Indigo System LITNG8XTORQ115-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815948023291), received between Jun 4, 2021 and Nov 12, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT ILIAC, FEMORAL, AND POPLITEAL VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, AFTER MAKING SEVERAL PASSES USING THE LIGHTNING AND CAT8 TO TREAT A DEEP VEIN THROMBOSIS (DVT), THE PHYSICIAN NOTICED THERE WAS NO FLOW THROUGH THE CAT8 AND THE DISTAL END OF THE CAT8 HAD KINKED UNDER X-RAY. THEREFORE, THE CAT8 WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO REMOVE THE SHEATH AND SWITCH TO A LARGER SIZED SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW SHEATH AND AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12) WITH THE SAME LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807673 ↗
• MalfunctionOct 13, 2021Misconnection; Connection Problem; Misconnection; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT PULMONARY EMBOLISM USING THE LIGHTNING ASPIRATION TUBING (LIGHTNING) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE ROTATING HEMOSTASIS VALVE (RHV) WAS UNSCREWED AND WOULD NOT SCREW BACK. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV WITH THE SAME CAT12 AND LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627589 ↗
• MalfunctionOct 12, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT ILIAC AND FEMORAL VEINS USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES USING THE CAT8. WHILE ADVANCING THE CAT8 THROUGH THE SHEATH AND PERFORMING A CORING TECHNIQUE, THE PHYSICIAN KINKED THE DISTAL TIP OF THE CAT8 AT THE LEVEL OF DEFLECTION. IT WAS REPORTED THAT THE DISTAL TIP OF THE CAT8 KEPT FOLDING ON ITSELF WHEN BEING ADVANCED THROUGH THE SHEATH. THEREFORE, THE CAT8 WAS REMOVED. 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 12617369 ↗
• MalfunctionOct 11, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN INTRODUCER AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE TRYING TO ADVANCE THE INTRODUCER AND THE CAT8 THROUGH THE SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THEM. THE PHYSICIAN THEN ATTEMPTED TO USE TWO GUIDEWIRES TO HELP ADVANCE THE CAT8 THROUGH THE SHEATH; HOWEVER, WHILE ATTEMPTING TO ADVANCE, THE DISTAL END OF THE CAT8 KINKED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8, A NEW INTRODUCER AND A NEW SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12609266 ↗
• MalfunctionSep 29, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT12 PROXIMAL TO THE CLOT IN THE TARGET VESSEL, WHEN THE PHYSICIAN PLUGGED THE LIGHTNING UNIT INTO THE USB PORT ON THE BACK OF THE ENGINE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT BRIEFLY POWERED ON WITH THE GREEN INDICATOR LIGHT AND THEN TURNED OFF. THE ENGINE WOULD POWER ON WITH ALL FOUR INDICATOR LIGHTS ILLUMINATED; HOWEVER, THERE WAS NO ASPIRATION AT THE TIP OF THE CAT12 OR THE TUBING. IT WAS ALSO REPORTED THAT WHEN THE HOSPITAL STAFF REMOVED THE LIGHTNING FROM THE CANISTER, THE CANISTER WAS ABLE TO BUILD PRESSURE. THE HOSPITAL STAFF ALSO MADE MULTIPLE ATTEMPTS TO DISCONNECT AND RECONNECT THE LIGHTNING UNIT INTO THE USB PORT ON THE ENGINE TO TROUBLESHOOT; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE LIGHTNING WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO USE TWO NEW LIGHTNINGS WITH A NEW CAT12, A NEW CAT8, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550948 ↗
• MalfunctionJul 6, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE BACK HUB TWISTED OFF THE CAT8 AS IT WAS BEING TORQUED IN THE TARGET VESSEL. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125250 ↗
• MalfunctionJun 4, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL AND ILIAC VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE CAT8 WAS ADVANCED TO THE TARGET LOCATION WITH THE INDICATOR LIGHT ON THE LIGHTING UNIT ILLUMINATING GREEN. WHEN THE PHYSICIAN TURNED THE SWITCH FOR THE LIGHTNING UNIT INTO THE ON POSITION, THE INDICATOR LIGHT IMMEDIATELY TURNED SOLID RED AND THERE WAS NO ASPIRATION. SUBSEQUENTLY, THE PHYSICIAN UNPLUGGED THE LIGHTNING UNIT TO RESET AND CHECK TO SEE IF THE CANISTER WAS CORRECTLY SEALED TO TROUBLESHOOT; HOWEVER, THE LIGHTNING UNIT REMAINED SOLID RED. THEREFORE, THE LIGHTNING AND CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) WITH THE SAME CANISTER. ADDITIONALLY, THE PHYSICIAN PERFORMED ANGIOPLASTY AND PLACED A NON-PENUMBRA CATHETER FOR FURTHER TREATMENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942610 ↗