Penumbra System PMXENGNRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00815948020030), received between Jan 19, 2021 and Nov 18, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BILATERAL FEMORAL AND ILIAC ARTERIES AND INFERIOR VENA CAVA USING A PENUMBRA ENGINE (ENGINE), LIGHTNING ASPIRATION TUBING (LIGHTNING), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ASPIRATED SOME CLOT IN THE TARGET VESSEL USING THE ENGINE AND LIGHTNING. SUBSEQUENTLY, THE PHYSICIAN TURNED OFF THE ENGINE TO USE BALLOON MACERATION. UPON TURNING THE ENGINE BACK ON, THE INDICATOR LIGHT ON THE LIGHTNING UNIT FAILED TO ILLUMINATE. TO TROUBLESHOOT, THE LIGHTNING WAS UNPLUGGED FROM THE ENGINE AND RE-PLUGGED, AND THE ENGINE WAS UNPLUGGED FROM THE POWER OUTLET AND RE-PLUGGED; HOWEVER, THE ISSUE WAS NOT RESOLVED. IT WAS REPORTED THAT A NEW LIGHTNING WAS PLUGGED INTO THE ENGINE, AND IT ALSO FAILED TO ILLUMINATE. THEREFORE, THE ENGINE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ENGINE AND THE SAME LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840808 ↗
• MalfunctionSep 29, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT12 PROXIMAL TO THE CLOT IN THE TARGET VESSEL, WHEN THE PHYSICIAN PLUGGED THE LIGHTNING UNIT INTO THE USB PORT ON THE BACK OF THE ENGINE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT BRIEFLY POWERED ON WITH THE GREEN INDICATOR LIGHT AND THEN TURNED OFF. THE ENGINE WOULD POWER ON WITH ALL FOUR INDICATOR LIGHTS ILLUMINATED; HOWEVER, THERE WAS NO ASPIRATION AT THE TIP OF THE CAT12 OR THE TUBING. IT WAS ALSO REPORTED THAT WHEN THE HOSPITAL STAFF REMOVED THE LIGHTNING FROM THE CANISTER, THE CANISTER WAS ABLE TO BUILD PRESSURE. THE HOSPITAL STAFF ALSO MADE MULTIPLE ATTEMPTS TO DISCONNECT AND RECONNECT THE LIGHTNING UNIT INTO THE USB PORT ON THE ENGINE TO TROUBLESHOOT; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE LIGHTNING WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO USE TWO NEW LIGHTNINGS WITH A NEW CAT12, A NEW CAT8, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550945 ↗
• MalfunctionJul 27, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC VEIN USING A PENUMBRA ENGINE (ENGINE) AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF PLACED THE CANISTER ONTO THE ENGINE AND NOTICED THAT ONLY THREE OF THE FOUR INDICATOR LIGHTS AROUND THE POWER BUTTON ON THE ENGINE WERE ILLUMINATED WHEN THE ENGINE WAS POWERED ON. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE THE ENGINE AND CANISTER TO ASPIRATE; HOWEVER, AFTER A FEW MINUTES, THE PHYSICIAN NOTICED THAT THE ENGINE WAS NOT PRODUCING ADEQUATE ASPIRATION. TO TROUBLESHOOT, THE HOSPITAL STAFF REMOVED THE CANISTER, INSPECTED THE LID OF THE CANISTER, AND PLACED IT BACK ONTO THE ENGINE; HOWEVER, IT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE HOSPITAL STAFF OPENED A NEW CANISTER AND PLACED IT ONTO THE ENGINE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE ENGINE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER ENGINE AND THE NEW CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. AFTER THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PENUMBRA SALES REPRESENTATIVE RECONNECTED THE FIRST CANISTER TO THE FIRST ENGINE; HOWEVER, THE SAME IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229557 ↗
• MalfunctionMay 10, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) 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. HOWEVER, NO VACUUM WAS ACHIEVED. IT WAS REPORTED THAT NONE OF THE INDICATOR LIGHTS ON THE ENGINE TURNED ON AND THAT NO SUCTION WAS GENERATED UNLESS THE HOSPITAL TECHNOLOGIST HELD THE CANISTER DOWN; THEREFORE, THE ENGINE WAS DISCONNECTED, AND THE CANISTER WAS REMOVED FROM THE ENGINE. THE PROCEDURE WAS COMPLETED USING THE SAME CANISTER AND A SECOND ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. AFTER THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PHYSICIAN ATTEMPTED TO CONNECT ANOTHER CANISTER TO THE FIRST ENGINE; HOWEVER, THE CANISTER WOULD NOT SEAT PROPERLY ONTO THE FIRST ENGINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801810 ↗
• MalfunctionJan 19, 2021Suction Problem; Suction 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 11191339 ↗