REDRecalls & reported problems across all models

We found 2 models of RED by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2021 and Sep 24, 2026 — classified as 1 death, 5 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fracture” (24 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. 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

Most reported RED problems

RED models

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

• RED RED62SKIT-B

  Catheter, Thrombus Retriever
  1 death36 reports
• RED RED62S-B

  Catheter, Thrombus Retriever
  9 reports

Recent RED adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Fracture

  The patient was undergoing a thrombectomy procedure in the left M2 segment of the middle cerebral artery (MCA) using a Penumbra System RED 62 Reperfusion Catheter (RED62), a non-Penumbra guide catheter (7F), a non-Penumbra catheter (5Fr), and a non-Penumbra sheath (7Fr), and a guidewire (.035). The physician advanced the guide catheter and 5Fr catheter to the target location. The 5Fr catheter was then removed and an angiogram was performed. The physician advanced the guide catheter and 5Fr catheter to the target location and performed an angiogram after removal of the 5Fr catheter. The RED62 and guidewire were then advanced to the thrombus. Following removal of the guidewire, aspiration was initiated using a 60ml syringe and the RED62. During retraction, the RED62 was noted to be fractured while passing through the hemostasis valve. The guide catheter and RED62 were subsequently removed together from the patient.On the back table, resistance was encountered while attempting to remove the RED62 from the guide catheter. The procedure was completed with a Penumbra System RED 43 Reperfusion Catheter (RED43) and the same guide catheter. A post-procedure CT scan revealed a left-sided sub

