE SEP3 WITH AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND A NON-PENUMBRA SHEATH. WHILE RETRACTING THE SEP3, THE PHYSICIAN NOTICED THAT APPROXIMATELY 10 MILLIMETERS OF THE DISTAL TIP OF THE SEP3 HAD BROKEN OFF AND WAS STUCK IN THE REMAINING CLOT. THEREFORE, THE CAT3 AND SEP3 WERE REMOVED. THE PHYSICIAN THEN ADVANCED AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND SUCCESSFULLY ASPIRATED AND REMOVED THE BROKEN TIP OF THE SEP3. THE PROCEDURE WAS COMPLETED USING THE SAME CAT5 AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173476 ↗
• MalfunctionJul 8, 2019Device Fell; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 3 (SEP3). WHILE PREPARING A SEP3 FOR USE, THE HOSPITAL TECHNICIAN INADVERTENTLY DROPPED THE SEP3 ON THE GROUND AND, CONSEQUENTLY, THE SEP3 WAS CONTAMINATED. THE CONTAMINATION OF THE SEP3 OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS THEN CONTINUED USING A NEW SEP3.

  Patient problems: No Patient Involvement

  MAUDE report 8768045 ↗
• MalfunctionApr 5, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM SEPARATOR 3 (SEP3) AND AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SEP3 THROUGH THE CAT3. IT WAS REPORTED THAT THE SEP3 WAS KINKED AS THE PHYSICIAN WAS ADVANCING THE SEP3 THROUGH THE ROTATING HEMOSTASIS VALVE (RHV). THE SEP3 WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW SEP3 AND THE SAME CAT3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8488371 ↗
• MalfunctionApr 30, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND INDIGO SYSTEM SEPARATOR 3 (SEP3) WERE ACCIDENTALLY DROPPED ON THE FLOOR AND BECAME CONTAMINATED UPON REMOVAL FROM THE PACKAGING. THE CAT3 AND THE SEP3 WERE DROPPED PRIOR TO USE. THEREFORE, THEY WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW CAT3 AND SEP3 DEVICES.

  Patient problems: No Patient Involvement

  MAUDE report 7473971 ↗