Indigo Aspiration System IAPS3-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00814548019703), received between Apr 12, 2019 and Jun 5, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A PENUMBRA ENGINE CANISTER (CANISTER) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE CANISTER WAS PLACED IN THE ENGINE, AND NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. THEN, THE PENUMBRA STAFF ATTEMPTED TO TROUBLESHOOT BY RESECURING THE CANISTER AND RESTARTING THE ENGINE. HOWEVER, THE ISSUE WAS NOT RESOLVED; 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 10124536 ↗
• MalfunctionMar 26, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER) AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE CANISTER WOULD NOT CREATE VACUUM AFTER BEING SEATED ON THE ENGINE AND NONE OF THE LIGHTS ON THE ENGINE WOULD TURN ON. 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 9885101 ↗
• MalfunctionMar 25, 2020Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A THE PENUMBRA ENGINE CANISTER (CANISTER) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THREE INDICATOR LIGHTS ON THE ENGINE WERE NOT ILLUMINATING. THE TECHNICIAN REALIZED THAT THE CANISTER WAS NOT SEALED PROPERLY WITH THE PENUMBRA ENGINE (ENGINE) AND ATTEMPTED TO PUSH THE CANISTER DOWN; HOWEVER, THE ISSUE DID NOT RESOLVE. 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 Consequences Or Impact To Patient

  MAUDE report 9881346 ↗
• MalfunctionDec 20, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER) AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE HOSPITAL STAFF SEATED THE CANISTER ON THE ENGINE. WHILE THE ENGINE WAS POWERED ON, NOT ALL FOUR OF THE INDICATOR LIGHTS WERE ILLUMINATED; 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 Consequences Or Impact To Patient

  MAUDE report 9507230 ↗
• MalfunctionOct 8, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE ASPIRATION TUBING TO THE CATHETER AND ATTEMPTED TO INITIATE THE ASPIRATION; HOWEVER, NO VACUUM WAS PRODUCED IN THE CANISTER. IT WAS ALSO REPORTED THAT THE FOUR INDICATOR LIGHTS ON THE PENUMBRA ENGINE (ENGINE) WERE NOT ILLUMINATING. THEREFORE, THE CANISTER WAS REMOVED AND REPLACED WITH A NEW CANISTER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME ENGINE AND THE SECOND CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169848 ↗
• MalfunctionJul 26, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA) USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, AFTER MAKING A SUCCESSFUL PASS USING THE INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) WITH THE PENUMBRA ENGINE PUMP (ENGINE), THE PHYSICIAN REMOVED THE CATRX TO TAKE A FEW PICTURES AND FLUSHED IT. HOWEVER, AFTER REATTACHING THE CATRX AND THE ASPIRATION TUBING (TUBING), THE PHYSICIAN NOTICED ONLY TWO LIGHTS WOULD ILLUMINATE ON THE ENGINE. THEREFORE, THE PHYSICIAN VERIFIED TO ENSURE THE CONNECTIONS BETWEEN THE TUBING AND THE CATRX WERE TIGHT; HOWEVER, THERE WAS NO CHANGE IN ASPIRATION POWER. THEREFORE, THE PHYSICIAN DECIDED TO SWITCH OUT FOR ANOTHER CATRX AS PREFERENCE. THE PROCEDURE WAS COMPLETED USING A NEW CATRX WITH THE SAME ENGINE AND CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833899 ↗
• MalfunctionJun 11, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, IT WAS REPORTED THAT ONLY TWO LIGHTS WERE ILLUMINATING ON THE PENUMBRA SYSTEM ENGINE (ENGINE). THE TECHNICIAN THEN APPLIED PRESSURE TO THE CANISTER AND ALL FOUR LIGHTS ILLUMINATED. THE PROCEDURE WAS THEN CONTINUED IN THIS MANNER. WHEN THE PHYSICIAN WAS MAKING THE THIRD PASS, IT WAS REPORTED THAT ONLY THREE LIGHTS WERE ILLUMINATING ON THE ENGINE; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689139 ↗
• MalfunctionMay 30, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT ILIAC VEIN USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE CANISTER WOULDN'T HOLD PRESSURE. IT WAS REPORTED THAT ONLY TWO OF THE FOUR INDICATOR LIGHTS WOULD ILLUMINATE. THEREFORE, THE CANISTER WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656575 ↗
• MalfunctionMay 16, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PENUMBRA ENGINE (ENGINE) WAS UNABLE TO BUILD VACUUM WITH THE CANISTER AND, THEREFORE, THE PHYSICIAN SWITCHED TO A NEW CANISTER. THE PROCEDURE WAS THEN CONTINUED, AND THE PHYSICIAN USED A CAT8 TO ASPIRATE WITHIN THE PATIENT. AFTER MAKING A PASS, THE CAT8 WAS REMOVED AND FLUSHED ON THE BACK TABLE. HOWEVER, THE PROXIMAL END OF THE CAT8 WAS INADVERTENTLY KINKED WHILE BEING FLUSHED. THE PROCEDURE WAS THEN COMPLETED USING A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615414 ↗
• MalfunctionApr 24, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST PLACED THE CANISTER ON THE PENUMBRA ENGINE (ENGINE), CONNECTED THE ASPIRATION TUBING AND THEN ATTEMPTED TO BUILD NEGATIVE PRESSURE. HOWEVER, THE ENGINE DID NOT BUILD PRESSURE. IT WAS REPORTED THAT ONLY TWO OF THE FOUR LIGHT BARS LIT UP, DESPITE ATTEMPTING TWICE. THEREFORE, THE CANISTER WAS REPLACED AND THE PROCEDURE WAS COMPLETED USING THE SAME ENGINE AND AN INDIGO SYSTEM CAT RX ASPIRATION CATHETER (CATRX). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544902 ↗
• MalfunctionApr 12, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND INDIGO SYSTEM ASPIRATION TUBING (TUBING) FROM AN INDIGO SYSTEM CATRX KIT, AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE CATRX AND REPORTED THAT THE ASPIRATION HAD STOPPED WORKING. HE DECIDED TO REMOVE THE CATRX AND TUBING FROM USE IN THE PATIENT AND CONFIRMED THAT THERE WAS NO ASPIRATION USING THE SYSTEM. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE CATRX, TUBING, AND CANISTER, AND COMPLETED THE PROCEDURE USING A NEW CATRX, NEW TUBING, AND A NEW CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511254 ↗