Indigo IAPS3Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548019765), received between Mar 28, 2019 and Nov 12, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN, ILIAC VEIN, AND INFERIOR VENA CAVA (IVC) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, THE ENGINE WAS UNABLE TO OBTAIN VACUUM AND NONE OF THE INDICATOR LIGHTS WOULD ILLUMINATE ON THE ENGINE USING THE CANISTER. IT WAS ALSO REPORTED THAT THE INDICATOR LIGHT ON THE LIGHTNING UNIT BEGAN FLASHING RED. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER WITH THE SAME ENGINE AND LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801719 ↗
• MalfunctionJul 2, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE HOSPITAL STAFF PLACED THE CANISTER ONTO THE ENGINE AND NOTICED THAT ONLY TWO OF THE FOUR INDICATOR LIGHTS AROUND THE POWER BUTTON ON THE ENGINE WERE ILLUMINATED. IT WAS REPORTED THAT AN ATTEMPT TO TROUBLESHOOT WAS MADE BY REMOVING THE CANISTER AND REATTACHING THE TUBING; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111562 ↗
• MalfunctionJun 26, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT POPLITEAL ARTERY USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN REALIZED THAT THE CANISTER LOST ITS SUCTION; THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS REPORTED THAT THE LID OF THE FIRST CANISTER WAS NOT THREADED PROPERLY AND WHEN TIGHTENED APPROPRIATELY, IT WORKED. HOWEVER, THE SECOND CANISTER WAS ALREADY BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072368 ↗
• MalfunctionJun 9, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN NOTICED NONE OF THE INDICATOR LIGHTS ON THE ENGINE WOULD ILLUMINATE AND THE ENGINE WAS NOT GENERATING ASPIRATION. THE GROMMETS NEAR THE CANISTERS WERE REMOVED IN AN ATTEMPT TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE VACUUM RELEASE LEVER WAS DEPRESSED. THEREFORE, ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A MANUAL ASPIRATION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971312 ↗
• MalfunctionMar 18, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED SOLID RED AFTER TURNING THE FLOW SWITCH TO THE ON POSITION. TO TROUBLESHOOT, THE PHYSICIAN UNPLUGGED AND PLUGGED BACK IN THE CORD FROM THE LIGHTNING TO THE USB PORT ON THE ENGINE, FLUSHED THE CAT8 AND TUBING, AS WELL AS MAKING SURE THAT THE CANISTER WAS SEATED PROPERLY ON THE ENGINE. HOWEVER, THE LIGHTNING UNIT REMAINED SOLID RED AND NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. SUBSEQUENTLY, THE LIGHTNING WAS REMOVED AND EXCHANGED FOR A NEW LIGHTNING, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN THEN EXCHANGED THE ENGINE FOR A SECOND ENGINE, BUT THE LIGHTNING UNIT REMAINED SOLID RED AND NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. THEREFORE, THE PHYSICIAN REMOVED THE CANISTER. IT WAS ALSO REPORTED THAT THE FIRST ENGINE WAS TESTED WITH THE NEW CANISTER AND IT WAS NOTED THAT THE ENGINE WAS ABLE TO ACHIEVE FULL ASPIRATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510461 ↗
• MalfunctionJan 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL ARTERY USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF SETUP THE CANISTER AND ENGINE. AFTER TURNING ON THE ENGINE, IT WAS NOTICED THAT THE VACUUM PRESSURE WAS LOW AND THE INDICATOR LIGHTS ON THE ENGINE DID NOT ILLUMINATE. THEREFORE, THE ENGINE AND CANISTER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER THROMBECTOMY SYSTEM. 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 11191335 ↗
• MalfunctionAug 21, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA (IVC) USING A PENUMBRA ENGINE CANISTER (CANISTER), A PENUMBRA ENGINE (ENGINE), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A SHEATH, AND GUIDEWIRE. DURING THE PROCEDURE, THE CAT8 WAS ADVANCED OVER THE GUIDEWIRE AND THROUGH A SHEATH. NEXT, THE ENGINE WITH THE CANISTER WAS CONNECTED TO THE CAT8 AND THE ENGINE WAS POWERED ON. HOWEVER, NOT ALL FOUR OF THE INDICATOR LIGHTS ON THE ENGINE ILLUMINATED AND MAXIMUM VACUUM PRESSURE WAS NOT ACHIEVED. TO TROUBLESHOOT, THE CANISTER WAS REMOVED AND PLACED BACK INTO THE ENGINE THREE TIMES. IN ADDITION, THE ENGINE WAS POWERED OFF AND POWERED ON THREE TIMES; HOWEVER, THE ISSUE WAS NOT RESOLVED. THEREFORE, THE ENGINE WAS DISCONNECTED AND REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE USING ANOTHER ENGINE AND THE SAME CANISTER, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SECOND ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437135 ↗
• MalfunctionJul 30, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT PULMONARY ARTERY USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, WHILE ATTEMPTING TO START ASPIRATION, THE PHYSICIAN NOTICED NONE OF THE LIGHTS ON THE ENGINE WOULD NOT ILLUMINATE. THE CANISTER WAS REPOSITIONED MULTIPLE TIMES ON THE ENGINE; HOWEVER, THE LIGHTS ON THE ENGINE WOULD NOT ILLUMINATE. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347545 ↗
• MalfunctionMar 28, 2019Decrease in Pressure; Pressure Problem; Decrease in Pressure; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, AFTER ACCUMULATING 75 CC OF BLOOD, A PENUMBRA STAFF DISCOVERED ONLY THREE LIGHTS ON THE PENUMBRA ENGINE (ENGINE) WOULD ILLUMINATE. HOWEVER, ALL FOUR LIGHTS WOULD ILLUMINATE WHEN THE PENUMBRA STAFF HELD HIS FINGER OVER THE VENTILATION HOLE ON THE LID OF THE CANISTER. IT WAS REPORTED THAT THE PROCEDURE CONTINUED WITH ONLY THREE LIGHTS ON THE ENGINE AND THE HOLE WAS COVERED WHEN NEEDED BY THE PENUMBRA STAFF. THE PROCEDURE WAS COMPLETED USING THE SAME ENGINE WITH THE SAME CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461284 ↗