Indigo System LITNGFHT100H1-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815948029880), received between Jan 17, 2025 and Mar 24, 2026 — classified as 1 death, 3 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse 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), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AND AN ELEMENT VASCULAR ACCESS SHEATH (ELEMENT SHEATH). IT WAS REPORTED THAT DURING THE PROCEDURE, THE HEMOLOCK VALVE SYSTEM WAS LEAKING; HOWEVER, THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SAME ELEMENT SHEATH. ON 24-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL TEAM THAT POST-PROCEDURE, THERE WAS ACCESS SITE BLEEDING AND AN ECCHYMOSIS. TWO-DAYS POST PROCEDURE, THE HEMOGLOBIN DROPPED TO 7.8 G/DL. ONE UNIT OF PACKED RED BLOOD CELLS (PRBCS) WAS GIVEN. THE SITE REMAINED SOFT WITHOUT A HEMATOMA. ACUTE BLOOD LOSS ANEMIA WAS DETERMINED BY THE INDEPENDENT MEDICAL REVIEWER (IMR) TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS CONSIDERED RESOLVED.

  Patient problems: Anemia

  MAUDE report 24678799 ↗
• MalfunctionMar 18, 2026

  WHILE PRIMING THE THROMBECTOMY DEVICE ON THE TABLE WE NOTICED THE DEVICES ELECTRONICS WAS DEFECTIVE. WE TRIED A FEW TIMES WITH THE SUPPORT OF THE REP FORM PENUMBRA TO TROUBLE SHOOT THE ERROR BUT NO LUCK. ITEM WAS NEVER USED ON PATIENTS. ITEM REMOVED FROM FIELD AND NEW PRODUCT OPENED ON FIELD THAT WORK WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626093 ↗
• DeathFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER). FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTY BREATHING, HEMOPTYSIS, AND LARGE VOLUME BLOOD LOSS, WHICH REQUIRED ASPIRATION. THE PATIENT WAS INTUBATED INTO THE RIGHT BRONCHUS DUE TO THE INJURY IN THE LEFT LUNG. THE PATIENT LOST PULSES, PROMPTING THE EMERGENCY RESPONSE TEAM TO ADMINISTER CARDIOPULMONARY RESUSCITATION (CPR). IT WAS REPORTED BILATERAL GROIN ACCESS WAS ATTEMPTED FOR TRANSFUSION PROTOCOL. IT IS UNKNOWN IF ACCESS WAS SUCCESSFUL AND TRANSFUSION WAS PERFORMED. AFTER TWENTY MINUTES OF CPR, THE PATIENT EXPIRED. PERFORATION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM (FLASH CATHETER), AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 24278582 ↗
• InjuryApr 25, 2025Adverse 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 BILATERAL PULMONARY ARTERIES TO TREAT PULMONARY EMBOLISM (PE) USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), CATHETER (6FR PIGTAIL), GUIDEWIRE (LONG J WIRE), AND SHEATHS (7FR AND 16FR) VIA THE RIGHT GROIN. DURING THE PROCEDURE, THE PIGTAIL CATHETER WAS ADVANCED AND BILATERAL PULMONARY ANGIOGRAMS WERE TAKEN. NEXT, THE 7FR SHEATH WAS UPSIZED TO THE 16FR SHEATH. MULTIPLE PASSES WERE COMPLETED WITH THE FLASH CATHETER IN THE TARGET LOCATIONS. POST ASPIRATION ANGIOGRAMS SHOWED SIGNIFICANT REDUCTION IN CLOT BILATERALLY. THE PROCEDURE WAS COMPLETED. THE SHEATH WAS REMOVED AND HEMOSTASIS WAS ACHIEVED WITH A FIGURE 8 SUTURE. IT WAS REPORTED THAT ON (B)(6) 2024, PURULENT FOUL-SMELLING DRAINAGE FROM THE RIGHT GROIN AT THE PREVIOUS VENOUS SHEATH SITE WAS NOTED WITH BLEEDING, BACTEREMIA WAS DIAGNOSED AND VANCOMYCIN WAS PRESCRIBED. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) DUE TO THE RIGHT GROIN WOUND WITH PURULENT DRAINAGE, NO BLOOD, NO ERYTHEMA, AND NON-TENDER. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND DISCHARGED HOME. HEMATOMA WAS REPORTED TO BE AN ADVERSE EVENT WITH A PROBABLE

  Patient problems: Hematoma

  MAUDE report 21914013 ↗
• InjuryMar 14, 2025Adverse 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), AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NON-PENUMBRA FLUSH CATHETER (16FR), AND A NON-PENUMBRA FLOWTRIEVER SYSTEM. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ON (B)(6) 2025, ONE DAY POST-PROCEDURE, IT WAS REPORTED THAT THE PATIENT DEVELOPED HYPOTENSION IN THE SETTING OF LOW HEMOGLOBIN (HGB). AT 9:58AM THE BLOOD PRESSURE WAS 113/70. AT 11:45AM THE BLOOD PRESSURE WAS 83/54. PRE-PROCEDURE, THE HGB WAS 12.1, ONE-DAY POST INDEX PROCEDURE, THE HGB WAS 8.0. TWO-DAY POST INDEX PROCEDURE, THE HGB WAS 8.0. A BLOOD TRANSFUSION WAS GIVEN. LOW BLOOD PRESSURE WAS DETERMINED BY THE INDEPENDENT MEDICAL REVIEWER (IMR) TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT WAS CONSIDERED TO BE RESOLVED WITH CLINICAL SEQUELAE ON (B)(6) 2024. LOW HEMOGLOBIN WAS DETERMINED BY THE IMR TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A PROBABLE RELATIO

  Patient problems: Anemia; Low Blood Pressure/ Hypotension

  MAUDE report 21610833 ↗
• MalfunctionJan 17, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND DISTAL FEMORAL VEIN USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE MAKING THE FIRST PASS WITH THE FLASH CATHETER, THE PHYSICIAN FELT RESISTANCE. UNDER FLUOROSCOPY, THE FLASH CATHETER WAS NOTICED TO BE KINKED BETWEEN THE PROXIMAL AND MID-SHAFT. THE PHYSICIAN DECIDED TO REMOVE THE FLASH CATHETER. WHILE RETRACTING, THE FLASH CATHETER FRACTURED AT THE KINKED LOCATION; THEREFORE, THE PROXIMAL PORTION OF THE FLASH CATHETER WAS REMOVED. A SNARE DEVICE WAS ADVANCED TO REMOVE THE DISTAL PORTION OF THE FLASH CATHETER; HOWEVER, WHILE RETRACTING, THE SNARE LOST HOLD OF THE DISTAL SEGMENT. THEREFORE, THE REMAINING SEGMENT WAS REMOVED VIA CUTDOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181706 ↗