Indigo System SEP7D-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815948023994), received between Sep 13, 2022 and Feb 18, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A BRACHYCEPHALIC FISTULA USING AN INDIGO SYSTEM SEPARATOR 7D (SEP7D), AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D), AND A NON-PENUMBRA INTRODUCER SHEATH. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE SEP7D AND CAT7D. THE PHYSICIAN THEN OBSERVED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP7D HAD FRACTURED AND WAS EMBEDDED IN THE VESSEL WALL. THEREFORE, THE SEP7D WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ASPIRATE THE WIRE OF THE SEP7D USING THE CAT7D, WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO LEAVE THE WIRE OF THE SEP7D IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM SEPARATOR 7 (SEP7) AND THE SAME CAT7D.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21403824 ↗
• MalfunctionAug 28, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A LARGE THROMBUS IN THE ARTERIOVENOUS FISTULA (AVF) USING AN INDIGO SYSTEM SEPARATOR 7D (SEP7D), INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D), NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ADVANCING THE SEP7D TO REMOVE A LOT OF CLOT BURDEN IN THE TARGET LOCATION. AFTER APPROXIMATELY HALFWAY THROUGH THE PROCEDURE, THE PHYSICIAN NOTICED A RADIOPAQUE OBJECT UNDER FLUOROSCOPY. THEREFORE, THE CAT7D AND SEP7D WAS REMOVED. SUBSEQUENTLY, UPON INSPECTING DISTAL END OF THE SEP7D ON THE BACK TABLE, THE PHYSICIAN NOTICED THE WIRE DISTAL TO THE BULB OF THE SEP7D HAD FRACTURED. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THE FRACTURED WIRE DISTAL TO THE SEP7D BULB CAME IN CONTACT WITH THE STENT STRUTS FROM A PREVIOUSLY PLACED STENT IN THE CEPHALIC ARCH AND MIGRATED INTO THE PULMONARY ARTERY. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED WIRE OF THE SEP7D IN THE VESSEL. THE PHYSICIAN DETERMINED THE WIRE WAS SMALL ENOUGH AND BELIEVED THERE WAS NO RISK TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BALLOON CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO TH

  Patient problems: Foreign Body In Patient

  MAUDE report 20091687 ↗
• MalfunctionJan 6, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILIC VEIN GRAFT USING AN INDIGO SYSTEM SEPARATOR 7 (SEP7), AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE PASSES USING THE SEP7 AND CAT7. SUBSEQUENTLY, AFTER MAKING THE FINAL PASS, THE SEP7 WAS STUCK, AND THE PHYSICIAN NOTICED THE WIRE AT THE DISTAL BULB OF THE SEP7 HAD BROKEN OFF IN THE THROMBOSED FISTULA UNDER FLUOROSCOPY. THEREFORE, THE PHYSICIAN ATTEMPTED TO USE THE CAT7 TO ASPIRATE THE BROKE WIRE OF THE SEP7; HOWEVER, THE BROKEN WIRE WAS STUCK IN THE HEAVY THROMBUS AND COULD NOT BE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO LEAVE THE BROKEN WIRE AND BELIEVED THERE WAS NO RISK TO THE PATIENT. THE PROCEDURE HAD ENDED AT THIS POINT AND THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER FOR THE PATIENT TO RECEIVE DIALYSIS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117954 ↗
• MalfunctionJan 4, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT BRACHIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 7D (SEP7D), AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D), INDIGO SYSTEM SEPARATOR 7 (SEP7), AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE CAT7D AND SEP7D. WHILE MAKING THE SECOND PASS, THE PHYSICIAN KINKED THE PROXIMAL END OF THE CAT7D, BUT THE PHYSICIAN DECIDED TO CONTINUE TO USE THE KINKED CAT7D. NEXT, UPON COMPLETING THE THIRD PASS, THE PHYSICIAN WAS REMOVING THE SEP7D; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE WIRE AT THE DISTAL BULB OF THE SEP7D BROKE OFF WITHIN THE VESSEL. SUBSEQUENTLY, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE REMOVING THE CAT7D AND BROKE IT INTO TWO SEPARATE PIECES AT THE PROXIMAL END WHERE THE KINK HAD OCCURRED. THEREFORE, THE CAT7D WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PHYSICIAN DETERMINED IT WAS SAFE TO LEAVE THE BROKEN WIRE OF THE SEP7D IN THE VESSEL AND DECIDED TO PLACE A STENT TO COVER THE BROKEN WIRE INTO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED USING A NEW CAT7, LIGHTNING, AND A NEW SEP7. THERE WAS

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099682 ↗
• MalfunctionSep 23, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PORTAL VEIN USING AN INDIGO SYSTEM SEPARATOR 7 D (SEP7 D), A ROTATING HEMOSTASIS VALVE (RHV), AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY FOUR PASSES USING THE SEP7 D AND MOVED SEP7 D APPROXIMATELY TEN TIMES IN AND OUT OF THE CATHETER. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE BULB OF THE SEP7 D SHEARED OFF. IT WAS REPORTED THAT THE BULB WAS NOT VISIBLE IN THE PATIENT'S BODY, IN THE CANISTER OR IN THE RHV. THE PROCEDURE WAS COMPLETED USING A NEW SEP7 D. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473527 ↗
• MalfunctionSep 13, 2022Break; Migration; Break; Migration

  HOLD FOR MB 10.13 THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRACHIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 7 D (SEP7 D) AND AN INDIGO SYSTEM ASPIRATION CATHETER 7 D (CAT7 D). DURING THE PROCEDURE, AFTER COMPLETING THE FIRST PASS, THE PHYSICIAN REMOVED THE CAT7 D AND SEP7 D AND NOTICED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP7 D HAD MIGRATED FROM THE PATIENT''S ARM INTO THE LUNG. THE PROCEDURE ENDED AT THIS POINT AND NO FURTHER INTERVENTION WAS PERFORMED TO REMOVE THE FOREIGN BODY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414465 ↗