Indigo SEPDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548017600), received between Apr 18, 2018 and Mar 6, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (3 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.

• InjuryMar 6, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN AN ARTERIOVENOUS (AV) GRAFT IN THE LEFT ARM USING AN INDIGO SYSTEM SEPARATOR D (SEPD) AND AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). IT SHOULD BE NOTED THAT ACCORDING TO THE PHYSICIAN, THE GRAFT HAD BEEN CLOTTED FOR TWO WEEKS OR MORE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SEPD AND AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) IN TANDEM. HOWEVER, IT WAS ALSO REPORTED THAT THE RESISTANCE FELT DURING ADVANCEMENT WAS NOTHING MORE THAN THE PHYSICIAN NORMALLY EXPECTS IN THESE PROCEDURES. AFTER MAKING SEVERAL PASSES IN THE TARGET VESSEL WITH THE TANDEM DEVICES, THE PENUMBRA SALES REPRESENTATIVE WAS LOOKING AT THE FLUOROSCOPIC VISUALIZATION AND REALIZED THAT THE DISTAL TIP OF THE SEPD WIRE HAD BROKEN OFF AND HAD BECOME EMBEDDED IN THE THROMBUS WITHIN THE PATIENT¿S ARM. THE DEVICES WERE THEN REMOVED FROM THE PATIENT AND THE MECHANICAL THROMBECTOMY PROCEDURE WAS ENDED. UNRELATED TO THE BROKEN PIECE OF WIRE, THE PHYSICIAN DECIDED TO TRANSFER THE PATIENT TO THE OPERATING ROOM (OR) FOR AN OPEN THROMBECTOMY PROCEDURE TO REMOVE THE HEAVY CLOT BURDEN. DURING THE OPEN THROMBECTOMY PROCEDURE THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8397529 ↗
• MalfunctionMay 31, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE INDIGO SYSTEM SEPARATOR D (SEPD) WAS INADVERTENTLY DROPPED BY SCRUB TECHNOLOGIST UPON REMOVAL FROM THE PACKAGING. THE REPORTED ISSUE WAS FOUND PRIOR TO USE AND THEREFORE, THE SEPD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT USING MORE DEVICES.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7557197 ↗
• MalfunctionMay 22, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE INDIGO SYSTEM SEPARATOR D (SEPD) AND THE INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WERE DROPPED ON THE FLOOR WHILE THE SEPD WAS LOADED INSIDE THE CATD. THE REPORTED ISSUE WAS FOUND PRIOR TO USE AND THEREFORE, THE SEPD AND THE CATD WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7535041 ↗
• MalfunctionApr 18, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE ON THE BACK TABLE, THE INDIGO SYSTEM SEPARATOR D (SEPD) WAS ACCIDENTALLY KNOCKED OFF THE TABLE ONTO THE FLOOR. THE SEPD FELL ON THE FLOOR PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD).

  Patient problems: No Patient Involvement

  MAUDE report 7441941 ↗