Indigo System LITNGFHT115BER-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00815948024892), received between Apr 14, 2023 and Jul 8, 2024 — classified as 4 deaths, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)( 6) 2024, THE PATIENT UNDERWENT A BILATERAL PULMONARY THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), DIAGNOSTIC CATHETERS (6FR, JR4 AND 7FR GPC), A PULMONARY WEDGE CATHETER (7FR X 110CM SWANZ-GANZ), GUIDEWIRES (SUPER STIFF AMPLATZ, J-WIRE, AND SUPRACORE 0.35), AND SHEATHS (5FR X 10CM, 7FR X 10CM, AND 16FR DRYSEAL) VIA THE RIGHT COMMON FEMORAL VEIN. DURING THE PROCEDURE, THE 5FR SHEATH WAS EXCHANGED FOR A 7FR SHEATH. THE FEMORAL VENOUS SITE WAS THEN SERIALLY DILATED, AND THE SHEATH WAS UPSIZED TO A 16FR. NEXT, THE PULMONARY WEDGE CATHETER WAS ADVANCED UNDER FLUOROSCOPY INTO THE RIGHT PULMONARY ARTERY. A RIGHT HEART CATHETERIZATION WAS PERFORMED. THE PULMONARY ARTERY PRESSURE WAS NOTED TO BE 41/13/25 MMHG. SATURATIONS WERE DRAWN AND THE CARDIAC INDEX WAS FOUND TO BE 1.4 L/MIN WITH A MIXED VENOUS SATURATION OF 40%, WHICH SHOWED SIGNIFICANT EVIDENCE OF RIGHT VENTRICULAR DYSFUNCTION. THE PULMONARY WEDGE CATHETER WAS EXCHANGED FOR A 7FR DIAGNOSTIC CATHETER, AND A GUIDEWIRE WAS ADVANCED INTO THE LEFT PULMONARY ARTERY. THE DIAGNOSTIC CATHETER WAS REMOVED, AND THE FLASH CATHETER WAS ADVANCED INTO THE LEFT PULMONARY ARTERY. SEVERAL PASSES WER

  Patient problems: Cardiac Arrest

  MAUDE report 19697447 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT INTERLOBAR SEGMENT, RIGHT MIDDLE LOBE, AND RIGHT LOWER LOBE USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER) AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE FLASH CATHETER AND SHEATH DUE TO THE TORTUOSITY OF THE PULMONARY ARTERY WITH AN ACUTE ANGLE COMING FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). AFTER COMPLETION OF THE PROCEDURE, WHILE REMOVING THE ASPIRATION CATHETER, THE PATIENT STARTED TO EXPERIENCE NAUSEA AND LOST CONSCIOUSNESS AND BEGAN EXPERIENCING PULMONARY EMBOLISM (PE) CARDIAC ARREST. THE PHYSICIAN PERFORMED CARDIOPULMONARY RESUSCITATION (CPR) AND CARDIAC ANESTHESIA. IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY (CT) SURGERY AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TEAM WERE CALLED IN. THE PHYSICIAN THEN DECIDED TO PERFORM AN OPEN SURGERY REPAIR FOR CONCERNS OF A RIGHT VENTRICULAR (RV) PERFORATION AND CARDIAC TAMPONADE. THE CT SURGERY TEAM PERFORMED AN URGENT STERNOTOMY AND NOTED AN INJURY TO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). IT WAS ALSO REPORTED THAT AN INJURY WAS SEEN IN THE RIGHT VENTRICLE (RV) WHICH W

