Indigo System LITNGFHT100BER-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948029446), received between May 2, 2025 and Feb 24, 2026 — classified as 1 death, 2 injuries, 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.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY (PA) USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), A NON-PENUMBRA SELECTION CATHETER, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. TOWARDS THE END OF THE PROCEDURE, A PULMONARY HEMORRHAGE IN THE RIGHT MIDDLE LOBE WAS IDENTIFIED. AS A RESULT OF THE HEMORRHAGE, BLOOD WAS PRESENT IN THE AIRWAY, NECESSITATING RAPID SEQUENCE INDUCTION (RSI) AND ENDOTRACHEAL TUBE (ETT) INTUBATION. THE PATIENT SUBSEQUENTLY EXPERIENCED HEMODYNAMIC COLLAPSE, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, WITH RETURN OF SPONTANEOUS CIRCULATION (ROSC). FOLLOWING BRONCHOSCOPY AND ECHOCARDIOGRAPHIC EVALUATION, THE PROCEDURE WAS ABANDONED, AND ALL DEVICES WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED ISSUE WITH THE FLASH CATHETER OR THE FLASH TUBING DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED INOTROPES (ADRENALINE, NORADRENALINE, VASOPRESSIN, MILRINONE), 1 UNIT OF BLOOD, 1 BOTTLE OF ALBUMIN, AND 2.5 LITERS OF INTRAVENOUS (IV) FLUIDS. AN ADDITIONAL MEDICAL PROCEDURE WAS ALSO PERFORMED TO TREAT THE PATIENT. THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24434217 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22471754 ↗
• MalfunctionJun 7, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE FLASH CATHETER. WHILE TORQUING THE FLASH CATHETER BACK AND FORTH, THE DISTAL END OF THE FLASH CATHETER KINKED IN THE INFERIOR VENA CAVA (IVC). WHEN WITHDRAWING THE FLASH CATHETER, THE DISTAL END OF THE CATHETER WAS NOTICED TO BE IN THE PATIENT'S HEART. THE DISTAL END OF THE FLASH CATHETER WAS REMOVED BY USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW FLASH CATHETER 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 22162120 ↗
• DeathMay 2, 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 LEFT ILIAC AND FEMORAL VEIN FOR A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A BALLOON (10X40), GUIDEWIRES, A MICROSHEATH, AND SHEATHS (6FR AND 16FR) IN A PRONE POSITION VIA THE LEFT LOWER EXTREMITY. DURING THE PROCEDURE, AN INITIAL VENOGRAM WAS TAKEN WHICH SHOWED EXTENSIVE CLOT IN THE FEMORAL, COMMON FEMORAL, AND ILIAC VENOUS SYSTEM. THE 6FR SHEATH WAS UPSIZED TO A 16FR SHEATH. SEVERAL PASSES WERE MADE IN THE TARGET LOCATION USING THE FLASH CATHETER. A VENOGRAM SHOWED SOME RESIDUAL NARROWING OF THE COMMON FEMORAL AND FEMORAL VEIN SO AN ANGIOPLASTY WAS PERFORMED WITH A BALLOON CATHETER. A POST-INTERVENTION VENOGRAM SHOWED NO RESIDUAL STENOSIS. THE VEIN WAS WIDELY PATENT. THE FLASH CATHETER AND SHEATH WERE THEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS PLACED IN A SUPINE POSITION ON THE STRETCHER. IT WAS REPORTED THAT THE PATIENT WAS GETTING READY TO BE EXTUBATED AND BEGAN TO EXPERIENCE OXYGEN DESATURATION AND TACHYCARDIA, WHICH BECAME PROGRESSIVELY WORSE. THE PATIENT THEN BECA

  Patient problems: Pulmonary Embolism

  MAUDE report 21955399 ↗