Indigo System LITNGFHT80BER-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948024861), received between Nov 9, 2023 and Apr 29, 2024 — classified as 2 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AND A NEURON SELECT CATHETER 6F (6F SELECT). THE PATIENT''S BASELINE HEMOGLOBIN WAS NOTED TO BE 11 G/DL BEFORE THE PROCEDURE AND DROPPED TO 5.1 G/DL POST PROCEDURE. THE PATIENT RECEIVED A TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS TO TREAT THE ANEMIA. IT WAS REPORTED THAT A CT SCAN OF THE PELVIS SHOWED NO SIGNS OF A GI BLEED. ANEMIA WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Anemia

  MAUDE report 19201572 ↗
• DeathApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE LEFT AND RIGHT PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NON-PENUMBRA CATHETER, A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA SHEATH AND A GUIDE WIRE. IT WAS REPORTED THAT THE PATIENT WAS IN CRITICAL STATUS PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED FOUR PASSES IN THE RIGHT AND LEFT LOBES OF THE LUNG. WHILE COMPLETING THE FIFTH PASS IN THE LEFT LOBE, THE PATIENT STARTED COUGHING BLOOD AND WAS SAT UP. A RAPID RESPONSE TEAM WAS CALLED TO RESUSCITATE AND STABILIZE THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. A PERFORATION IN THE LEFT LOBE WAS NOTED IN AN X-RAY POST PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE MEDICAL INTENSIVE CARE UNIT (MICU). LATER, THE PATIENT EXPIRED. IT WAS REPORTED THAT THE DEVICE PERFORMED AS INTENDED AND THAT AGGRESSIVE MANEUVERING AND THE FRAGILITY OF THE PATIENTS LUNGS MAY HAVE CONTRIBUTED TO THE PERFORATION.

  Patient problems: Perforation of Vessels

  MAUDE report 19028724 ↗
• DeathFeb 9, 2024Adverse 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 ANGLED PIGTAIL CATHETER, A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA SHEATH AND A NON-PENUMBRA GUIDEWIRE. THE PHYSICIAN USED THE INTERNAL JUGULAR VEIN TO GAIN ACCESS TO THE TARGET LOCATION. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AN ANGLED PIGTAIL CATHETER AND WIRE INTO THE MAIN PULMONARY ARTERY. THEN THE PHYSICIAN REMOVED THE ANGLED PIGTAIL CATHETER AND ATTEMPTED TO ADVANCE THE FLASH CATHETER INTO THE RIGHT PULMONARY ARTERY; HOWEVER, THE FLASH CATHETER WOULD NOT ADVANCE THROUGH THE HEART. THE PHYSICIAN THEN PLACED A 6F SELECT IN THE FLASH CATHETER OVER THE GUIDEWIRE. WHILE ADVANCING THE FLASH CATHETER AND THE 6F SELECT OVER THE GUIDEWIRE THROUGH THE HEART, THE FLASH CATHETER JUMPED FORWARD. ALTHOUGH NO ANGIOGRAPHY WAS TAKEN, IT WAS REPORTED THAT THE CHORDAE TENDINAE OF THE HEART MAY HAVE BEEN RUPTURED BY THE FLASH CATHETER. AT THIS POINT, THE PATIENT DECOMPENSATED AND BECAME UNRESPONSIVE. THE CODE TEAM WAS CALLED AND PERFORMED CPR ON THE PATIENT BUT WERE UNSUCCESSFUL AND THE PATIENT EXPIRED.

  Patient problems: Cardiac Perforation

  MAUDE report 18677675 ↗
• MalfunctionNov 9, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT LUNG USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES WITH THE FLASH CATHETER AND SHEATH. WHILE RETRACTING THE FLASH CATHETER FROM INFERIOR VENA CAVA (IVC), THE PHYSICIAN FRACTURED THE DISTAL PORTION OF FLASH CATHETER. THEREFORE, THE PROXIMAL PORTION OF THE FLASH CATHETER WAS REMOVED WITHIN THE SHEATH. THE PHYSICIAN ADVANCED A DIFFERENT NON-PENUMBRA SHEATH TO THE IVC AND USED A SNARE DEVICE TO REMOVE THE DISTAL PORTION OF THE FLASH CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107997 ↗