Indigo System SEP5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814548013329), received between Sep 3, 2015 and Sep 30, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 30, 2016Material Frayed; Physical Resistance; Difficult to Advance; Material Frayed; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TREATING AN OCCLUDED BYPASS GRAFT USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA SHEATH ALONG WITH A GUIDEWIRE TO THE TARGET VESSEL. WHILE CROSSING THE PROXIMAL CAP OF THE GRAFT, THE PHYSICIAN EXPERIENCED DIFFICULTY BUT WAS ABLE TO SUCCESSFULLY ADVANCE THE GUIDEWIRE. HOWEVER, THE PHYSICIAN DID NOT WANT TO LOSE GUIDEWIRE ACCESS AND ADVANCED A SECOND GUIDEWIRE SO THAT A BUDDY SYSTEM COULD BE USED WHILE USING THE PENUMBRA SYSTEM. THE PHYSICIAN THEN ADVANCED THE ACE 64 THROUGH THE SHEATH; HOWEVER, WHILE ADVANCING THE ACE 64,THE PHYSICIAN EXPERIENCED RESISTANCE NOTICED THAT THE TIP OF THE CATHETER BECAME KINKED. IT IS UNCLEAR WHEN THE KINK OCCURRED. CONSEQUENTLY, THE PHYSICIAN WAS UNABLE TO ADVANCE A SEPARATOR WIRE THROUGH THIS KINKED ACE 64 AND THEREFORE THE ACE 64 WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED AN INDIGO SYSTEM ASPIRATION CATHETER 5(CAT5) OVER THE GUIDEWIRE THEN REMOVED THE GUIDEWIRE BEFORE ADVANCING THE SEP5 THROUGH THE CAT5. AS THE ASPIRATION WAS INITIATED, THE PHYSICIAN MENTIONED EXPERIENCING RESISTANCE WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5992141 ↗
• MalfunctionDec 30, 2015Kinked; Failure to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) AND AN INDIGO SYSTEM SEPARATOR (SEP5). IN THE MIDDLE OF THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SEP5 THROUGH THE CAT5 AND REMOVED BOTH DEVICES FROM THE PATIENT. UPON REMOVING THE CAT5 AND SEP5 FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THEY WERE BOTH KINKED. THE PROCEDURE WAS COMPLETED USING A NEW CAT5 AND A NEW SEP5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5336566 ↗
• MalfunctionSep 3, 2015Fracture; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING THE INDIGO SYSTEM SEPARATOR 5 (SEP5). THE PHYSICIAN SUCCESSFULLY ASPIRATED THROMBUS USING THE SEP5 AND AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). THE PHYSICIAN REMOVED THE SEP5 AND CAT5 FROM THE PATIENT TO PERFORM BALLOON ANGIOPLASTY. BEFORE ADVANCING THE SEP5 BACK INTO THE PATIENT THE PHYSICIAN NOTICED THAT THE SEP5 HAD BECOME KINKED. THE SEP5 THEN BECAME FRACTURED WHILE THE PHYSICIAN ATTEMPTED TO STRAIGHTEN THE KINK, AND THE SEP5 WAS NOT USED FURTHER. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW SEP5. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5055371 ↗