Indigo System SEP5-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00814548016108), received between Feb 24, 2016 and Apr 6, 2021 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) FISTULA IN THE RIGHT ARM USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5), AN INDIGO SYSTEM SEPARATOR 5 (SEP5), A 5F SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE FISTULA WITH THE SHEATH AND ADVANCED THE CAT5 OVER THE GUIDEWIRE AND PAST THE THROMBUS. SUBSEQUENTLY, THE PHYSICIAN PULLED THE CAT5 BACK INTO THE CLOT AND DECIDED TO USE THE SEP5. HOWEVER, THE SEP5 WOULD NOT ADVANCE TO THE END OF THE CAT5. THEREFORE, THE WHOLE SYSTEM WAS REMOVED, AND IT WAS FOUND THAT THE DISTAL END OF THE CAT5 WAS BENT AND KINKED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623617 ↗
• MalfunctionSep 9, 2020Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY AND ANTERIOR TIBIAL ARTERY USING INDIGO SYSTEM CAT5 ASPIRATION CATHETERS (CAT5S), INDIGO SYSTEM SEPARATORS 5 (SEP5S), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A CAT5 OVER THE GUIDEWIRE THROUGH THE SHEATH AND INTO THE LEFT PERONEAL ARTERY ANTEGRADE. THE SEP5 WAS THEN ADVANCED AND THE PHYSICIAN WORKED HIS WAY DOWN USING THE SEP5 AND THERE WAS SLOW BUT CONSTANT FLOW MOST OF THE TIME. TWO PASSES WERE COMPLETED USING THE CAT5 AND SEP5. THE PHYSICIAN THEN CAME TO A CURVE IN THE TARGET ARTERY AND THE LUMEN OF THE VESSEL SEEMED SIGNIFICANT NARROWER AND EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE SEP5 OUT OF THE TIP OF THE CAT5. SUBSEQUENTLY, NO PROGRESS WAS OBSERVED WITH THE THROMBUS ASPIRATION; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SEP5 AND CAT5. UPON REMOVAL, IT WAS NOTICED THAT ONE FIFTH OF THE DISTAL END OF THE CAT5 WAS OVALIZED AND THE SEP5 WAS KINKED AT MULTIPLE POINTS. IT WAS REPORTED THAT THE SEP5 WAS PULLED THROUGH ITS INTRODUCER SHEATH ON THE TABLE TO SEE IF THE SEP5 WOULD GO THROUGH OR STRAIGHTEN; HOWEVER, THE SEP5 BROKE INSIDE THE INTRODUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508491 ↗
• InjurySep 9, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY AND ANTERIOR TIBIAL ARTERY USING INDIGO SYSTEM CAT5 ASPIRATION CATHETERS (CAT5S), INDIGO SYSTEM SEPARATORS 5 (SEP5S), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A CAT5 OVER THE GUIDEWIRE THROUGH THE SHEATH AND INTO THE LEFT PERONEAL ARTERY ANTEGRADE. THE SEP5 WAS THEN ADVANCED AND THE PHYSICIAN WORKED HIS WAY DOWN USING THE SEP5 AND THERE WAS SLOW BUT CONSTANT FLOW MOST OF THE TIME. TWO PASSES WERE COMPLETED USING THE CAT5 AND SEP5. THE PHYSICIAN THEN CAME TO A CURVE IN THE TARGET ARTERY AND THE LUMEN OF THE VESSEL SEEMED SIGNIFICANT NARROWER AND EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE SEP5 OUT OF THE TIP OF THE CAT5. SUBSEQUENTLY, NO PROGRESS WAS OBSERVED WITH THE THROMBUS ASPIRATION; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SEP5 AND CAT5. UPON REMOVAL, IT WAS NOTICED THAT ONE FIFTH OF THE DISTAL END OF THE CAT5 WAS OVALIZED AND THE SEP5 WAS KINKED AT MULTIPLE POINTS. IT WAS REPORTED THAT THE SEP5 WAS PULLED THROUGH ITS INTRODUCER SHEATH ON THE TABLE TO SEE IF THE SEP5 WOULD GO THROUGH OR STRAIGHTEN; HOWEVER, THE SEP5 BROKE INSIDE THE INTRODUC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508469 ↗
• MalfunctionJul 25, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SEP5 THROUGH AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). AS THE PHYSICIAN ATTEMPTED TO RETRACT THE SEP5 THROUGH THE CAT5, RESISTANCE WAS ENCOUNTERED. IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE TIP WITH THE "OLIVE" DID NOT MOVE. AS THE PHYSICIAN CONTINUED TO RETRACT SMOOTHLY, THE SEP5 WAS SUCCESSFULLY REMOVED; HOWEVER, IT WAS FOUND THAT THE WIRE ON THE SEP5 WAS COMPLETELY DAMAGED, LENGTHENED, AND DESTROYED. THE TIP WITH THE "OLIVE" WAS STILL ON THE WIRE AND NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO MENTION OF ANY DAMAGE TO THE CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828623 ↗
