Penumbra System PAPS3Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00814548019758), received between Sep 22, 2020 and Sep 16, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE 3MAXC. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT BLOOD WAS SLOWLY ASPIRATED BACK INTO THE CANISTER AND ONLY THREE INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. IT WAS REPORTED THAT THE LID OF THE CANISTER AND SETTING WAS INSPECTED. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER WITH THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482202 ↗
• MalfunctionSep 15, 2021Crack; Suction Problem; Crack; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, ONE OF THE ENGINE INDICATOR LIGHTS WAS NOT ILLUMINATED. THE CANISTER AND ASPIRATION TUBING (TUBING) WERE DISCONNECTED AND RE-CONNECTED TWICE BUT THE ISSUE DID NOT RESOLVE. IT WAS REPORTED THAT THE CANISTER LID FELT LOOSE. THEREFORE, THE CANISTER WAS REMOVED. AFTER THE CANISTER WAS RETURNED TO THE DISTRIBUTOR, IT WAS FOUND THAT THE LID WAS CRACKED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12474559 ↗
• MalfunctionSep 3, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) AND THE BASILAR ARTERY USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), A NON-PENUMBRA REVASCULARIZATION DEVICE, A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE ENGINE SOUNDED LIKE IT WAS FUNCTIONAL; HOWEVER, NONE OF THE INDICATOR LIGHTS ILLUMINATED AND NO ASPIRATION WAS BEING PRODUCED. IT WAS REPORTED THAT THE LID OF THE CANISTER AND THE ENGINE WERE CHECKED SEVERAL TIMES BUT THE ISSUE PERSISTED. THEREFORE, THE ENGINE AND THE CANISTER WERE REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SYRINGE TO PERFORM MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423807 ↗
• MalfunctionJul 21, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE CANISTER WOULD NOT PROVIDE PROPER SUCTION. THE PHYSICIAN TRIED TO TROUBLESHOOT THE PROBLEM BY CLEARING THE LINE; HOWEVER, THE CANISTER STILL WOULD NOT PROVIDE PROPER 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206905 ↗
• MalfunctionJun 18, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), ASPIRATION TUBING (TUBING), PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN ATTACHED THE CANISTER AND TURNED ON THE ENGINE; HOWEVER, THE ENGINE WAS NOT ABLE TO PRODUCE FULL ASPIRATION LEVEL. THE PHYSICIAN CHECKED TO SEE IF THE TUBING WAS PLUGGED IN AND THE LID TO THE CANISTER WAS PROPERLY SEALED. THE CANISTER WAS THEN RESEATED BUT THE SAME ISSUE OCCURRED AND, THEREFORE, IT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12028967 ↗
• MalfunctionMay 25, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE, A PENUMBRA CANISTER (CANISTER) AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE CANISTER WAS PLACED ONTO THE ENGINE AND THEN THE ACE68 WAS CONNECTED TO THE ENGINE. AFTERWARDS, ASPIRATION WAS INITIATED; HOWEVER, NOT ENOUGH VACUUM WAS OBSERVED COMING FROM THE DISTAL TIP OF THE ACE68. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER, THE SAME ENGINE, AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11874893 ↗
• MalfunctionMay 17, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER) AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, AS THE PHYSICIAN WAS ATTEMPTING THE FIRST PASS, THEY NOTICED THE CANISTER WOULD NOT BUILD VACUUM PRESSURE TO ASPIRATE. IT WAS REPORTED THAT ALL FOUR INDICATOR LIGHTS ON THE ENGINE WERE NOT ILLUMINATED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11832606 ↗
• MalfunctionMar 17, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER), ASPIRATION TUBING (TUBING) PACKAGED WITH THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) FROM A PENUMBRA SYSTEM ACE 68 KIT, PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ACE68 AND THE TUBING WERE IN USE IN THE PATIENT WHEN THE PHYSICIAN REALIZED THAT THE CANISTER WOULD NOT MAINTAIN SUCTION. THEREFORE, THE CANISTER AND TUBING WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER, NEW TUBING, THE SAME ACE68, 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 11509843 ↗
• MalfunctionJan 11, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER), A PENUMBRA ENGINE (ENGINE) AND A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE CANISTER WAS PLACED ONTO THE ENGINE AND THEN THE JET7 WAS CONNECTED TO THE ENGINE. AFTERWARDS, ASPIRATION WAS INITIATED; HOWEVER, NO ASPIRATION WAS FELT COMING FROM THE DISTAL TIP OF THE JET7. SUBSEQUENTLY, IT WAS NOTICED THAT THE CANISTER WAS NOT HOLDING PRESSURE EVEN THOUGH ALL FOUR INDICATOR LIGHTS ILLUMINATED ON THE ENGINE. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER, THE SAME ENGINE AND THE SAME JET7. 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 11152400 ↗
• MalfunctionDec 30, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A RIGHT CAROTID T OCCLUSION USING A PENUMBRA ENGINE (ENGINE) AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE CANISTER WAS PLACED ONTO THE ENGINE AND THEN THE ENGINE WAS POWERED ON. SUBSEQUENTLY, NO VACUUM WAS OBSERVED; THEREFORE, THE CANISTER WAS REMOVED AND REPLACED WITH A NEW CANISTER. AFTERWARDS, TWO PASSES WERE COMPLETED USING THE ENGINE AND THE NEW CANISTER. DURING THE THIRD PASS, IT WAS OBSERVED THAT THE ENGINE DID NOT GENERATE ANY VACUUM. THEREFORE, THE ENGINE AND CANISTER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. 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 11097865 ↗
• MalfunctionDec 29, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A RIGHT CAROTID T OCCLUSION USING A PENUMBRA ENGINE (ENGINE) AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE CANISTER WAS PLACED ONTO THE ENGINE AND THEN THE ENGINE WAS POWERED ON. SUBSEQUENTLY, NO VACUUM WAS OBSERVED; THEREFORE, THE CANISTER WAS REMOVED AND REPLACED WITH A NEW CANISTER. AFTERWARDS, TWO PASSES WERE COMPLETED USING THE ENGINE AND THE NEW CANISTER. DURING THE THIRD PASS, IT WAS OBSERVED THAT THE ENGINE DID NOT GENERATE ANY VACUUM. THEREFORE, THE ENGINE AND CANISTER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. 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 11089353 ↗
• MalfunctionNov 13, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA ENGINE CANISTER (CANISTER) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, IT WAS REPORTED THAT THE ENGINE DID NOT ASPIRATE PROPERLY AND ONLY ONE INDICATOR LIGHT WAS ILLUMINATING. THE CANISTER WAS RE-INSTALLED; HOWEVER, NO IMPROVEMENT WAS NOTED. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10834812 ↗
• MalfunctionSep 22, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM (PE) USING A PENUMBRA ENGINE (ENGINE) AND A PENUMBRA ENGINE CANISTER (CANISTER). WHILE SETTING UP FOR THE PROCEDURE, THE ENGINE WAS INADVERTENTLY DROPPED ON THE FLOOR. DURING THE PROCEDURE, WHILE THE ENGINE WAS IN USE IN THE PATIENT, IT WAS UNABLE TO REACH THE MAXIMUM VACUUM PRESSURE. IT WAS REPORTED THAT ONLY ONE TO TWO OF THE ENGINE INDICATOR LIGHTS WERE ILLUMINATING. THE PHYSICIAN POWERED THE ENGINE ON AND OFF, AND EXCHANGED THE CANISTER FOR A NEW ONE; HOWEVER, THE ISSUE PERSISTED. THEREFORE, THE ENGINE AND CANISTER WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX (PUMP MAX). 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 10567299 ↗