RED 68 RED68KIT-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00815948024113), received between Mar 17, 2022 and Sep 15, 2026 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Fracture” (25 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 3, 2026Open, Classified

   Due to manufacturing issues, reperfusion catheters may fractures

   Z-2770-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777563 ↗
• MalfunctionJun 10, 2026Fracture

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. THE PHYSICIAN ADVANCED THE RED68 OVER A GUIDEWIRE AND PERFORMED ONE PASS IN THE TARGET VESSEL. ANGIOGRAM IMAGING WAS PERFORMED USING CONTRAST AND THE PHYSICIAN NOTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE RED68 WAS FRACTURED AND UNRAVELED AT THE DISTAL LENGTH AND CONNECTED BY A WIRE INSIDE THE NEURON MAX. THE PHYSICIAN WAS ABLE TO PULL THE RED68 OUT OF THE NEURON MAX BY HAND. ANOTHER ANGIOGRAM WAS PERFORMED AND NO PART OF THE RED68 REMAINED IN THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THIS DEVICE IS WITHIN SCOPE OF LOTS IDENTIFIED IN A VOLUNTARY RECALL INITIATED JUNE 3, 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465556 ↗
• MalfunctionMay 27, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A RED68 AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED68. WHILE REMOVING THE RED68 WITH THE CLOT, THE RED68 BECAME DAMAGED AT THE DISTAL END. THE RED68 WAS REMOVED IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE DEVICE WAS RETURNED AND INVESTIGATED. BASED ON THE DEVICE INVESTIGATION RESULTS, THE REPORTABILITY DETERMINATION WAS RE-ASSESSED AND DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306635 ↗
• MalfunctionMay 27, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RED68 AND THE RED43 TO THE TARGET LOCATION, SO THE RED68 AND RED43 WERE REMOVED TOGETHER. AFTER REMOVAL, THE RED68 WAS NOTICED TO BE FRACTURED AT THE DISTAL END. WHILE REMOVING THE RED43 FROM THE RED68 ON THE BACK TABLE, THE RED68 UNRAVELED AT THE FRACTURED LOCATION. THE PROCEDURE WAS COMPLETED WITH A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62) AND THE SAME RED43. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300375 ↗
• MalfunctionMay 27, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE PHYSICIAN ADVANCED THE RED68 AND RED43 OVER THE GUIDEWIRE AND INTO THE TARGET LOCATION. THE RED43 AND GUIDEWIRE WERE REMOVED. THE PHYSICIAN BEGAN ASPIRATION USING THE RED68 WHILE APPLYING A SYRINGE VACUUM TO THE SIDE PORT OF THE ROTATING HEMOSTASIS VALVE (RHV). WHILE REMOVING THE RED68 UNDER ASPIRATION, THE PHYSICIAN NOTICED THAT MULTIPLE LOCATIONS ON THE DISTAL SEGMENT OF THE RED68 WERE FRACTURED WITHIN THE RHV. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE ENTIRE FRACTURED RED68 AND RHV TOGETHER. IT WAS REPORTED THAT ASPIRATION WAS PERFORMED TO CLEAR THE LUMEN OF THE NEURON MAX. A FOLLOW UP ANGIOGRAPHY WAS PERFORMED THAT REVEALED THE VESSEL WAS OPENED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299753 ↗
• MalfunctionMay 19, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE PHYSICIAN PERFORMED ONE PASS IN THE TARGET LOCATION USING THE RED68. AFTER REMOVING THE RED68 FROM THE PATIENT, THE PHYSICIAN FOUND THAT IT WAS FRACTURED ON THE DISTAL LENGTH. THEREFORE, THE RED68 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RED68 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222812 ↗