• InjuryJun 28, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PROFUNDA FEMORIS ARTERY USING AN INDIGO SYSTEM SEPARATOR 5 (SEP5). IT WAS NOTED AFTER A SUCCESSFUL TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A BALLOON CATHETER THE CLOT SHIFTED TO THE PROFUNDA FEMORIS ARTERY. DURING THE PROCEDURE, AFTER MAKING SEVERAL SUCCESSFUL PASSES USING THE SEP5 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) AND A NON-PENUMBRA SHEATH, THE PHYSICIAN NOTICED THE TIP OF THE SEP5 HAD BROKEN OFF WITHIN THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE SEP5. THE PHYSICIAN THEN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE BROKEN TIP OF THE SEP5 AND DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745277 ↗
• MalfunctionMay 1, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL AND COMMON ILIAC ARTERIES USING AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, A CLOT BEGAN TO BUILD UP IN THE INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND THE PHYSICIAN DECIDED TO REMOVE THE CAT5 AND SEP5 TOGETHER. THE CAT5 WAS THEN FLUSHED AND RE-ADVANCED INTO THE PATIENT. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SEP5 INTO THE CAT5 THROUGH THE TUOHY VALVE AND REPORTED THAT THE TIP OF THE SEP5 BECAME KINKED AT THE DISTAL PORT OF THE TUOHY VALVE. IT WAS THEN DISCOVERED THAT THE DISTAL PORT OF THE TUOHY VALVE HAD BEEN ACCIDENTALLY LEFT CLOSED. THE SEP5 WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SEP5 AND THE SAME CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8568584 ↗
• MalfunctionApr 2, 2018Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE SEP5 WITHIN AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). UPON REMOVAL OF THE SEP5, THE PHYSICIAN NOTICED THAT THE TIP OF THE SEP5 HAD BECOME PARTIALLY UNRAVELED. THE PROCEDURE WAS THEN CONTINUED USING A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389497 ↗
• MalfunctionDec 28, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN A POPLITEAL VEIN USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, WHILE USING THE SEP5 WITHIN THE CAT5, THE SEP5 PERFORATED THROUGH THE SIDE OF THE CAT5. IT WAS REPORTED THAT THIS WAS A CHRONIC CLOT, AND THOUGH THE PHYSICIAN FELT RESISTANCE WHILE USING THE SEP5 WITHIN THE VESSEL, THERE WAS NO RESISTANCE WHILE ADVANCING WITHIN THE CAT5. THE PHYSICIAN THEREFORE REMOVED THE CAT5 AND SEP5, AND ATTEMPTED TO USE A NON-PENUMBRA CATHETER TO REMOVE THE THROMBUS, HOWEVER WAS STILL UNSUCCESSFUL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7151723 ↗
• MalfunctionNov 17, 2017Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTLY CRUSHED THE DISTAL TIP OF THE CAT5 UPON INSERTION INTO THE NON-PENUMBRA SHEATH AND THEREFORE, THE CAT5 WAS REMOVED. A NEW CAT5 WAS THEN INSERTED, AND THE PHYSICIAN CONTINUED THE PROCEDURE USING A SEP5 WITHIN THE CAT5. WHILE IN USE, THE BULB OF THE SEP5 BECAME BROKEN WHILE IN USE INSIDE THE PATIENT, HOWEVER THE BULB DID NOT FULLY DETACH FROM THE PUSHER WIRE. THE PHYSICIAN THEREFORE WAS ABLE TO REMOVE THE SEP5 AND THE BULB BY SIMPLY RETRACTING THE SEP5. THE PROCEDURE WAS THEN COMPLETED USING THE SAME 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 7042966 ↗
• MalfunctionMay 9, 2017Stretched; Physical Resistance; Difficult to Advance; Stretched; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRANCHIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF THE SEP5 WAS NOT MOVING IN CONJUNCTION WITH PROXIMAL END OF THE SEP5 WITHIN THE INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5); THEREFORE THE CAT5 WAS REMOVED WITH THE SEP5 INSIDE. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE DISTAL TIP OF THE SEP5 WAS STRETCHED AND UNUSABLE. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW SEP5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556026 ↗
• MalfunctionFeb 17, 2017Stretched; Device Damaged by Another Device; Mechanical Jam; Stretched; Device Damaged by Another Device; Mechanical Jam

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OF THE LEFT LEG USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT5 WITH THE SEP5 INSIDE FOR THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE DISTAL TIP OF THE CAT5 BECAME KINKED. THEREFORE, THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRACT THE SEP5 AND DECIDED TO REMOVE THE ENTIRE SYSTEM AND END THE PROCEDURE AT THAT POINT. UPON REMOVAL OF SEP5 FROM THE CAT5, IT WAS OBSERVED THAT THE SEP5 WAS STRETCHED DUE TO THE KINKED CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6341147 ↗
