Indigo System CAT8XTORQ115KIT-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00815948022324), received between Jun 17, 2021 and May 15, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN A STENT PREVIOUSLY PLACED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. THE PHYSICIAN ADVANCED THE CAT8 THROUGH THE STENT AND INITIATED ASPIRATION. AFTER FOUR PASSES, WHILE RETRACTING THE CAT8, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MID-SECTION OF THE STENT. UNDER FLUOROSCOPY, THE MARKERBAND WAS OBSERVED TO HAVE BECOME DISLODGED AND REMAINED WITHIN THE STENT. A SNARE WAS ADVANCED THROUGH THE SHEATH, AND THE DETACHED MARKERBAND WAS SUCCESSFULLY RETRIEVED FROM THE STENT. THE PROCEDURE WAS COMPLETED USING A NEW CAT6 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 25192259 ↗
• MalfunctionSep 11, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT A THROMBOTIC OCCLUSION WAS OBSERVED IN THE PROXIMAL SEGMENT OF THE SFA AND THAT A STENT WAS PREVIOUSLY PLACED IN THE MIDDLE PORTION OF THE SFA. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE CAT8 AND SEP8 INTO THE SHEATH USING AN INTRODUCER AND ADVANCED THE CAT8 AND SEP8 TO THE PROXIMAL SEGMENT OF THE SFA. UNDER THE FLUOROSCOPY, THE PHYSICIAN THEN NOTICED THAT THE MARKERBAND WAS DEFORMED PRIOR TO INITIATING ASPIRATION. THEREFORE, THE CAT8 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE MARKERBAND WAS PEELING OFF BUT REMAINED INTACT WITH THE CAT8. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND A NEW SEP8, 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 23031196 ↗
• MalfunctionFeb 12, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN INDIGO SYSTEM SEPARATOR 8 (SEP8), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS REPORTED THAT A STENT WAS PREVIOUSLY PLACED IN THE SFA, AND THAT THROMBOTIC OCCLUSION WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE STENT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 AND SEP8 INTO THE IN-STENT OCCLUSION AND INITIATED ASPIRATION. WHILE ASPIRATING, THE PHYSICIAN NOTICED THAT THE STENT COLLAPSED. IT WAS REPORTED THAT THE DISTAL END OF THE CAT8 BECAME TRAPPED WITHIN THE STENT STRUTS AND BECAME DEFORMED. THEREFORE, THE CAT8 WAS REMOVED AND UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CAT8 WAS DAMAGED. UNDER FLUOROSCOPY, THE PHYSICIAN OBSERVED THAT THE MARKERBAND OF THE CAT8 WAS IN THE SFA, DISTAL TO THE STENT. THE PHYSICIAN USED BIOPSY FORCEPS VIA THE ENDOVASCULAR APPROACH TO SUCCESSFULLY REMOVE THE DETACHED MARKERBAND FROM THE SFA. THE PROCEDURE WAS COMPLETED USING A NEW CAT8, A NEW SEP8, AND THE SAME SHEATH. IT SHOULD BE NOTED THAT THERE WAS NO NOTED DAMAGE TO THE FIRST SEP8. THERE WAS NO REPORT OF AN ADVERSE EFFECT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367521 ↗
• MalfunctionNov 15, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INTRODUCING THE CAT8 INTO THE TARGET VESSEL. IT WAS REPORTED THAT THERE WAS AN ISSUE WHILE ATTEMPTING TO ASPIRATE WITH THE CAT8. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE CAT8. UPON REMOVAL OF THE CAT8, THE PHYSICIAN FOUND THAT THE CAT8 WAS FRACTURED AT THE DISTAL LENGTH. THEREFORE, THE SHEATH AND THE REMAINING FRAGMENT OF THE CAT8 WERE REMOVED FROM THE PATIENT TOGETHER. THE PROCEDURE WAS ENDED AT THIS POINT AND THE PHYSICIAN PLANS TO CONTINUE THE PROCEDURE AT A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700726 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN INDIGO SYSTEM SEPARATOR 8 (SEP8), A NON-PENUMBRA SHEATH (8F) AND A .035 GUIDEWIRE. IT WAS REPORTED THAT A NON-PENUMBRA