• MalfunctionMay 18, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68). THE PHYSICIAN MADE ONE PASS AND REMOVED THE CLOT AT THE TARGET LOCATION USING THE RED68. AFTER THE PASS, WHILE REMOVING THE RED68, THE PHYSICIAN WAS EXPERIENCING RESISTANCE. UPON REMOVAL OF THE RED68 FROM THE PATIENT, THE PHYSICIAN NOTICED THE MIDSHAFT OF THE RED68 WAS FRACTURED. IT WAS REPORTED THAT WHEN THE RED68 WAS REMOVED FROM THE PATIENT, THERE WAS CLOT INSIDE THE DISTAL END. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211185 ↗
• MalfunctionMay 7, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE PHYSICIAN PERFORMED ONE PASS IN THE TARGET LOCATION USING THE RED68. AFTER REMOVING THE RED68 FROM THE PATIENT, THE PHYSICIAN FOUND THAT IT WAS KINKED ON THE DISTAL LENGTH. AT THIS POINT, THE PROCEDURE WAS CONSIDERED TO BE COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE DEVICE WAS RETURNED AND INVESTIGATED. BASED ON THE DEVICE INVESTIGATION RESULTS, THE REPORTABILITY DETERMINATION WAS RE-ASSESSED AND DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118751 ↗
• MalfunctionMay 5, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND A NON-PENUMBRA SHEATH. THE PHYSICIAN PERFORMED ONE PASS USING THE RED68. WHILE REMOVING THE RED68, THE PHYSICIAN NOTICED THAT THE RED68 WAS FRACTURED ON THE MIDSHAFT. THE ENTIRE RED68 WAS REMOVED BY HAND, AND THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084324 ↗
• MalfunctionApr 24, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PERFORMED 2 PASSES IN THE TARGET LOCATION USING THE RED68. THE PHYSICIAN DECIDED TO REMOVE THE RED68 FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE RED68 WAS FRACTURED AT DISTAL END. IT WAS NOTED THAT THE RED68 WAS REMOVED COMPLETELY FROM THE PATIENT. THEREFORE, THE RED68 WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN OPENED A NEW RED68. AFTER COMPLETING ONE PASS, THE RED68 FRACTURED AT THE DISTAL END. THE RED68 WAS REMOVED ENTIRELY. THE PROCEDURE WAS COMPLETED WITH A RED72 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990409 ↗
• MalfunctionApr 24, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PERFORMED 2 PASSES IN THE TARGET LOCATION USING THE RED68. THE PHYSICIAN DECIDED TO REMOVE THE RED68 FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE RED68 WAS FRACTURED AT DISTAL END. IT WAS NOTED THAT THE RED68 WAS REMOVED COMPLETELY FROM THE PATIENT. THEREFORE, THE RED68 WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN OPENED A NEW RED68. AFTER COMPLETING ONE PASS, THE RED68 FRACTURED AT THE DISTAL END. THE RED68 WAS REMOVED ENTIRELY. THE PROCEDURE WAS COMPLETED WITH A RED72 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990240 ↗
• MalfunctionApr 22, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE RED68 AND THEN REMOVED THE RED68 TO BE FLUSHED. WHILE RETRACTING THE RED68, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RED68 FRACTURED ON THE MIDSHAFT. THE PHYSICIAN WAS ABLE TO REMOVE THE RED68 FROM THE SHEATH BY HAND. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953455 ↗
• MalfunctionApr 17, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A NON-PENUMBRA MICROCATHETER. ONE PASS WAS COMPLETED USING THE RED68. AFTER REMOVING THE RED68 FROM THE PATIENT, THE RED68 WAS NOTICED TO BE FRACTURED NEAR THE MIDSHAFT. THERE WAS NO PORTION OF THE RED68 THAT REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918582 ↗
• MalfunctionApr 17, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA STENT RETRIEVER. ONE PASS WAS COMPLETED USING THE RED68, AND A SECOND PASS WAS COMPLETED USING THE RED68 AND THE STENT RETRIEVER. AFTER REMOVING THE RED68 FROM THE PATIENT, THE RED68 WAS NOTICED TO BE FRACTURED NEAR THE MIDSHAFT. NO PORTION OF THE RED68 REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918486 ↗
