Penumbra System 5MAXJET7-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00815948020955), received between Nov 27, 2019 and Nov 11, 2020 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Dec 15, 2020Terminated

   The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.

   Z-0848-2021 · Root cause: Process design · Recall details · FDA record ↗

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.

• MalfunctionNov 11, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NON-PENUMBRA SHEATH, NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE JET7, MICROCATHETER, AND STENT RETRIEVER. THE JET7 AND STENT RETRIEVER WAS THEN REMOVED, AND THE JET7 WAS FLUSHED. NEXT, A SECOND PASS WAS MADE USING THE SAME JET7, MICROCATHETER AND A NEW STENT RETRIEVER. SUBSEQUENTLY, WHILE REMOVING THE JET7, THE PHYSICIAN NOTICED THE JET7 TO BE BROKEN APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL END. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. 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 10825975 ↗
• MalfunctionNov 6, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 OVER A GUIDEWIRE THROUGH THE NEURON MAX INTO THE TARGET VESSEL AND COMPLETED ONE PASS. WHILE ADVANCING THE JET7 FOR THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE JET7 WAS REMOVED. AFTERWARDS, THE JET7 WAS FLUSHED ON THE BACK TABLE USING A SYRINGE AND NOTICED THAT THE DISTAL TIP OF THE JET7 EXPANDED. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND THE SAME NEURON 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 10804676 ↗
• MalfunctionOct 29, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, PRIOR TO USE, THE HOSPITAL STAFF NOTICED THAT A JET7 WAS FRACTURED NEAR THE HUB AFTER REMOVAL OF THE PACKAGING. THE DAMAGE TO THE JET7 WAS FOUND PRIOR TO USE AND THEREFORE, THE JET7 WAS NOT USED IN THE PROCEDURE. A NEW JET7 WAS OPENED AND ADVANCED OVER A GUIDEWIRE THROUGH THE NEURON MAX INTO THE ICA. THE JET7 WAS THEN CONNECTED TO THE PUMP AND ASPIRATION WAS INITIATED. A PASS WAS COMPLETED USING THE JET7 AND THEN THE JET7 WAS REMOVED. AFTER THE REMOVAL, IT WAS NOTICED THAT THREE TO FOUR CENTIMETERS NEAR THE DISTAL TIP OF THE JET7 WAS DEFORMED; THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND THE SAME NEURON 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 10759849 ↗
• MalfunctionOct 29, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NON-PENUMBRA MICROCATHETER, BALLOON GUIDE CATHETER, AND SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE TARGET VESSEL VIA THE RADIAL ARTERY USING THE BALLOON GUIDE CATHETER AND SHEATH, FOLLOWED BY PERFORMING MANUAL ASPIRATION USING A SYRINGE AND THE JET7. WHILE RETRACTING THE JET7 FROM THE BALLOON GUIDE CATHETER ON THE FIRST PASS, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE, AND THE DISTAL END OF THE JET7 FRACTURED. UPON REMOVAL OF THE JET7, THE PHYSICIAN NOTICED THAT THE TIP OF THE JET7 WAS STILL INSIDE THE BALLOON GUIDE CATHETER. THEREFORE, THE BALLOON GUIDE CATHETER CONTAINING THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), NON-PENUMBRA SHEATH, AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN RE-ACCESSED THE TARGET VESSEL VIA THE FEMORAL ARTERY. 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 10759785 ↗
• MalfunctionSep 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND PENUMBRA PUMP. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 TO THE TARGET VESSEL, CONNECTED THE JET7 TO THE PUMP, AND PERFORMED ASPIRATION USING THE JET7 FOR 90 SECONDS. SUBSEQUENTLY, THE JET7 WAS REMOVED. IT WAS REPORTED THAT UPON REMOVAL, 3-4CM FROM THE TIP OF THE JET7 WAS OBSERVED TO BE DEFORMED. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522259 ↗
• MalfunctionAug 27, 2020Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 OVER THE 3MAXC AND THROUGH THE NEURON MAX TO THE TARGET VESSEL. THE PHYSICIAN THEN COMPLETED THREE PASSES USING THE JET7. AFTER THE THIRD PASS, THE JET7 WAS REMOVED AND FLUSHED ON THE BACK TABLE. AFTER FLUSHING, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE JET7 EXPANDED AND; THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER WITH THE SAME NEURON MAX AND 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462577 ↗
• MalfunctionAug 7, 2020Stretched; Suction Failure; Stretched; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX, ADVANCED THE JET7 OVER THE MICROCATHETER AND GUIDEWIRE TO THE CLOT, THEN REMOVED THE MICROCATHETER AND GUIDEWIRE. NEXT, ASPIRATION WAS INITIATED; HOWEVER, AFTER APPROXIMATELY 90 SECONDS NO FLOW BEING OBSERVED AND THE JET7 WAS REMOVED. WHILE FLUSHING THE JET7 ON THE BACK TABLE, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE JET7 EXPANDED. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER DEVICE, THE SAME NEURON MAX AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10377493 ↗