  Patient problems: Vascular Dissection

  MAUDE report 50885578 ↗
• MalfunctionAug 14, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256346 ↗
• MalfunctionMay 5, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE INTRODUCING THE RED62 TO THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE RED62 WAS FRACTURED NEAR THE DISTAL LENGTH. THEREFORE, THE RED62 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER 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 25084312 ↗
• MalfunctionMay 5, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62) AND A GUIDING CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. WHILE ADVANCING THE RED62 IN THE GUIDING CATHETER, THE PHYSICIAN KINKED THE RED62. AS A RESULT, THE RED62 AND THE GUIDING CATHETER WERE REMOVED. IT WAS REPORTED THAT AFTER REMOVAL, A FRACTURE WAS ALSO OBSERVED ON THE DISTAL LENGTH OF THE RED62. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME GUIDING CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084179 ↗
• MalfunctionApr 22, 2026Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62) AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). THE PHYSICIAN COMPLETED ONE PASS WITH THE RED62. FOLLOWING COMPLETION OF THE PASS, THE RED62 WAS REMOVED FROM THE SHEATH. UPON REMOVAL, THE RED62 WAS NOTICED TO BE KINKED, AFTER WHICH THE RED62 FRACTURED. THE LOCATION OF THE FRACTURE IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS POINT, AND THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3 WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955714 ↗
• MalfunctionFeb 27, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NON-PENUMBRA SHEATH, AND A NON-PENUMBRA STENT RETRIEVER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN REMOVED THE RED62 AND THE STENT RETRIEVER TOGETHER AS A UNIT AND FOUND THE DISTAL END OF THE RED62 HAD FRACTURED AND WAS STUCK TO THE STENT RETRIEVER. THE PROCEDURE HAD ENDED AT THIS POINT AND THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3 WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472912 ↗
• MalfunctionFeb 3, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENTS JUNCTION OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED 62), A NON-PENUMBRA MICROCATHETER, AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE MAKING THE FIRST PASS WITH THE RED 62. THE PHYSICIAN DECIDED TO REMOVE THE RED 62 FROM THE PATIENT. AFTER REMOVAL, THE RED 62 DISTAL END WAS NOTED TO BE DAMAGED. THE ENTIRE RED 62 WAS REMOVED FROM THE PATIENT AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RED 62, THE SAME MICROCATHETER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254311 ↗
• MalfunctionAug 1, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED43 AND THE RED62 COAXIALLY TO THE TARGET LOCATION. THE PHYSICIAN COMPLETED TWO PASSES USING THE RED43. WHILE MANIPULATING THE RED62 AND RED43, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RED62 AND RED43 FRACTURED IN THE M1 SEGMENT OF THE MCA. THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE WITHOUT SUCCESS. A NON-PENUMBRA BALLOON DEVICE WAS USED TO REMOVE THE FRACTURED SEGMENTS OF THE RED62 AND RED43 FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RED62, A NEW RED43, AND THE SAME BM96 RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693148 ↗
• MalfunctionMar 19, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A BENCHMARK BMX81 ACCESS SYSTEM (BMX81), A NON-PENUMBRA SYSTEM, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, AND IT WAS NOTED THAT THERE WAS A TORTUOUS LOOP IN THE LICA. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE RIGHT RADIAL ARTERY USING THE SHEATH AND PLACED THE BMX81 LOW IN THE LICA DUE TO THE REDUNDANT LOOP. THE PHYSICIAN THEN ADVANCED THE RED62 AND THE RED43 TO THE TARGET LOCATION AND ASPIRATED FOR NINETY SECONDS. WHILE ATTEMPTING TO REMOVE THE RED62, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER MULTIPLE ATTEMPTS TO REMOVE THE RED62, THE PHYSICIAN FELT SOMETHING BREAK. THE BMX81 WAS REMOVED ALONG WITH THE RED62. AFTER RETRACTION OF THE RED62 FROM THE BMX81, THE RED62 WAS FOUND TO BE STRETCHED ON THE DISTAL LENGTH. THE PHYSICIAN THEN ADVANCED ANOTHER RED62, A NON-PENUMBRA CATHETER, AND A STENT RETRIEVER THROUGH THE SAME BMX81 TO THE TARGET LOCATION AND ASPIRATED FOR NINETY SECONDS. THE PHYSICIAN THEN REMOVED THE SECOND RED62 AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646366 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT AND M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A MICROWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE RIGHT FEMORAL ARTERY USING THE NEURON MAX. THE RED62 AND THE MICROCATHETER WERE ADVANCED OVER THE MICROWIRE THROUGH THE NEURON MAX TO THE M3 SEGMENT OF THE MCA. THE MICROCATHETER AND THE GUIDEWIRE WERE REMOVED AND THE PHYSICIAN COMPLETED TWO PASSES USING THE RED62. THE RED62 WAS RETRACTED SLOWLY UNDER ASPIRATION. AFTER REMOVAL OF THE RED62, THE PHYSICIAN PERFORMED A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND NOTICED A PERFORATION IN THE M2 SEGMENT OF THE MCA. THE PERFORATION WAS EMBOLIZED WITH COILS TO STOP THE BLEED. THE PROCEDURE WAS ABORTED AS THE PHYSICIAN DECIDED TO SACRIFICE THE MCA. THE PATIENT'S CURRENT MEDICAL STATUS IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 21141319 ↗
• MalfunctionOct 15, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED 62), A STENT RETRIEVER, A BALLOON GUIDE CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER COMPLETING THE FIRST PASS USING THE STENT RETRIEVER AND THE BALLOON GUIDE CATHETER, THE CLOT MIGRATED TO THE DISTAL M2 SEGMENT OF THE MCA. THE PHYSICIAN THEN USED THE RED 62 WITH THE SAME SHEATH TO PERFORM A DIRECT ASPIRATION PASS AND SUCCESSFULLY REMOVED THE CLOT AFTER ONE PASS. WHILE RETRACTING THE RED 62 FROM THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER REMOVING THE RED 62, THE PHYSICIAN FOUND THAT RED 62 WAS FRACTURED AT THE DISTAL LENGTH. AT THIS POINT, NO ADDITIONAL PASSES WERE REQUIRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457288 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A BMX96 ACCESS SYSTEM (BMX96), A STENT RETRIEVER, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER COMPLETING THE FIRST PASS USING THE RED62 AND THE STENT RETRIEVER, THE PHYSICIAN REMOVED BOTH DEVICES TOGETHER FROM THE PATIENT. A FLUOROSCOPY WAS PERFORMED AND REVEALED THAT THE DISTAL END OF THE RED62 WAS INSIDE THE PATIENT. THE PHYSICIAN USED A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A MICROCATHETER, AND A NON-PENUMBRA REVASCULARIZATION DEVICE TO REMOVE THE DISTAL END OF THE RED62. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346296 ↗
• MalfunctionSep 6, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62). DURING THE PROCEDURE, WHILE ATTEMPTING TO MAKE THE SECOND PASS, THE RED62 FRACTURED. THEREFORE, THE RED62 WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162947 ↗
• InjuryJun 28, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA LONG SHEATH, AN INTRA-ARTERIAL BLOOD PRESSURE MONITOR DEVICE, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS WITH A LOOP IN THE LOWER CERVICAL REGION OF THE INTERNAL CAROTID ARTERY (ICA). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE LONG SHEATH PROXIMAL TO THE LOOP IN THE ICA. THE RED62 AND THE MICROCATHETER WERE ADVANCED OVER THE GUIDEWIRE THROUGH THE SHEATH INTO THE TARGET LOCATION. THE PHYSICIAN COMPLETED ONE PASS USING THE RED62. WHILE RETRACTING THE RED62, THE PHYSICIAN NOTICED THAT THE DISTAL PART OF THE RED62 REMAINED IN THE CAROTID TERMINUS. AS THE PHYSICIAN CONTINUED TO RETRACT THE RED62, IT WAS NOTED THAT THERE WAS A WIRE BEING PULLED OUT AND THE WIRE WAS COMPLETELY REMOVED FROM THE LONG SHEATH. THE PHYSICIAN THEN NOTICED THAT THE RED62 FRACTURED AT THE DISTAL LENGTH. THE FRACTURED PORTION OF THE RED62 REMAINED IN THE VESSEL AND MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED PART OF THE RED72 USING A SNARE DEVICE (6F, 100CM

  Patient problems: Foreign Body In Patient

  MAUDE report 19639930 ↗
• MalfunctionJun 25, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT''S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RED62 OVER THE RED43, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RED62. WHILE REMOVING, THE PHYSICIAN NOTICED THAT THE RED62 WAS FRACTURED AT THE MID DISTAL LOCATION. THEREFORE, THE RED62 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RED62, THE SAME RED43, THE SAME NEURON MAX, 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 19606367 ↗

Other Penumbra, Inc. products

• RUBY Coil90 models · 2,838 reports
• Smart Coil98 models · 2,616 reports
• Penumbra System59 models · 2,164 reports · 4 recalls
• POD24 models · 1,947 reports
• Indigo System64 models · 1,873 reports
• Penumbra Coil 400120 models · 842 reports
• Lantern Delivery Catheter11 models · 817 reports
• LP Coil System38 models · 725 reports