• MalfunctionJul 9, 2016Break; Detachment Of Device Component; Material Separation; Break; Detachment Of Device Component; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, WHILE USING THE CAT6, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THERE WAS NO ASPIRATION. THEREFORE, THE CAT6 WAS REMOVED FROM THE PATIENT. UPON REMOVAL OF THE CAT6, THE PHYSICIAN NOTICED THAT IT HAD COLLAPSED. THE PROCEDURE CONTINUED USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) AND A SEP5. UPON COMPLETING THE PROCEDURE USING THE CAT5 AND THE SEP5, THE PHYSICIAN WENT TO REMOVE THE SEP5 AND NOTICED THAT THE BULB OF THE SEP5 HAD SEPARATED FROM THE WIRE AND WAS LEFT IN THE CAT5. THEREFORE, THE PHYSICIAN SAFELY ASPIRATED THE SEP5 BULB OUT OF THE CAT5 AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5780658 ↗
• MalfunctionMay 31, 2016Break; Device Operates Differently Than Expected; Material Integrity Problem; Break; Device Operates Differently Than Expected; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) DEVICES AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN OPENED AN INITIAL CAT6 AND NOTICED THAT IT WAS KINKED AT THE DISTAL TIP. THE KINKED CAT6 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE AND DID NOT ENTER THE PATIENT'S BODY. THE PHYSICIAN THEN OPENED A NEW CAT6 FOR THE PROCEDURE AND INSERTED IT INTO THE OTHER MANUFACTURER'S SHEATH. ON THE SECOND PASS, THE PHYSICIAN NOTICED THAT THE CAT6 WAS KINKED. THE PHYSICIAN DID NOT REPORT ANY RESISTANCE WHILE USING THE CAT6; HOWEVER, FORCE MAY HAVE BEEN APPLIED UPON INSERTION OF THE CAT6. THE KINKED CAT6 WAS REMOVED AND THE PROCEDURE CONTINUED USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) AND THE SEP5. WHILE USING THE CAT5 WITH THE SEP5, THE PHYSICIAN NOTICED THAT THE SEP5 WAS NOT EXITING THE CAT5 PROPERLY. UPON PULLING BACK THE CAT5 WITH FORCE, THE SEP5 CAME APART IN THE ROTATING HEMOSTASIS VALVE (RHV). THE BROKEN SEP5 WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW SEP5 AND THE SAME CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5690183 ↗
• MalfunctionMay 26, 2016Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A CLOTTED FEMORAL TO ANTERIOR TIBIAL BYPASS GRAFT USING AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, WHILE USING THE SEP5 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5), THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SEP5 BULB WAS NOT MOVING WITH THE REST OF THE DEVICE AS HE WAS ADVANCING AND RETRACTING THE SEP5 PUSHER WIRE. THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE WHILE USING THE SEP5 THROUGH THE CAT5. THE SEP5 WAS THEN REMOVED FROM THE PATIENT AND UPON VISUAL INSPECTION, THE PHYSICIAN CONFIRMED THAT THE SEP5 BULB WAS INTACT WITH THE SEP5 AND THAT NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE CONTINUED WITHOUT THE NEED FOR AN ADDITIONAL SEP5 AND WAS COMPLETED USING THE SAME CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5681763 ↗
• InjuryApr 6, 2016Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  CORRECTION: IN THE SECOND SENTENCE A CORRECTION WAS MADE FROM "PROXIMAL END" TO DISTAL END. THE CORRECTED SENTENCE READS AS FOLLOWS: DURING THE PROCEDURE, WHILE REMOVING THROMBUS, THE DISTAL END OF THE SEP5 FRACTURED IN THE PATIENT AND THE CAT5 BECAME KINKED.

  Patient problems: No Information

  MAUDE report 5552857 ↗
• MalfunctionFeb 24, 2016Stretched; Material Deformation; Stretched; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SEP5 THROUGH AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) AND STARTED TO REMOVE THROMBUS. AFTER 5-10 SECONDS OF PUSHING AND PULLING THROUGH THE CAT5, THE SEP5 BECAME STRETCHED AT THE HUB AND WAS REMOVED. ALTHOUGH THE SEP5 WAS STRETCHED, THERE WAS NO ISSUE REPORTED WITH THE CAT5 DEVICE. HOWEVER, THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE WITH ANOTHER MANUFACTURER'S ASPIRATION DEVICES. IT WAS LATER REPORTED THAT THE PROCEDURE WAS NOT SUCCESSFUL AND THE PATIENT'S LEG WAS STILL THROMBOSED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5458586 ↗