Indigo System LITNG12HTORQ115Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815948022928), received between Dec 18, 2023 and Nov 26, 2025 — classified as 1 death, 5 injuries.

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

• InjuryNov 26, 2025Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT LUNGS USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE CAT12 USING THE CATHETER, THE PHYSICIAN EXPERIENCED DIFFICULTY AND WHILE INTRODUCING THE CAT12 THROUGH THE RIGHT VENTRICLE TO THE PULMONARY ARTERIES. AT THAT TIME, THE PATIENT DECOMPENSATED, PRESENTING WITH BRADYCARDIA, HYPOTENSION, FOLLOWED BY A PAUSE IN THE CARDIAC RHYTHM. THE PHYSICIAN THEN ADMINISTERED MEDICATION (ATROPINE AND DOBUTAMINE). NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. ON (B)(6) 2025, THE EVENT WAS CONSIDERED RESOLVED. THE DECOMPENSATION WITH BRADYCARDIA AND HYPOTENSION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP WITH THE INDIGO ASPIRATION SYSTEM (CAT12) AND THE INDEX PROCEDURE. ON 16-JAN-2026, CLARIFICATION WAS RECEIVED INDICATING THAT THE SUDDEN ONSET OF BRADYCARDIA, FOLLOWED BY A PAUSE IN CARDIAC RHYTHM, OCCURRED DURING THE INTRODUCTION OF A NON-PENUMBRA SHEATH INTO THE PULMONARY ARTERY, AND PRIOR TO ADVANCEMENT OF THE CAT12. THE PREVIOUSLY REPORTED EPISODE OF DECOMPENSATION WITH BRADYCARDIA AND

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 23660861 ↗
• DeathJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN CRITICAL CONDITION AFTER EXPERIENCING CARDIAC ARREST AND REQUIRING RESUSCITATION. THE PATIENT HAD DEEP LOSS OF CONSCIOUSNESS, WIDE AND NON-REACTIVE PUPILS, AND EXTREME CIRCULATORY AND RESPIRATORY FAILURE. IN LABORATORY TESTS TAKEN PRIOR TO TREATMENT, THERE WAS INTENSIFIED METABOLIC AND RESPIRATORY ACIDOSIS AND EVIDENCE OF LIVER INJURY. THE PATIENT THEN UNDERWENT A SUCCESSFUL THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM IN THE RIGHT AND LEFT PULMONARY ARTERIES AND ITS BRANCHING LOBAR ARTERIES USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, SIGNIFICANT AMOUNTS OF EMBOLIC MATERIAL WERE REMOVED; HOWEVER, TOWARDS THE END OF THE SURGERY THE PATIENT REQUIRED CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) OXYGEN THERAPY TO MAINTAIN ATRIAL OXYGEN SATURATION AT GREATER THAN 80%, AND CATECHOLAMINES INFUSION. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARDIAC CASE UNIT. THE PATIENT THEN EXPERIENCED CIRCULATORY AND RESPIRATORY DECOMPENSATION FOLLOWED BY SUDDEN CARDIAC ARREST DUE

  Patient problems: Cardiac Arrest; Cardiogenic Shock

  MAUDE report 22188679 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT PULMONARY ARTERIES USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A PENUMBRA ENGINE (ENGINE). THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. ON (B)(6) 2025, THE PATIENT DEVELOPED ANEMIA DUE TO IRON DEFICIENCY. THREE UNITS OF BLOOD WERE TRANSFUSED, AND 500 MG OF INTRAVENOUS IRON SUPPLEMENTATION (FERINJECT) WAS ADMINISTERED. THE EVENT IS CONSIDERED RESOLVED. ANEMIA DUE TO IRON DEFICIENCY WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE LIGHTNING ASPIRATION TUBING AND THE INDEX PROCEDURE.

  Patient problems: Anemia

  MAUDE report 22039137 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT DEVELOPED ANEMIA FOLLOWING NECK OF FEMUR SURGERY, WITH HEMOGLOBIN LEVELS MEASURING 7.7 G/DL. ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT UPPER LOBE, RIGHT INTERLOBAR SEGMENT, RIGHT MIDDLE LOBE, LEFT UPPER LOBE, AND LINGULA USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) VIA RIGHT FEMORAL VEIN ACCESS. IT WAS REPORTED THAT THE MOBILE THROMBUS IN THE RIGHT ATRIUM OBSERVED ON THE PRE-PROCEDURAL COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) TAKEN ON (B)(6) 2024, WAS NOT REMOVED. IT WAS REPORTED THAT THE PATIENT WAS ADMINISTERED ANTICOAGULANTS PRIOR TO THE THROMBECTOMY WHICH MAY HAVE BEEN THE REASON THAT THE THROMBUS WAS NOT SEEN VIA IMAGING AT THE TIME. HOWEVER, CONTROL IMAGING CONFIRMED COMPLETE RECANALIZATION OF THE LUNG VESSELS. ESTIMATED BLOOD LOSS WAS 500 ML, AND NO PROCEDURAL COMPLICATIONS WERE REPORTED. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT'S HEMOGLOBIN THEN DROPPED TO 6.8 G/DL, AND A TRANSFUSION OF ONE UNIT OF RED BLOOD CELLS WAS ADMINISTERED. ON (B)(6) 2024, THE PATIENT'S HEMOGLOBIN LEVEL WAS RECHECKED AND FOUND TO BE 7.1 G/DL. ONE ADDITIONAL UNIT OF RED BLOOD CELLS WAS ADMINISTERED TO

  Patient problems: Anemia

  MAUDE report 20547370 ↗
• InjuryJun 21, 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 IN THE LEFT PULMONARY ARTERY, THE LEFT INTERLOBAR SEGMENT, AND THE LEFT LOWER LOBE USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A PENUMBRA ENGINE (ENGINE). THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. ON (B)(6) 2024, THE PATIENT DEVELOPED WORSENING ANEMIA FROM IRON DEFICIENCY AND WAS GIVEN IRON SUPPLEMENTATION. THE EVENT IS CONSIDERED RESOLVED. THE WORSENING ANEMIA WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP WITH THE LIGHTNING AND THE INDEX PROCEDURE.

  Patient problems: Anemia

  MAUDE report 19581295 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN TREATED THE LEFT LUNG BY REMOVING THE THROMBUS UNDER ASPIRATION USING THE CAT12 AND SEP12. SHORTLY BEFORE THE END OF THE PROCEDURE, THE PATIENT STARTED COUGHING BLOOD. THE PHYSICIAN THEN NOTICED BLEEDING FROM A CAPILLARY IN THE LEFT LUNG, INDICATING A VASCULAR RUPTURE. THE PATIENT WAS THEN VENTILATED, AND IT WAS REPORTED THAT THE BLEEDING STOPPED RELATIVELY QUICKLY WITHOUT ANY TREATMENT. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT''S CURRENT HEALTH STATUS IS GOOD, WITH SPONTANEOUS BREATHING THE DAY AFTER THE PROCEDURE. THE RELATIONSHIP BETWEEN HEMOPTYSIS, THE CAT12 AND SEP12 IS UNKNOWN.

  Patient problems: Hemoptysis

  MAUDE report 18351245 ↗