Penumbra System PAPS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00814548012384), received between Nov 25, 2015 and Oct 30, 2023 — classified as 1 injury, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE POSTERIOR SEGMENTAL, RIGHT LOWER LOBE, ANTERIOR BASAL SEGMENTAL, LATERAL BASAL SEGMENTAL, MEDIAL BASAL SEGMENTAL, POSTERIOR BASAL SEGMENTAL, APICAL SEGMENTAL, LINGULAR, AND LEFT LOWER LOBE USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION CATHETER (FLASH CATHETER). FOLLOWING THE COMPLETION OF THROMBECTOMY, THE PATIENT REPORTED DIZZINESS AND HYPOTENSION WAS REPORTED. THE PHYSICIAN PROVIDED THE PATIENT FLUID RESUSCITATION WITH 500 ML OF NORMAL SALINE IN A PRESSURE BAG. THE EPISODE OF HYPOTENSION WAS CONSIDERED VASOVAGAL, NOT SECONDARY TO BLOOD LOSS. IT WAS REPORTED THAT BLOOD TRANSFUSION WAS PERFORMED. HYPOTENSION WAS CONSIDERED POSSIBLY RELATED TO THE INDIGO ASPIRATION SYSTEM AND POSSIBLY RELATED TO THE INDEX PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18036069 ↗
• MalfunctionApr 2, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PUMP MAX CANISTER (CANISTER) AND PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE CANISTER TO THE PUMP MAX AND ADJUSTED THE REGULATOR KNOB AFTER TURNING ON THE POWER; HOWEVER, THE PUMP MAX WAS UNABLE TO ACHIEVE FULL ASPIRATION. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919066 ↗
• MalfunctionDec 27, 2019Break; Suction Problem; Break; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PUMP MAX CANISTER (CANISTER) AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN WAS ASPIRATING IN THE TARGET VESSEL USING THE ACE68 AND NOTICED THAT ASPIRATION HAD DECREASED. SUBSEQUENTLY, A CRACK ON THE LID OF THE CANISTER WAS FOUND. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9527658 ↗
• MalfunctionDec 3, 2019Device Contamination with Body Fluid; Device Contamination with Body Fluid

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA MAX CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE TUBING CONNECTED TO THE FILTER OF THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) HAD BLOOD IN IT; THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407007 ↗
• MalfunctionNov 25, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL AND ILIAC VEINS USING A PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN SEATED THE CANISTER ONTO THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) AND WAS ABLE TO ASPIRATE APPROXIMATELY 300 CM OF BLOOD/ FLUSH. THE PUMP MAX THEN STOPPED PRODUCING VACUUM; THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372544 ↗
• MalfunctionAug 15, 2019Suction Problem; Noise, Audible; Suction Problem; Noise, Audible

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE OF THE ACUTE CEREBRAL USING A PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE ASPIRATION PRESSURE WOULD ONLY REACH -10 INHG AND THE CANISTER MADE SOUND OF LEAKING AIR. THEREFORE, THE PHYSICIAN REMOVED THE CANISTER AND 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 8898474 ↗
• MalfunctionJul 31, 2019Crack; Crack

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) COULD NOT ACHIEVE ANY VACUUM. AFTER TROUBLESHOOTING, IT WAS NOTED THAT THE CANISTER WAS CRACKED AND, THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846897 ↗
• 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 8826464 ↗
• MalfunctionApr 25, 2019Dent in Material; Dent in Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE OF THE ACUTE CEREBRAL INFARCTION IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, AFTER PLACING THE CANISTER ON THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX) AND CONNECTING THE ASPIRATION TUBING (TUBING) TO A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), THE LID OF THE CANISTER BECAME DENTED AFTER ASPIRATION HAD STARTED AT -28 INHG. AFTER MAKING A SUCCESSFUL PASS WITH THE 4MAXC, THE PHYSICIAN DECIDED TO DISCONTINUE USING THE CANISTER. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER WITH THE SAME 4MAXC, A NON-PENUMBRA STENT RETRIEVER, THE SAME TUBING AND THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552613 ↗
• MalfunctionMay 16, 2018Air Leak; Air Leak

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO PUMP MAX CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX), THE ASPIRATION TUBING (TUBING), THE CANISTER, AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND BEGAN ASPIRATING WITHIN THE PATIENT. WHILE ASPIRATING, THE PUMP MAX WAS ONLY ABLE TO CREATE A SUCTION OF -10 TO -15 MMHG. THE PHYSICIAN, THEREFORE, TURNED OFF THE PUMP MAX AND CHECKED EACH OF THE CONNECTIONS IN THE SYSTEM, AND THEN RE-ATTEMPTED TO ASPIRATE. THE PUMP MAX WAS STILL UNABLE TO CREATE A SUCTION GREATER THAN -10 TO -15 MMHG, AND THE PHYSICIAN THEN NOTICED AN AIR LEAKAGE SOUND COMING FROM NEAR THE CANISTER FILTER. THE PHYSICIAN, THEREFORE, COMPLETED THE PROCEDURE USING MANUAL ASPIRATION AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7518385 ↗
• MalfunctionMar 9, 2017Occlusion Within Device; Device Handling Problem; Occlusion Within Device; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM PUMP CANISTER KIT. DURING THE PROCEDURE, WHILE ATTEMPTING TO INITIATE ASPIRATION FOR THE FIRST PASS, THE HOSPITAL STAFF ACCIDENTALLY DID NOT REMOVE A PLASTIC FILM FROM THE CANISTER LID, WHICH OBSTRUCTED THE ASPIRATION TUBING. CONSEQUENTLY, THERE WAS NO BLOOD FLOW INTO THE CANISTER. AFTER THE PLASTIC FILM WAS REMOVED, ANOTHER ATTEMPT WAS MADE TO ASPIRATE THE BLOOD CLOT USING THE SAME PENUMBRA SYSTEM. THEREAFTER, THE BLOOD CLOT WAS COMPLETELY REMOVED AND THE PATIENT'S THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE WAS A 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6392873 ↗
• MalfunctionNov 25, 2015Suction Problem; Aspiration Issue; Device Operational Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM PUMP MAX CANISTER KIT (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN TURNED ON THE PENUMBRA ASPIRATION PUMP MAX 110 (PUMP MAX) TO ASPIRATE THE THROMBUS BUT WAS UNABLE TO CONFIRM THAT THE THROMBUS WAS DROPPING BACK INTO THE CANISTER. THE PHYSICIAN CONFIRMED THAT THE ASPIRATION TUBING WAS WORKING NORMALLY BECAUSE THE THROMBUS COULD BE SEEN PASSING THROUGH IT. THE ASPIRATION GAUGE WAS ALSO OBSERVED TO BE WORKING NORMALLY. THE PHYSICIAN THEN REMOVED THE CANISTER AND COMPLETED THE PROCEDURE 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 5251994 ↗