Indigo System SEPC4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548017594), received between Jan 11, 2019 and Nov 9, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PERONEAL ARTERY, LEFT ANTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 4 (SEP4), AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY REVASCULARIZED THE LEFT PERONEAL ARTERY BY USING THE CATRX AND THE SEP4. AFTERWARDS, THE PHYSICIAN ADVANCED THE CATRX TO THE LEFT ANTERIOR TIBIAL ARTERY WITH THE HELP OF A GUIDEWIRE AND ADVANCED THE SEP4 THROUGH THE CATRX. THE PHYSICIAN ENCOUNTERED RESISTANCE AS THE SEP4 WAS BEING ADVANCED 1-2 CM PAST THE DISTAL END OF THE CATRX DUE TO SIGNIFICANT CHRONIC THROMBUS IN THE VESSEL. AFTER COMPLETING A FEW PASSES, THE PHYSICIAN NOTICED THAT THE SEP4 BULB WAS NOT MOVING ALONG WITH ITS PUSHER WIRE. HE THEN SUCTIONED THE SEP4 BULB TO THE TIP OF THE CATRX. HE RETRACTED THE CATRX WITH ASPIRATION TURNED ON AND WAS ABLE TO REMOVE THE SEP4 AND THE BULB COMPLETELY FROM THE PATIENT'S VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW SEP4 AND THE SAME CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782770 ↗
• MalfunctionJan 11, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR MESENTERIC VEIN (SMV) USING AN INDIGO SYSTEM SEPARATOR 4 (SEP4). DURING THE PROCEDURE, THE PHYSICIAN MADE APPROXIMATELY 4 TO 5 PASSES USING THE SEP4 WITHIN AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). HOWEVER, THE BULB OF THE SEP4 BEGAN TO UNRAVEL AND, THEREFORE, THE SEP4 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SEP4 WITH THE SAME CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242332 ↗