• MalfunctionMay 1, 2020Break; Suction Problem; Break; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), AND ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE JET7 TO THE ENGINE VIA THE TUBING AND PLACED THE CANISTER IN THE ENGINE. IT WAS REPORTED THAT THE TUBING AND CANISTER HAD ALREADY BEEN CHECKED. WHILE ASPIRATING THE JET7 WITH THE ENGINE IN THE TARGET VESSEL ON THE FIRST PASS, NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE WERE ILLUMINATED, AND FULL ASPIRATION WAS NOT ACHIEVED; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE JET7. UPON REMOVAL, THE DISTAL TIP OF THE JET7 WAS OBSERVED TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER JET7 AND THE SAME ENGINE, CANISTER, AND TUBING, ALONG WITH A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3 RECANALIZATION WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10017761 ↗
• MalfunctionMar 27, 2020Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PHYSICIAN BEGAN ASPIRATING WITH THE JET7 TO MAKE THE FIRST PASS AND HEARD AIR LEAKING. UPON INSPECTION OF THE JET7, THE PHYSICIAN NOTICED THAT IT WAS KINKED AND HAD A PIN-SIZE HOLE AT THE SITE OF THE KINK. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892241 ↗
• MalfunctionMar 14, 2020Stretched; Failure to Advance; Physical Resistance/Sticking; Stretched; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA GUIDING SHEATH. DURING THE PROCEDURE, THE PHYSICIAN DILATED THE RADIAL ARTERY, ADVANCED THE GUIDING SHEATH ALONG WITH THE DILATOR DIRECTLY THROUGH THE SKIN TO THE INTERNAL CAROTID ARTERY (ICA) AND THEN REMOVED THE DILATOR. WHILE ADVANCING THE JET7 AND VELOCITY THROUGH THE CHECK-FLO HEMOSTATIC VALVE ON THE GUIDING SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE JET7 WOULD NO LONGER ADVANCE; THEREFORE, IT WAS REMOVED. UPON REMOVAL OF THE JET7, IT WAS NOTICED THAT THE JET7 STRETCHED AND THE DISTAL END OF THE JET7 BROKE OFF. IT WAS REPORTED THAT THE BROKEN PIECE OF THE JET7 WAS STUCK IN THE PROXIMAL END OF THE GUIDING SHEATH WITH THE BROKEN PIECE OF THE JET7 HANGING OUT OF THE DISTAL END OF THE GUIDING SHEATH. THE PHYSICIAN THEN REMOVED THE WHOLE SYSTEM FROM THE PATIENT WITH BOTH THE GUIDING SHEATH AND REMAINING BROKEN PIECE OF THE JET7. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), SAME CHECK-FLO HEMOSTATIC VALVE AND A NEW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832928 ↗
• MalfunctionJan 6, 2020Stretched; Unraveled Material; Stretched; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) TO THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), NON-PENUMBRA STENT RETRIEVER, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 AND MICROCATHETER THROUGH THE NEURON MAX TO THE CLOT. THE MICROCATHETER WAS THEN REMOVED AND THE PHYSICIAN USED THE JET7 WITH ASPIRATION. NEXT, THE PHYSICIAN ADVANCED THE STENT RETRIEVER THROUGH THE SAME MICROCATHETER AND MADE FOUR PASSES. AFTERWARDS, WHILE RETRACTING THE STENT RETRIEVER AND MICROCATHETER AS A SYSTEM OUT OF THE JET7, IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE. THE JET7 THEN WAS REMOVED TO BE FLUSHED ON THE BACK TABLE; HOWEVER, IT WAS REPORTED THAT THE DISTAL END OF THE JET7 WAS FOUND TO BE DAMAGED. AFTER FLUSHING, THE PHYSICIAN NOTICED THE JET7 EXPANDED AND THERE WAS SOME UNWINDING OF THE COILS. THE PROCEDURE WAS THEN COMPLETED USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), THE SAME NEURON MAX, THE SAME MICROCATHETER AND ANOTHER STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9555705 ↗
• MalfunctionNov 27, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) INTO THE PATIENT¿S VESSEL, FOLLOWED BY A GUIDEWIRE, A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND THE JET7. THE GUIDEWIRE WAS THEN REMOVED, AND A NON-PENUMBRA REVASCULARIZATION DEVICE WAS ADVANCED THROUGH THE DEVICES AND INTO THE CLOT. THE VELOCITY WAS ALSO REMOVED AND ASPIRATION COMMENCED USING THE JET7 AND REVASCULARIZATION DEVICE TO BREAK UP THE CLOT. THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE RETRACTING THE REVASCULARIZATION DEVICE OUT OF THE JET7 AND REPORTED THAT IT WAS UNABLE TO BE RETRACTED FURTHER OUT OF THE JET7. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE JET7 AND REVASCULARIZATION DEVICE TOGETHER. WHILE PULLING BACK ON THE DEVICES, THE JET7 BROKE APART AT THE HUB. IT WAS REPORTED THAT THE BROKEN JET7 WAS CONNECTED BY THE UNRAVELING COIL WIND; THEREFORE, THE JET7 AND REVASCULARIZATION DEVICE WERE ABLE TO BE COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING A NEW JET7, THE SAME NEURON MAX, THE SAME VELOCITY, AND THE SAME REVASCULARIZATION DEV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9387068 ↗