STENT WAS PREVIOUSLY PLACED IN THE SFA, AND THAT THROMBOTIC OCCLUSION WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE STENT. DURING THE PROCEDURE, THE CAT8 AND SEP8 WERE ADVANCED THROUGH THE SHEATH AND INTO THE STENT AND ASPIRATION WAS INITIATED. THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT8 AND SEP8 AND NOTICED THAT THE MARKERBAND ON THE DISTAL END OF THE CAT8 CAME OFF. THEREFORE, THE CAT8 AND SEP8 WERE REMOVED. IT WAS REPORTED THAT WHILE ASPIRATING, THE STENT WOULD TEMPORARILY DEFORM DUE TO THE ASPIRATION FORCE BUT RETURNED TO NORMAL WHEN THE ASPIRATION STOPPED. THE PHYSICIAN THEN ADVANCED A NEW CAT8 AND SEP8 INTO THE STENT USING THE SAME SHEATH AND INITIATED ASPIRATION TO REMOVE THE DETACHED MARKERBAND AND THROMBUS. AFTER COMPLETING ONE PASS, THE PHYSICIAN NOTICED THAT THE MARKERBAND ON THE DISTAL END OF THE SECOND CAT8 CAME OFF AS WELL. THEREFORE, THE CAT8 AND SEP8 WERE REMOVED. THE PHYSICIAN THEN DECIDED TO PERFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066235 ↗
• MalfunctionAug 23, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHORT SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 INTO THE TARGET VESSEL AND SUCCESSFULLY COMPLETED ONE PASS. WHILE REMOVING THE CAT8, THE PHYSICIAN EXPERIENCED RESISTANCE AND UPON REMOVAL, THE PHYSICIAN FOUND THAT THE DISTAL END OF THE CAT8 HAD FRACTURED OFF. THEREFORE, THE CAT8 WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057681 ↗
• MalfunctionAug 13, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE CAT8. WHILE PERFORMING A CONTRAST INJECTION USING THE CAT8, THE CAT8 BECAME FRACTURED IN TWO LOCATIONS AT THE PROXIMAL END NEAR THE HUB, OUTSIDE THE PATIENT. THEREFORE, THE CAT8 WAS REMOVED AND THE FRACTURED PART OF THE CAT8 WAS REMOVED FROM THE PATIENT TOGETHER WITH THE SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 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 19977194 ↗
• MalfunctionMar 24, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIOPERONEAL TRUNK (TPT) AND DISTAL POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT8. SUBSEQUENTLY, WHILE TORQUING THE CAT8 AFTER ASPIRATING THE CLOT, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE CAT8 WAS NOT MOVING AND HAD BROKEN IN HALF. THEREFORE, THE CAT8 WAS REMOVED ALONG WITH THE SHEATH. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616297 ↗
• MalfunctionAug 2, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INSERTING THE CAT8 INTO THE SHEATH, THE PHYSICIAN KINKED THE DISTAL TIP OF THE CAT8. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12263221 ↗
• InjuryJun 17, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT HAD A STEEP ILIAC BIFURCATION. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT8 AND THE SHEATH. THE PHYSICIAN THEN PLACED MULTIPLE STENTS FROM THE POPLITEAL ARTERY TO THE SFA. WHILE ADVANCING THE CAT8 THROUGH THE STENTS FOR THE SECOND PASS, THE CAT8 BECAME STUCK ON A STENT STRUT. SUBSEQUENTLY, THE PHYSICIAN TORQUED THE CAT8, AND THE CAT8 BROKE INTO TWO PIECES. THEREFORE, THE PHYSICIAN REMOVED PART OF THE CAT8 AND THE SHEATH. NEXT, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN DISTAL END OF THE CAT8 USING TWO SNARE DEVICES; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO USE A BALLOON CATHETER TO PUSH THE BROKEN PIECE OF THE CAT8 INTO THE AORTA TO GRAB IT; HOWEVER, IT WAS ALSO UNSUCCESSFUL. THEREFORE, AN OPEN SURGERY VIA CUTDOWN TECHNIQUE WAS PERFORMED TO REMOVE THE BROKEN PIECE OF THE CAT8. THE PROCEDURE ENDED AFTER THE SURGERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016843 ↗