• MalfunctionApr 14, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA STENT RETRIEVER, AND THREE NON-PENUMBRA CATHETERS. THE PATIENT¿S ANATOMY WAS NOTED TO BE TORTUOUS. ONE PASS WAS PERFORMED USING THE RED68 AND THE STENT RETRIEVER. THE RED68 AND THE STENT RETRIEVER WERE WITHDRAWN TOGETHER FOLLOWING THE PASS. AFTER REMOVAL, DAMAGE DESCRIBED AS A CRACK WAS OBSERVED AT THE DISTAL END OF THE RED68. THE RED68 WAS REMOVED IN ITS ENTIRETY, AND NO FRAGMENTS REMAINED IN THE PATIENT. A NEW RED68 WAS ADVANCED THROUGH A NON-PENUMBRA CATHETER TO THE TARGET LOCATION. ONE PASS WAS COMPLETED USING THE RED68 AND THE STENT RETRIEVER. WHILE ATTEMPTING TO REMOVE THE STENT RETRIEVER, THE STENT RETRIEVER WAS STUCK AND COULD NOT BE RETRACTED INTO THE RED68. THE RED68, STENT RETRIEVER, AND NON-PENUMBRA CATHETER WERE REMOVED FROM THE PATIENT. AFTER REMOVAL, DAMAGE DESCRIBED AS A CRACK WAS OBSERVED ON THE RED68. THE RED68 WAS REMOVED IN ITS ENTIRETY, AND NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RED68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877593 ↗
• MalfunctionApr 14, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA STENT RETRIEVER, AND THREE NON-PENUMBRA CATHETERS. THE PATIENT¿S ANATOMY WAS NOTED TO BE TORTUOUS. ONE PASS WAS PERFORMED USING THE RED68 AND THE STENT RETRIEVER. THE RED68 AND THE STENT RETRIEVER WERE WITHDRAWN TOGETHER FOLLOWING THE PASS. AFTER REMOVAL, DAMAGE DESCRIBED AS A CRACK WAS OBSERVED AT THE DISTAL END OF THE RED68. THE RED68 WAS REMOVED IN ITS ENTIRETY, AND NO FRAGMENTS REMAINED IN THE PATIENT. A NEW RED68 WAS ADVANCED THROUGH A NON-PENUMBRA CATHETER TO THE TARGET LOCATION. ONE PASS WAS COMPLETED USING THE RED68 AND THE STENT RETRIEVER. WHILE ATTEMPTING TO REMOVE THE STENT RETRIEVER, THE STENT RETRIEVER WAS STUCK AND COULD NOT BE RETRACTED INTO THE RED68. THE RED68, STENT RETRIEVER, AND NON-PENUMBRA CATHETER WERE REMOVED FROM THE PATIENT. AFTER REMOVAL, DAMAGE DESCRIBED AS A CRACK WAS OBSERVED ON THE RED68. THE RED68 WAS REMOVED IN ITS ENTIRETY, AND NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RED68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877523 ↗
• MalfunctionApr 14, 2026Fracture

  THE PATIENT WAS UNDERGOING AN ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68). THE RED68 WAS USED TO DELIVER TISSUE PLASMINOGEN ACTIVATOR (TPA) TO THE TARGET LOCATION AND THE VESSEL BECAME PATENT. NO FURTHER TREATMENT WAS NECESSARY AND THEREFORE, THE RED68 WAS REMOVED. AFTER REMOVAL, THE DISTAL LENGTH OF THE RED68 WAS FOUND TO BE FRACTURED. AT THIS POINT, THE PROCEDURE WAS CONSIDERED TO BE COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874617 ↗
• MalfunctionApr 12, 2026Crack

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NEURON MAX 6F 088 LONG SHEATH, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA STENT RETRIEVER. RADIAL ACCESS WAS USED FOR THE PROCEDURE AND THERE WAS A TIGHT TURN IN THE ANATOMY. ONE PASS WAS COMPLETED USING THE RED68 AND THE STENT RETRIEVER. AFTER THE RED68 WAS REMOVED FROM THE PATIENT, DAMAGE DESCRIBED AS A CRACK WAS OBSERVED ON THE RED68 AT THE MIDSHAFT AND THE DISTAL END. THE RED68 WAS REMOVED IN ITS ENTIRETY, AND NO FRAGMENTS REMAINED INSIDE THE PATIENT. IT WAS REPORTED THAT THE NON-PENUMBRA CATHETER WAS ALSO NOTICED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING A NEW RED68. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852990 ↗
