Indigo System SEP7-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948024014), received between Sep 3, 2021 and May 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMay 14, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 7 (SEP7) AND AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED MULTIPLE PASSES IN THE TARGET LOCATION USING THE CAT7 AND SEP7. WHILE MAKING ANOTHER PASS, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE SEP7 HAD FRACTURED IN THE POPLITEAL ARTERY. THEREFORE, THE SEP7 WAS REMOVED FROM THE PATIENT AND THE FRACTURED PORTION WAS SUCCESSFULLY ASPIRATED OUT USING THE CAT7. THE PROCEDURE WAS COMPLETED USING A NEW SEP7 AND THE SAME CAT7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315742 ↗
• MalfunctionJan 31, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A BRACHIOCEPHALIC FISTULA USING AN INDIGO SYSTEM SEPARATOR 7 (SEP7) AND AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE SEP7 AND CAT7. DURING THE THIRD PASS, THE BULB OF THE SEP7 BROKE OFF INTO THE FISTULA. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN BULB OF THE SEP7. THE PROCEDURE WAS COMPLETED AT THIS POINT. IT WAS REPORTED THAT THE THROMBUS WAS OLD AND CHRONIC, AND THE FISTULA NEEDED TO BE ABANDONED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13405546 ↗
• MalfunctionDec 3, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM SEPARATOR 7 (SEP7). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE SEP7 INTO A ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE SEP7 AT THE PROXIMAL END. THEREFORE, THE SEP7 WAS REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT A SEP7 USING THE SAME RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12926996 ↗
• MalfunctionSep 3, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM SEPARATOR 7 (SEP7), AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE SEP7 AND CAT7. WHILE ADVANCING THE SEP7 THROUGH THE SHEATH TO MAKE THE NEXT PASS AND THE PROXIMAL END OF THE SEP7 WIRE BECAME KINKED. THEREFORE, THE SEP7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE CAT7 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12424956 ↗