Indigo System SEP3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548013312), received between Feb 25, 2016 and Jan 19, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2018Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES USING AN INDIGO SYSTEM SEPARATOR 3 (SEP3). DURING THE PROCEDURE, AFTER USING THE SEP3 WITH AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3), THE PHYSICIAN REMOVED THE SEP3 TO CLEAN THE DEVICE. THE PHYSICIAN THEN WANTED TO REMOVE THE TORQUE DEVICE FROM THE SEP3 IN ORDER TO INSERT THE SEP3 BACK THROUGH THE DISPOSABLE SHEATH AND INTO THE CAT3; HOWEVER, THE TORQUE DEVICE WOULD NOT COME OFF OF THE SEP3. THEREFORE, THE SEP3 WAS NOT REINSERTED INTO THE CAT3 AND A NEW SEP3 WAS OPENED. HOWEVER, THE PHYSICIAN ENCOUNTERED THE SAME ISSUE WHEN TRYING TO REMOVE THE TORQUE DEVICE FROM THE SECOND SEP3. AT THIS POINT, THE PHYSICIAN WAS ABLE TO REMOVE PART OF THE THROMBUS AND DECIDED TO REMOVE THE CAT3. THE PATIENT WAS THEN PLACED ON TISSUE PLASMINOGEN ACTIVATOR (TPA) OVER NIGHT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7208429 ↗
• MalfunctionJan 19, 2018Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES USING AN INDIGO SYSTEM SEPARATOR 3 (SEP3). DURING THE PROCEDURE, AFTER USING THE SEP3 WITH AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3), THE PHYSICIAN REMOVED THE SEP3 TO CLEAN THE DEVICE. THE PHYSICIAN THEN WANTED TO REMOVE THE TORQUE DEVICE FROM THE SEP3 IN ORDER TO INSERT THE SEP3 BACK THROUGH THE DISPOSABLE SHEATH AND INTO THE CAT3; HOWEVER, THE TORQUE DEVICE WOULD NOT COME OFF OF THE SEP3. THEREFORE, THE SEP3 WAS NOT REINSERTED INTO THE CAT3 AND A NEW SEP3 WAS OPENED. HOWEVER, THE PHYSICIAN ENCOUNTERED THE SAME ISSUE WHEN TRYING TO REMOVE THE TORQUE DEVICE FROM THE SECOND SEP3. AT THIS POINT, THE PHYSICIAN WAS ABLE TO REMOVE PART OF THE THROMBUS AND DECIDED TO REMOVE THE CAT3. THE PATIENT WAS THEN PLACED ON TISSUE PLASMINOGEN ACTIVATOR (TPA) OVER NIGHT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7208421 ↗
• MalfunctionDec 13, 2016Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 3 (CAT3) AND AN INDIGO SYSTEM SEPARATOR 3 (SEP3). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED A LITTLE RESISTANCE WHILE ADVANCING THE SEP3 THROUGH THE CAT3 DURING USE. UPON REMOVAL TO CHECK ON THE PROGRESS OF THE PROCEDURE, THE PHYSICIAN NOTICED THE SEP3 AND THE CAT3 HAD BECOME KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW SEP3, A NEW CAT3, AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6171795 ↗
• MalfunctionFeb 25, 2016Difficult 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) AND AN INDIGO SYSTEM SEPARATOR 3 (SEP3). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SEP3 THROUGH THE CAT3 AND REMOVED THE SEP3 FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SEP3 THROUGH THE SAME CAT3 BUT WAS UNSUCCESSFUL AND DECIDED TO REMOVE BOTH DEVICES. UPON INSPECTION OF THE CAT3, NO KINKS WERE OBSERVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT3 AND THE SECOND SEP3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5460532 ↗