• MalfunctionApr 10, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NEURON MAX 6F 088 LONG SHEATH, AND A NON-PENUMBRA STENT RETRIEVER. ONE PASS WAS PERFORMED USING THE RED68 AND THE STENT RETRIEVER. THE RED68 AND THE STENT RETRIEVER WERE WITHDRAWN TOGETHER FOLLOWING THE PASS. UPON REMOVAL, IT WAS REPORTED THAT THE RED68 CATHETER WAS FRACTURED. THE FRACTURED SEGMENTS REMAINED SECURED BY THE STENT RETRIEVER DURING WITHDRAWAL. ALL SEGMENTS OF THE RED68 CATHETER WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839750 ↗
• MalfunctionApr 9, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43/62/68/72 REPERFUSION CATHETER (RED43, RED62, RED68, RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A MICROWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RED43 WITH A RED72, RED62, AND A MICROWIRE, HOWEVER, THE DEVICES COULD NOT BE ADVANCED DUE TO THE PATIENT¿S ANATOMY. THE PHYSICIAN THEN ATTEMPTED TO READVANCE THE RED43 WITH A RED68 TO THE TARGET LOCATION, BUT THE RED68 AND THE RED43 WOULD NOT ADVANCE. THE PHYSICIAN DECIDED TO REMOVE THE CATHETERS BY REMOVING THE RED43 FIRST. WHILE REMOVING THE RED68, IT FRACTURED AT THE DISTAL END. THE PHYSICIAN THEN REMOVED THE RED68 BY HAND. NO PORTION OF THE RED68 WAS IN THE PATIENT'S BODY. THE PHYSICIAN ATTEMPTED TO USE NON-PENUMBRA CATHETERS; HOWEVER, THE CATHETERS WOULD NOT ADVANCE DUE TO THE PATIENT¿S ANATOMY. THE PROCEDURE WAS ABORTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837562 ↗
• MalfunctionApr 1, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A NON-PENUMBRA MICROCATHETER, A GUIDE SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED68 WITH THE MICROCATHETER AND GUIDEWIRE. UPON REACHING THE TARGET ARTERY, THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTICED THAT THE RED68 COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN REMOVED THE RED68, MICROCATHETER, AND GUIDEWIRE TOGETHER AND FOUND THE RED68 TO BE FRACTURED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24759930 ↗
• MalfunctionMar 13, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED68. AFTER COMPLETION OF THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE RED68 WAS FRACTURED UPON REMOVAL. THE RED68 WAS REMOVED BY HAND. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597801 ↗
• MalfunctionMar 13, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AN ASPIRATION TUBING (TUBING), AND A GUIDEWIRE. WHILE COMPLETING THE FIRST PASS, THE PHYSICIAN REPORTED THAT THERE WAS NO BLOOD FLOW IN THE TUBING. ALL CONNECTIONS WERE TIGHT AND NO DAMAGE WAS OBSERVED ON THE TUBING AND THE ROTATING HEMOSTASIS VALVE (RHV). THE RED68 WAS REMOVED. AFTER REMOVAL OF THE RED68, THE HOSPITAL STAFF NOTICED THAT THE RED68 WAS FRACTURED. THE RED68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), THE SAME BMX96, THE SAME TUBING, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590547 ↗
• MalfunctionFeb 19, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND THE PATIENT HAD INTRACRANIAL ATHEROSCLEROSIS (ICAS). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED68. IT WAS REPORTED THAT ALL OF THE THROMBUS WAS SUCCESSFULLY REMOVED. WHILE REMOVING THE RED68, THE MIDSHAFT OF THE RED68 WAS NOTICED TO BE FRACTURED. THE RED68 WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24396962 ↗
• MalfunctionFeb 19, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN USED THE VELOCITY TO DELIVER THE RED68 TO THE TARGET LOCATION AND SUBSEQUENTLY REMOVED THE VELOCITY. AFTER COMPLETING THE SECOND PASS USING THE RED68, THE PHYSICIAN NOTED THAT NO CLOT WAS BEING ASPIRATED. THE PHYSICIAN THEN DECIDED TO REMOVE THE RED68. THE PHYSICIAN FOUND THE RED68 FRACTURED UPON REMOVAL. THE ENTIRE RED68 WAS REMOVED BY HAND. THE RED68 AND THE VELOCITY WERE NO LONGER USED IN THE PROCEDURE. THERE WAS NO REPORTED ISSUE WITH THE VELOCITY. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395082 ↗