Indigo System SEP12-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00815948021556), received between Aug 21, 2020 and Nov 17, 2022 — classified as 3 deaths, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT BILATERAL PULMONARY EMBOLISM USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (B)(6) 2022, A NON-PENUMBRA SHEATH AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT12 OVER THE GUIDEWIRE TO THE FACE OF THE CLOT. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE, INTRODUCED THE SEP12 AND STARTED ASPIRATION. WITHIN THE FIRST MINUTE OF ASPIRATION, THE PATIENT BEGAN COUGHING UP BLOOD. THEREFORE, THE PHYSICIAN STOPPED ASPIRATION AND NOTICED THROUGH AN ANGIOGRAM A PERFORATION IN THE PULMONARY ARTERY. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE CAT12 AND THE (B)(6) 2022. THE PROCEDURE WAS ABORTED AT THIS POINT AND THE PATIENT WAS PLACED ON ECMO. A BALLOON WAS PUT IN THE PULMONARY ARTERY TO STOP THE BLEEDING AND THE NEXT DAY, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING A NON-PENUMBRA DEVICE. IT WAS REPORTED THAT THE PATIENT WAS DOING BETTER AND WAS SLOWLY WEANED OFF ECMO. IT WAS ALSO REPORTED THAT THE PHYSICIAN BELIEVED THAT THE PERFORATION OF THE VESSEL OCCURRED DURING INSERTION OF THE SHEATH AND COULD NOT BE ATTRIBUTED TO ANY PENUMBRA DEVICES USED

  Patient problems: Hemoptysis; Perforation of Vessels

  MAUDE report 15820464 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MAIN, LEFT, AND RIGHT PULMONARY ARTERIES USING AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A PENUMBRA ENGINE (ENGINE), AND A LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, AFTER ASPIRATING CLOT USING THE ENGINE AND LIGHTNING FOR APPROXIMATELY 25 TO 30 MINUTES, THE ENGINE FELL OFF THE TABLE AND THE USB CABLE OF THE LIGHTNING BECAME DAMAGED. THEREFORE, THE LIGHTING WAS REMOVED. IT IS UNKNOWN WHAT CAUSED THE ENGINE TO FALL OFF THE TABLE. THE PHYSICIAN THEN CONTINUED TO ENGAGE THE CLOT IN THE TARGET VESSEL USING A NEW LIGHTNING AND THE SAME SEP12, CAT12, AND ENGINE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A PERFORATION OF THE LEFT LOWER PULMONARY ARTERY. THE PHYSICIAN PERFORMED A BRONCHOSCOPY AND INTUBATION AND ADMINISTERED PROTAMINE TO TREAT THE PERFORATION. THE PHYSICIAN THEN PERFORMED A TRACHEOTOMY AND, SUBSEQUENTLY, A MEDICAL PROCEDURE WAS PERFORMED TO TREAT THE TRACHEOTOMY. THE PATIENT ALSO EXPERIENCED HYPOTENSION AND WAS ADMINISTERED MEDICATION TO TREAT IT. THE PROCEDURE ENDED AT THIS POINT WITH AN ESTIMATED BLOOD LOSS OF 350 ML. IT WAS REPORTED THA

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 14844275 ↗
• DeathDec 17, 2021Adverse 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 ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM SEPARATOR 12 (SEP12), AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER INTO THE PULMONARY ARTERY AND INJECTED FOUR MILLIGRAMS OF TISSUE PLASMINOGEN ACTIVATOR (TPA) IN BOTH THE RIGHT AND LEFT LUNG. NEXT, THE CAT12 WAS INSERTED INTO THE MAIN PULMONARY ARTERY ON THE LEFT SIDE TO BEGIN ASPIRATING THE THROMBUS. IT WAS REPORTED THAT THE PHYSICIAN DID NOT FEEL ANY RESISTANCE DURING ADVANCEMENT OF THE CAT12 INTO THE PULMONARY ARTERY OR WHILE ASPIRATING IN THE LEFT MAIN MEDIAL PART OF THE PULMONARY ARTERY USING THE CAT12 AND SEP12. AFTER A COUPLE OF MINUTES OF ASPIRATION, THE PATIENT BEGAN TO EXPERIENCE HEMOPTYSIS AND, THEREFORE, THE PHYSICIAN STOPPED ASPIRATION AND THE PATIENT STABILIZED. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A HAND INJECTED ANGIOGRAPHY THAT DID NOT REVEAL ANY SIGNS OF TRAUMA; HOWEVER, THE PHYSICIAN DID NOTICE INFILTRATION IN THE LUNGS. IT WAS ALSO REPORTED THE CAUSE OF THE INFILTRATION OF THE LUNGS WAS UNKNOWN. THE PHYSICIAN DECIDED TO END THE

