Indigo System LITNG12XTORQ100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948022911), received between Sep 26, 2024 and Mar 17, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERIES AND RIGHT VENTRICLE (RV) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN REMOVED THROMBUS FROM THE TARGET VESSELS. HOWEVER, IT WAS REPORTED RESIDUAL CLOT REMAINED IN THE RV. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. FOLLOWING THE PROCEDURE, THE PATIENT RECEIVED A 10-HOUR INFUSION OF INTRA-ARTERIAL TPA ALTEPLASE. ON (B)(6) 2025, ONE DAY POST PROCEDURE, THE PATIENT¿S VITAL SIGNS WERE STABLE, WITH A HEART RATE OF 80 BEATS PER MINUTE, A RESPIRATORY RATE OF 18 BREATHS PER MINUTE, AND AN OXYGEN SATURATION OF 99%. ON (B)(6) 2025, TWO DAYS POST PROCEDURE, THE PATIENT REPORTED RECURRENT DYSPNEA. AT THAT TIME, THE HEART RATE HAD INCREASED TO 120 BEATS PER MINUTE, THE RESPIRATORY RATE TO 36 BREATHS PER MINUTE, AND THE OXYGEN SATURATION HAD DECREASED TO 80%. IT WAS REPORTED THAT THERE WAS THROMBUS MIGRATION FROM THE RV TO THE PULMONARY ARTERY. THE PATIENT WAS GIVEN INTRAVENOUS (IV) INFUSION (NOREPINEPHRINE & DOBUTAMINE) AND UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT THE MIGRATED THROMBU

  Patient problems: Thromboembolism

  MAUDE report 24614503 ↗
• InjurySep 26, 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 IN THE APICAL SEGMENTAL, RIGHT LOWER LOBE, AND LEFT PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (B)(6), AND A PENUMBRA ENGINE (ENGINE). THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. ON (B)(6) 2024, THE PATIENT¿S GENERAL CONDITION SUDDENLY DETERIORATED, WITH THE OCCURRENCE OF A PULSELESS ELECTRICAL ACTIVITY (PEA) CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND AFTER ADMINISTRATION OF ADRENALINE, THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE PATIENT WAS THEN INTUBATED AND TRANSPORTED FOR A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD AND PULMONARY ARTERIES. THE CT OF THE HEAD REVEALED NO OBVIOUS SIGN OF FRESH BLEEDING, BUT THE CT ANGIOGRAPHY OF THE CHEST SHOWED A RECURRENCE PULMONARY EMBOLISM (PE) IN THE LEFT AND RIGHT PULMONARY ARTERIES. FEATURES OF RIGHT VENTRICULAR OVERLOAD WERE NOTED, INDUCING PULMONARY EDEMA. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL FOR CARDIAC SURGERY AND PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). AFTER SUCCESSFUL TREATMENT, THE PATIENT WAS RETURNED TO THE ORIGINAL HOSPITAL. THE EVENT I

  Patient problems: Pulmonary Embolism

  MAUDE report 20308552 ↗