RED RED62S-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00815948023475), received between Jun 14, 2022 and Feb 27, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K203440); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMay 3, 2024Unraveled Material; Material Deformation; Unraveled Material; Material Deformation

  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 ACCESS CATHETER, A NON-PENUMBRA ASPIRATION CATHETER, A NON-PENUMBRA MICROCATHETER, A STENT RETRIEVER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NON-PENUMBRA ASPIRATION CATHETER AND THE STENT RETRIEVER TO THE TARGET LOCATION AND COMPLETED ONE PASS. IT WAS REPORTED THAT THE ACCESS CATHETER WAS REMOVED AT SOME POINT. THE PHYSICIAN ATTEMPTED TO COMPLETE A SECOND PASS WITHOUT SUCCESS. THE NON-PENUMBRA ASPIRATION CATHETER AND THE GUIDEWIRE WAS THEN EXCHANGED FOR A RED62 AND ANOTHER GUIDEWIRE. THE RED62 AND THE STENT RETRIEVER WERE THEN ADVANCED THROUGH THE SECOND ACCESS CATHETER TO THE TARGET LOCATION; HOWEVER, THE RED62 WAS NOT MOVING. IT WAS REPORTED THAT THE ACCESS CATHETER KICKED BACK. THE PHYSICIAN THEN REMOVED THE RED62, THE SECOND ACCESS CATHETER, THE STENT RETRIEVER, AND THE SECOND GUIDEWIRE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACCESS CATHETER WAS KINKED AT THE MIDSHAFT AND THE RED62 HAD UNRAVELED AT THE MIDSHAFT TOWARD THE PROXIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19241969 ↗
• MalfunctionApr 12, 2024Stretched; Unraveled Material; Physical Resistance/Sticking; Stretched; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT DISTAL INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND GUIDEWIRES. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RED62 TOGETHER WITH THE MICROCATHETER AND THE GUIDEWIRE THROUGH THE DISTAL END OF THE NEURON MAX DURING THE SECOND PASS. THE PHYSICIAN THEN REMOVED THE DEVICES, FLUSHED THE RED62 IN A SALINE SOLUTION, AND ATTEMPTED TO RE-ADVANCE THE RED62, MICROCATHETER, AND GUIDEWIRE TOGETHER THROUGH THE NEURON MAX. WHILE RE-ADVANCING THE DEVICES THROUGH THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN DECIDED TO REMOVE THE RED62 AND EXPERIENCED RESISTANCE RETRACTING THE DEVICES THROUGH THE NEURON MAX. THE PHYSICIAN CONTINUED REMOVING THE DEVICES AND, AFTER REMOVAL OF THE RED62, THE PHYSICIAN FOUND THAT THE DISTAL LENGTH OF THE RED62 WAS STRETCHED AND UNRAVELED. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND A STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19099348 ↗
• MalfunctionJan 2, 2024Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A BALLOON CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES IN THE TARGET LOCATION USING THE RED62. AFTER THE THIRD PASS, THE PHYSICIAN INJECTED CONTRAST THROUGH THE RED62 IN ORDER TO CHECK THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE AND NOTICED UNDER FLUOROSCOPY THAT THE RED62 WAS EXPANDED. THEREFORE, THE RED62 WAS REMOVED. THE PHYSICIAN OPENED A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND FOUND THAT THE ACE68 WAS OVALIZED AT THE DISTAL LENGTH. THE PHYSICIAN STILL ATTEMPTED TO INTRODUCE THE ACE68 THROUGH THE SAME BALLOON CATHETER WITHOUT SUCCESS. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME BALLOON CATHETER AND A NON-PENUMBRA REVASCULARIZATION DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428456 ↗
• MalfunctionDec 8, 2023Fracture; Fracture

  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 (RED62), A NON-PENUMBRA SHEATH, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT RETRIEVER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE RETRACTING THE RED62 AFTER FIRST PASS ASPIRATION, THE RED62 FRACTURED MID-SHAFT. IT WAS REPORTED THAT THE SHEATH WAS NOTICED TO BE KINKED UNDER FLUOROSCOPY. THE PHYSICIAN THEN REMOVED THE RED62 WITH THE ENTIRE SYSTEM. THE PROCEDURE ENDED AT THIS POINT. THE PHYSICIAN COULD NOT REGAIN ACCESS ONCE THE ENTIRE SYSTEM WAS REMOVED. THE PATIENT WAS PLACED ON COMFORT CARE AND EXPIRED LATER THAT DAY. THE CAUSE OF DEATH WAS RETROPERITONEAL HEMATOMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297508 ↗
• MalfunctionSep 26, 2023Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), THE MIDDLE CEREBRAL ARTERY (MCA), AND THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A NON-PENUMBRA MICROCATHETER (TREVO TRAK21). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS COMPLETING A FIRST PASS AND NOTICED THAT A SIGNIFICANT VASOSPASM HAD OCCURRED IN THE ICA AND CAUSED THE NEURON MAX AND THE RED62 TO BECOME OVALIZED AT THE DISTAL LOCATION. IT WAS REPORTED THAT THE VASOSPASM EVENT WAS NOT RESOLVED. THE PHYSICIAN THEN CONTINUED TO COMPLETE A SECOND PASS USING THE SAME RED62 AND THE SAME NEURON MAX. WHILE COMPLETING A SECOND PASS, THE PHYSICIAN NOTICED THAT THE RED62 DISTAL END WAS NOT MOVING UNDER FLUOROSCOPY. UPON RETRACTION OF THE RED62, THE PHYSICIAN NOTICED THAT THE RED62 APPEARED TO BE STRETCHED AND FRACTURED AT THE OVALIZED LOCATION. A SNARE DEVICE WAS THEN USED TO RETRIEVE THE FRACTURED DISTAL END OF THE RED62 ALONG WITH THE CLOT THAT WAS AT THE TIP OF THE RED62. THE PROCEDURE WAS COMPLETED AT THIS POINT AND COMPLETE REVASCULARIZATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819498 ↗
• MalfunctionJun 14, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BMX96 INTO THE LEFT COMMON CAROTID ARTERY, AND THEN ADVANCED THE RED62, VELOCITY, AND GUIDEWIRE THROUGH THE BMX96 AND INTO THE TARGET VESSEL. THE VELOCITY AND GUIDEWIRE WERE THEN REMOVED. WHILE RETRACTING THE RED62 TO COMPLETE THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE BMX96 MOVED INTO THE EXTERNAL CAROTID ARTERY, CAUSING FORCE ON THE RED62 AND SUBSEQUENT KINK AND BREAK OF THE RED62 SINCE IT WAS ALREADY ADVANCED INTO THE M2. IT WAS REPORTED THAT THE DISTAL 25 CENTIMETERS OF THE RED62 REMAINED IN THE PATIENT FROM THE M2 ALL THE WAY DOWN TO THE EXTERNAL CAROTID ARTERY. THE PHYSICIAN THEN USED A STENT RETRIEVER DEVICE TO PULL THE PROXIMAL END OF THE RED62 BACK INTO THE COMMON CAROTID ARTERY. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE STENT RETRIEVER DEVICE AGAINST THE RED62 TO PULL IT OUT, BUT IT ROLLED OVER T

  Patient problems: Foreign Body In Patient

  MAUDE report 14686175 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K203440. One submission often covers many models, so check the product and lot details in each record.

• Z-3331-2026 · Jul 24, 2026 · Open, Classified
  Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Pro