  Patient problems: Cardiac Perforation

  MAUDE report 18548427 ↗
• MalfunctionDec 4, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM ASPIRATION FLASH CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE FLASH CATHETER. THE PHYSICIAN THEN TORQUED THE FLASH CATHETER THROUGH THE SHEATH AND NOTICED THAT THE FLASH CATHETER WAS STUCK WITHIN THE SHEATH. IT WAS REPORTED THAT THE FLASH CATHETER APPEARED TO BE FRACTURED AT THE MIDSHAFT UNDER FLUOROSCOPY. THE FLASH CATHETER AND THE SHEATH WERE REMOVED TOGETHER AND WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW FLASH CATHETER, THE SAME FLASH TUBING, AND A NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256526 ↗
• MalfunctionNov 22, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT PULMONARY ARTERIES USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), A NEURON SELECT CATHETER 6F (6F SELECT), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FLASH CATHETER TO THE TARGET LOCATION AND COMPLETED SEVERAL PASSES. WHILE TORQUING THE FLASH CATHETER, THE DISTAL PORTION OF THE FLASH CATHETER FRACTURED IN THE RIGHT PULMONARY ARTERY. THE PHYSICIAN WAS ABLE TO ADVANCE A GUIDEWIRE THROUGH THE FLASH CATHETER AND RETRACT THE FRACTURED FLASH CATHETER THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW FLASH CATHETER, THE SAME 6F SELECT, THE SAME SEP12, 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 18195247 ↗
• MalfunctionNov 17, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON ILIAC VEIN (CIV) USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT HAD AN EXISTING STENT IN THE CIV. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY TWO PASSES USING THE FLASH CATHETER. WHILE TORQUING THE FLASH CATHETER THROUGH THE STENT, THE PHYSICIAN EXPERIENCED RESISTANCE. THE FLASH CATHETER WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT MATERIAL NEAR THE DISTAL TIP WAS DAMAGED ON THE FLASH CATHETER. IT WAS REPORTED THAT UPON FLUSHING, MATERIAL WAS MIXED IN WITH THE CLOT THAT WAS BELIEVED TO BE PART OF THE FLASH CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER FLASH CATHETER, ANOTHER FLASH TUBING, THE SAME SHEATH, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166296 ↗
• DeathAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PULMONARY ARTERY (LPA) USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER) AND AN INDIGO SYSTEM SEPARATOR 12 (B)(6). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES. WHILE ADVANCING THE FLASH CATHETER TO COMPLETE ANOTHER PASS, THE PATIENT STARTED COUGHING BLOOD AND THE PHYSICIAN NOTICED A PERFORATION OF THE LPA. THE PHYSICIAN TREATED THE PERFORATION WITH A BALLOON TAMPONADE. IT WAS REPORTED THE PATIENT LATER EXPIRED. THE CAUSE OF DEATH WAS LEFT MAIN PULMONARY ARTERY PERFORATION.

  Patient problems: Great Vessel Perforation

  MAUDE report 17627872 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), NEURON SELECT CATHETER 6F (6F SELECT), NON-PENUMBRA BALLOON CATHETER, NON-PENUMBRA SHEATHS, AND GUIDEWIRES. IT WAS REPORTED THAT THE PATIENT RECEIVED 9,000 UNITS OF HEPARIN. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE RIGHT COMMON FEMORAL ARTERY USING AN 8F SHEATH. THE PHYSICIAN USED MULTIPLE GUIDEWIRES, SHEATHS AND CATHETERS TO ACCESS THE TARGET VESSEL. A FLASH CATHETER WAS ADVANCED INTO THE PROXIMAL PORTION OF THE LEFT PULMONARY ARTERY. THE FLASH TUBING WAS POWERED ON WITH A NON-AUDIBLE YELLOW LIGHT ILLUMINATING. THE PHYSICIAN ATTEMPTED TO SLIGHTLY MOVE THE FLASH CATHETER TO THE PATENT AREA BUT DECIDED TO RETRACT THE FLASH CATHETER BACK INTO THE SHEATH. AFTER RETRACTING THE FLASH CATHETER HALFWAY OUT OF THE SHEATH, A PIECE OF THROMBUS WAS ASPIRATED THROUGH THE TUBING. THE FLASH CATHETER WAS REMOVED FROM THE PATIENT AND WAS FLUSHED. IT WAS ALSO REPORTED THAT THERE WAS THROMBUS IN THE SHEATH AS WELL. THE FLASH CATHETER WAS ADVANCED WITH ASPIRATION INTO THE SHEATH AND REMOVE

