Indigo System LITNGFHT100BER-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948024885), received between Jun 5, 2023 and Feb 23, 2024 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 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 RIGHT AND LEFT PULMONARY ARTERIES USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), A NON-PENUMBRA BALLOON TIPPED DIAGNOSTIC CATHETER (100CM), A NON-PENUMBRA SHEATH, AN EXCHANGE LENGTH WIRE, AND A GUIDEWIRE. DURING THE PROCEDURE, SEVERAL PASSES WERE COMPLETED IN THE LEFT AND RIGHT PULMONARY ARTERIES USING THE FLASH CATHETER. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT STARTED TO CODE. AN ANGIOGRAM WAS PERFORMED USING A BALLOON TIPPED DIAGNOSTIC CATHETER AND REVEALED VESSEL PERFORATION IN THE PROXIMAL PORTION OF THE MAIN PULMONARY ARTERY. THE PHYSICIAN THEN PLACED A TRANSVERSE ABDOMINIS PLANE (TAP) DRAINAGE CATHETER IN THE PATIENT TO RELEASE BLOOD FROM THE PERICARDIUM. IT WAS REPORTED THAT THE PATIENT IS NOW FULLY FUNCTIONING AND HAS MADE MAJOR PROGRESS.

  Patient problems: Great Vessel Perforation

  MAUDE report 18773344 ↗
• DeathOct 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING). DURING THE PROCEDURE, THE PHYSICIAN MADE THREE PASSES AND WAS ABLE TO SUCCESSFULLY REMOVE CLOT FROM THE TARGET VESSEL USING THE FLASH CATHETER. IT WAS REPORTED THE PATIENT¿S OXYGEN LEVEL INCREASED FROM 65% TO 85%. THE FLASH CATHETER WAS REMOVED TO BE FLUSHED. WHILE ADVANCING THE FLASH CATHETER BACK INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND TORQUED THE FLASH CATHETER. THE PATIENT¿S HEALTH CONDITION THEN DECLINED. THE PHYSICIAN PERFORMED AN ANGIOGRAM AND NOTICED A PERFORATION IN THE MAIN PULMONARY ARTERY. IT WAS REPORTED THAT THE PATIENT LATER EXPIRED. THE CAUSE OF DEATH WAS THE MAIN PULMONARY ARTERY PERFORATION. THE CAUSE OF THE PERFORATION IS UNKNOWN.

  Patient problems: Perforation of Vessels; Unspecified Vascular Problem

  MAUDE report 17857870 ↗
• DeathJun 5, 2023Adverse 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 ARTERIES USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER) AND A NON-PENUMBRA GUIDE SHEATH. IT SHOULD BE NOTED THAT THE PATIENT HAD AN ECHOCARDIOGRAM (ECHO) STUDY, AND AN ATRIAL SEPTAL DEFECT WAS FOUND ON THE ECHO. IT WAS ALSO REPORTED THAT THE PATIENT WAS OBESE AND WAS COMPLAINING OF TIGHTNESS IN CHEST. THE PATIENT WAS ALSO EXPERIENCING HEAVY SWEATING AND HAD A MULTITUDE OF COLD COMPRESSES PLACED. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ACCESS THE TARGET VESSEL USING THE GUIDE SHEATH; HOWEVER, HE HAD DIFFICULTY GAINING ACCESS. AFTER OVER AN HOUR, ACCESS WAS GAINED TO THE LEFT PULMONARY ARTERY AND THE FLASH CATHETER WAS ADVANCED INTO THE CLOT; HOWEVER, THE FLASH TUBING IMMEDIATELY WENT INTO A FLASHING YELLOW MODE WITHOUT A CLICKING SOUND. IT WAS REPORTED THAT THE FLASH CATHETER WAS NOT ASPIRATING BLOOD. THEREFORE, THE FLASH CATHETER WAS REMOVED, AND NO CLOT WAS NOTICED TO BE PRESENT IN THE FLASH CATHETER. THE PHYSICIAN RE-ADVANCED THE FLASH CATHETER INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUE OCCURRED. THE FLASH CATHE

  Patient problems: Cardiac Tamponade

  MAUDE report 17056871 ↗