RED 68Recalls & reported problems across all models

We found 3 models of RED 68 by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Jan 20, 2022 and Sep 15, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Fracture” (26 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

RED 68 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 3, 2026Open, Classified

   Due to manufacturing issues, reperfusion catheters may fractures

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

Most reported RED 68 problems

RED 68 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RED 68 RED68KIT-R

  Catheter, Thrombus Retriever
  1 recall31 reports
• RED 68 RED68-S

  Catheter, Thrombus Retriever
  2 reports
• RED 68 RED68KIT-A

  Catheter, Thrombus Retriever
  1 report

Recent RED 68 adverse event reports

The 15 most recent reports across all models, 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 ↗

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