  Patient problems: Cardiac Tamponade

  MAUDE report 17431200 ↗
• MalfunctionJul 5, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY USED THE FLASH CATHETER TO REMOVE CLOT IN THE TARGET VESSEL. AFTER COMPLETING ANOTHER PASS IN A DIFFERENT BRANCH OF THE PULMONARY ARTERY, THE PHYSICIAN WAS TORQUEING THE FLASH CATHETER AND NOTICED THAT IT APPEARED FRACTURED UNDER FLUOROSCOPY. THE FLASH CATHETER WAS ABLE TO BE RETRACTED AND REMOVED INTACT. WHILE HANDLING THE FLASH CATHETER AFTER REMOVAL FROM THE PATIENT, THE PHYSICIAN INADVERTENTLY KINKED THE FLASH CATHETER IN MULTIPLE LOCATIONS BELOW THE FRACTURE. THE PROCEDURE WAS SUCCESSFULLY 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 17261311 ↗
• DeathJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FLASH CATHETER THROUGH THE SHEATH INTO THE RIGHT VENTRICLE OVER THE GUIDEWIRE THAT WAS IN THE RIGHT PULMONARY ARTERY. IT WAS REPORTED THAT WHILE ADVANCING THE FLASH CATHETER, THE GUIDEWIRE KICKED BACK. AT THIS POINT, THE PHYSICIAN DETERMINED THAT MORE SUPPORT WAS NEEDED. THEREFORE, THE FLASH CATHETER WAS REMOVED, AND A LONGER NON-PENUMBRA GUIDE SHEATH WAS INTRODUCED. THE PHYSICIAN THEN ADVANCED THE FLASH CATHETER OVER THE GUIDEWIRE INTO THE RIGHT VENTRICLE THROUGH THE SECOND NON-PENUMBRA GUIDE SHEATH. RESISTANCE WAS AGAIN ENCOUNTERED FROM LACK OF SUPPORT AND THE GUIDEWIRE KICKED BACK. THE PHYSICIAN NOTICED THE PATIENT''S VITALS DECREASED. THEREFORE, THE FLASH CATHETER AND ALL OTHER DEVICES WERE REMOVED. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED AND IDENTIFIED FLUID NEAR THE HEART (CARDIAC TAMPONADE). IT WAS REPORTED THAT THE PATIENT EXPIRED. THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE FLASH CATHETER IS UNKNOWN.

  Patient problems: Cardiac Tamponade

  MAUDE report 17228757 ↗
• DeathApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NON-PENUMBRA SHEATH, NON-PENUMBRA DIAGNOSTIC CATHETERS AND GUIDEWIRES. DURING THE PROCEDURE, THE PATIENT EXPERIENCED HEMOPTYSIS WHILE USING THE FLASH CATHETER. THE FLASH CATHETER WAS THEN REMOVED AND THE PATIENT CODED. IT WAS REPORTED THAT THE PATIENT THEN EXPIRED.

  Patient problems: Hemoptysis

  MAUDE report 16815110 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY (RPA) AND THE LEFT PULMONARY ARTERY (LPA) USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FLASH CATHETER WAS TIGHT IN THE SHEATH. THE PHYSICIAN SUCCESSFULLY REMOVED THROMBUS FROM BOTH THE TARGET LOCATIONS. WHILE REMOVING THE FLASH CATHETER, THE PHYSICIAN LUBRICATED THE PROXIMAL END OF THE FLASH CATHETER AND THE SHEATH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ROTATE THE FLASH CATHETER IN THE SHEATH TO HELP REMOVE THE FLASH CATHETER; HOWEVER, WHILE DOING THIS, THE PHYSICIAN LOST CONTROL OF THE SHEATH AND THE SHEATH ADVANCED 2-3 CM FORWARD CAUSING A SMALL PERFORATION IN THE RIGHT UPPER LOBE. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT HAD A BRIEF PERIOD OF HEMOPTYSIS WHICH RESOLVED ON ITS OWN. IT WAS REPORTED THAT THE PATIENT''S VITALS AND OXYGEN SATURATION IMPROVED DRASTICALLY AFTER THE PROCEDURE.

  Patient problems: Hemoptysis; Perforation

  MAUDE report 16744742 ↗