Penumbra System IAPS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548013343), received between Dec 11, 2017 and Jul 25, 2019 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CIRCUMFLEX ARTERY USING AN INDIGO SYSTEM CAT RX KIT, AN INDIGO PUMP MAX CANISTER (CANISTER), A PUMP MAX CANISTER (CANISTER), AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) INTO THE TARGET VESSEL, CONNECTED THE PUMP MAX AND INITIATED THE ASPIRATION; HOWEVER, NO VACUUM WAS PRODUCED. THEREFORE, THE CATRX AND CANISTER WERE REMOVED. THE PHYSICIAN THEN PLACED A NEW CATRX AND CANISTER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER THROMBECTOMY DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826455 ↗
• MalfunctionFeb 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING AN INDIGO PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE PENUMBRA SYSTEM PUMP MAX 110V (PUMP MAX) TO ASPIRATE AND NOTICED THAT THE CANISTER BEGAN FILLING WITH FOAM. THE PENUMBRA SALES REPRESENTATIVE (REPRESENTATIVE) DISCONNECTED AND RECONNECTED THE ASPIRATION TUBING SEVERAL TIMES IN ORDER TO DEPRESSURIZE THE CANISTER AND ALLOW THE FOAM TO RECEDE. DUE TO THIS, THE REPRESENTATIVE DECIDED TO REPLACE THE CANISTER AS THIS PROCESS WAS BEGINNING TO INTERRUPT THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364679 ↗
• MalfunctionFeb 15, 2019Suction Problem; Suction Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) WAS UNABLE TO ACHIEVE FULL VACUUM. THE HOSPITAL STAFF CHECKED ALL THE CONNECTIONS, HOWEVER, THE PUMP MAX WAS STILL UNABLE TO ACHIEVE FULL VACUUM. THEREFORE, THE INDIGO PUMP MAX CANISTER (CANISTER) WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW CANISTER.

  Patient problems: No Patient Involvement

  MAUDE report 8346092 ↗
• MalfunctionFeb 14, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING AN INDIGO SYSTEM CAT RX KIT AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ASPIRATE THE CLOT USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND WAS UNABLE TO GET SUCTION THROUGH THE CATRX WITH THE PUMP MAX. THEREFORE, BOTH THE CATRX AND PUMP MAX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339156 ↗
• MalfunctionNov 2, 2018Decrease in Suction; Suction Problem; Decrease in Suction; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON THE POSTERIOR TIBIAL ARTERY USING AN INDIGO PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, A PENUMBRA STAFF NOTICED THE VACUUM PRODUCED BY THE PENUMBRA SYSTEM ASPIRATION PUMP MAX (PUMP MAX) WENT DOWN TO -29INHG. AFTER TROUBLESHOOTING, THE PENUMBRA STAFF DECIDED TO REPLACE THE CANISTER WITH A NEW ONE AND FULL VACUUM POWER WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035802 ↗
• MalfunctionNov 2, 2018Crack; Crack

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE CANISTER WAS CRACKED AND, THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032925 ↗
• MalfunctionDec 11, 2017Crack; Crack

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR AN IN-STENT RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, WHILE USING THE SEP6 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), THE PHYSICIAN NOTICED THAT THE INDIGO SYSTEM WAS NOT ASPIRATING PROPERLY. UPON CHECKING THE SYSTEM, THE HOSPITAL STAFF NOTICED THAT THE CANISTER HAD A CRACK IN THE SIDE. THEREFORE, THE CANISTER WAS REPLACED WITH A NEW ONE AND ASPIRATION WORKED WITHOUT ISSUES. LATER IN THE PROCEDURE, THE SCRUB TECHNOLOGIST INADVERTENTLY KNOCKED THE SEP6 ONTO THE FLOOR. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW SEP6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106905 ↗