Indigo System SEP12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815948021549), received between Dec 18, 2023 and Sep 26, 2024 — 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. How this data works · Data updated Oct 13, 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.

• 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 20308561 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN TREATED THE LEFT LUNG BY REMOVING THE THROMBUS UNDER ASPIRATION USING THE CAT12 AND SEP12. SHORTLY BEFORE THE END OF THE PROCEDURE, THE PATIENT STARTED COUGHING BLOOD. THE PHYSICIAN THEN NOTICED BLEEDING FROM A CAPILLARY IN THE LEFT LUNG, INDICATING A VASCULAR RUPTURE. THE PATIENT WAS THEN VENTILATED, AND IT WAS REPORTED THAT THE BLEEDING STOPPED RELATIVELY QUICKLY WITHOUT ANY TREATMENT. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT''S CURRENT HEALTH STATUS IS GOOD, WITH SPONTANEOUS BREATHING THE DAY AFTER THE PROCEDURE. THE RELATIONSHIP BETWEEN HEMOPTYSIS, THE CAT12 AND SEP12 IS UNKNOWN.

  Patient problems: Hemoptysis

  MAUDE report 18351252 ↗