Indigo System LITNGFHT115H1-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948029873), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE PULMONARY EMBOLISM IN THE LEFT PULMONARY ARTERY (LPA) AND RIGHT SEGMENTAL BRANCHES USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING) AND AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER). IT WAS NOTED THAT THE PATIENT HAD A RIGHT VENTRICULAR (RV) STRAIN. DURING THE PROCEDURE, THE FLASH CATHETER WAS ADVANCED INTO THE LPA WITHOUT ISSUES AND ASPIRATION WAS INITIATED. AFTER APPROXIMATELY THREE MINUTES OF ASPIRATION, THE PATIENT BEGAN TO COUGH UP BLOOD AND THE PROCEDURE WAS ABORTED. THE PHYSICIAN THEN ADVANCED A BALLOON CATHETER TO STABILIZE THE PATIENT AND PERFORMED AN ANGIOGRAM. HOWEVER, THE PHYSICIAN COULD NOT FIND AN AREA OF PERFORATION. IT WAS REPORTED THAT THE PATIENT DEVELOPED AIRWAY OBSTRUCTION, AND CARDIOPULMONARY ARREST. RESUSCITATION EFFORTS THAT INCLUDED ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) INTERVENTION, CRICOTHYROTOMY, AND MECHANICAL VENTILATION WERE PERFORMED. THE PATIENT WAS ALSO ADMINISTERED PROTAMINE SULFATE, TWO UNITS OF FRESH RED BLOOD CELLS (PRBCS), AND TWO UNITS OF FRESH FROZEN PLASMA (FFP). THE PATIENT WAS ABLE TO REGAIN A STRONG PULSE FOR A SHORT TIME. AFTE

  Patient problems: Hemoptysis

  MAUDE report 21862567 ↗