  Patient problems: Hemoptysis; Perforation of Vessels

  MAUDE report 13031216 ↗
• InjuryNov 18, 2021Adverse 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 CAT12 ASPIRATION CATHETER (CAT12) AND AN INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, THE PHYSICIAN PERFORMED THROMBECTOMY IN THE RIGHT PULMONARY ARTERY USING THE CAT12. THE PHYSICIAN THEN COMPLETED THREE PASSES IN THE LEFT PULMONARY ARTERY. SUBSEQUENTLY, WHILE PERFORMING ASPIRATION DURING THE NEXT PASS, THE PATIENT STARTED COUGHING AND EXPERIENCED HEMOPTYSIS. THEREFORE, THE CAT12 WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT EXPERIENCE RESISTANCE WHILE USING THE CAT12 AND SEP12. IT WAS ALSO REPORTED THAT THERE WAS NO NOTICEABLE DAMAGE TO THE CAT12 OR SEP12. THE PROCEDURE ENDED AT THIS POINT AND THE PATIENT WAS INTUBATED AND WAS TAKEN FOR A COMPUTED TOMOGRAPHY (CT) SCAN.

  Patient problems: Cough; Hemoptysis

  MAUDE report 12835917 ↗
• DeathOct 22, 2021Adverse 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 DEEP VEIN THROMBOSIS (DVT) IN THE POPLITEAL, FEMORAL AND ILIAC VEINS USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12) AND AN INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, AFTER REMOVING SIGNIFICANT CLOT IN THE PATIENTS VESSELS, THE PATIENT EXPERIENCED A SADDLE PULMONARY EMBOLISM. THE PHYSICIAN ATTEMPTED TO REMOVE CLOT IN THE RIGHT ATRIUM USING THE CAT12; HOWEVER, WAS UNSUCCESSFUL. THE PATIENT HAD CARDIAC FAILURE AND EXPIRED. THERE WAS NO REPORTED DAMAGE TO THE CAT12. THE PATIENT¿S CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 12682960 ↗
• MalfunctionSep 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERIES USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO INSERT THE SEP12 THROUGH THE RHV ON THE FIRST ATTEMPT; HOWEVER, UPON REMOVING THE SEP12 AND ATTEMPTING TO REINSERT IT THROUGH THE RHV AGAIN, THE SEP12 WOULD NOT GO INTO THE RHV. SUBSEQUENTLY, THE PHYSICIAN REMOVED AND REPLACED THE RHV WITH A NEW RHV FROM ANOTHER LIGHTNING KIT; HOWEVER, WHEN ATTEMPTING TO INSERT THE SEP12 THROUGH THE RHV, THE SAME ISSUE OCCURRED. THEREFORE, THE RHV AND SEP12 WERE REMOVED. NEXT, THE PHYSICIAN OPENED A NEW LIGHTNING 8 KIT TO OBTAIN A SMALLER RHV AND COMPLETED ONE PASS USING THE SMALLER RHV AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). WHILE USING THE SEP8 DURING THE SECOND PASS, THE PHYSICIAN NOTICED THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD BROKEN OFF IN THE RIGHT PULMONARY ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN SEP8. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT12 FROM THE FIRST LIGHTNING KIT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457856 ↗
• MalfunctionOct 31, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), INDIGO SYSTEM SEPARATOR 12 (SEP12), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE TARGET VESSEL USING THE SHEATH. AN ANGIOGRAM WAS PERFORMED, WHICH SHOWED A LOT OF CLOT WAS PRESENT. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO USE THE SEP12, BUT THE SEP12 WOULD NOT ADVANCE INTO THE OPENED ROTATING HEMOSTASIS VALVE (RHV), AND THE DISTAL END OF THE SEP12 WAS INADVERTENTLY KINKED. THEREFORE, THE RHV AND SEP12 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND SEP12 AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10767102 ↗
• MalfunctionAug 21, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 12 (SEP12) AND AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT THE SEP12 THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) OF THE CAT12, AND SUBSEQUENTLY, THE SEP12 WAS UNABLE TO ADVANCE THROUGH. THEREFORE, THE SEP12 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME RHV AND THE SAME CAT12 WITHOUT A SEP12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10439831 ↗