Indigo System LITNGFHT115BER-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948029453), received between Sep 4, 2024 and Mar 16, 2026 — classified as 1 death, 2 injuries.

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

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT MIXED ACUTE, SUBACUTE, CHRONIC PULMONARY EMBOLISM (PE) ON (B)(6) 2025 USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NEURON SELECT CATHETER 6F (6F SELECT), AN INDIGO SYSTEM SEPARATOR 12 ((B)(6)), A PENUMBRA ENGINE (ENGINE), AND A GUIDEWIRE. IN THE IMMEDIATE POSTOPERATIVE PERIOD, THE PATIENT PRESENTED WITH RESPIRATORY DECOMPENSATION AND MASSIVE HEMOPTYSIS REQUIRING OROTRACHEAL INTUBATION AND MECHANICAL VENTILATION. IT WAS REPORTED THIS WAS LIKELY DUE TO A REPERFUSION INJURY. THE PATIENT WAS REPORTED TO BE HEMODYNAMICALLY STABLE WITHOUT VASOPRESSOR USE AND WAS PLACED ON FIO2 100% WITH O2 SATS OF 94% AND TRANSFERRED BACK TO THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2025, THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS EXTUBATED WITH GRADUAL INCREASE OF OXYGEN REQUIREMENTS. THE PATIENT WAS ALSO STARTED ON A BLOOD THINNER (CLEXANE, ENOXAPARIN SODIUM). ON (B)(6) 2025, THE PATIENT WAS TRANSITIONED TO ANOTHER BLOOD THINNER (MAREVAN, WARFARIN SODIUM) WHILE CONTINUING CLEXANE AS A BRIDGE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025 WITH SLIGHT DYSPNEA. THE PATIENT MISSED THE 90-DAY FOLLOW-UP APPOINTMENT. THE R

  Patient problems: Reperfusion Injury

  MAUDE report 24607529 ↗
• DeathAug 7, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM IN THE RIGHT AND LEFT LUNGS USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER). IT SHOULD BE NOTED THAT THE PATIENT WAS ALREADY IN CRITICAL CONDITION AND IN A COMA PRIOR TO BEFORE THE PROCEDURE, WITH A CHRONIC THROMBUS PRESENT IN ONE LUNG AND HEMODYNAMIC INSTABILITY. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ASPIRATED THROMBUS IN ONE LUNG USING THE FLASH CATHETER. WHILE REPOSITIONING THE FLASH CATHETER TO OTHER LUNG WHERE THROMBUS WAS LOCATED, THE PATIENT WENT INTO CARDIAC ARREST. THE MEDICAL TEAM ATTEMPTED TO RESUSCITATE THE PATIENT BUT THE PATIENT ULTIMATELY EXPIRED. THERE WAS NO DAMAGE NOTED ON THE FLASH CATHETER UNDER FLUOROSCOPY. AFTER THE PATIENT EXPIRED, THE FLASH CATHETER FROM THE PATIENT. THE PHYSICIAN NOTICED THAT THE DISTAL LENGTH OF THE FLASH CATHETER WAS FRACTURED. A SNARE DEVICE WAS USED TO REMOVE THE FRACTURED FLASH CATHETER FROM THE PATIENT. THE PHYSICIAN DETERMINED THAT THE DAMAGE TO THE FLASH CATHETER MAY HAVE OCCURRED DUE TO EXCESSIVE RESUSCITATION EFFORTS. IT WAS ALSO REPORTED THAT THE FLASH CATHETER DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742292 ↗
• InjurySep 4, 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 USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER. DURING THE PROCEDURE, POST FIRST CLOT REMOVAL THE PATIENT EXPERIENCED SUPRA VENTRICULAR TACHYCARDIA (SVT). THEN THE HEART RATE (HR) DECREASED (BRADYCARDIA) FROM 152 TO 66 BEATS PER MINUTE (BPM), SYSTOLIC BLOOD PRESSURE (BP) DECREASED FROM 134 MMHG TO 109 MMHG WHICH WAS LIKELY A VAGAL EPISODE. THE EVENT RESOLVED WITH HR AT 109 BPM. ATROPINE WAS ADMINISTERED AND THROMBUS REMOVAL WAS CONTINUED. SVT WAS UNRELATED TO THE INDIGO SYSTEM. BRADYCARDIA WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO SYSTEM AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS CONSIDERED RESOLVED.

  Patient problems: Bradycardia

  MAUDE report 20141482 ↗