RED RED62SKIT-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00815948023536), received between Oct 8, 2021 and Sep 24, 2026 — classified as 1 death, 5 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 25 most recent of 36 reports, 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 ↗
• 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 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 ↗
• MalfunctionMay 24, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  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 PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES IN THE TARGET VESSEL USING THE RED62. WHILE RETRACTING THE RED62, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON REMOVAL OF THE RED62, THE PHYSICIAN NOTICED THAT THE DISTAL LENGTH OF THE RED62 WAS UNRAVELED. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE THROMBUS WITH THE RED43, HOWEVER, THE OCCLUSION COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT AFTER ACHIEVING THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2A. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392741 ↗
• MalfunctionMay 2, 2024Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF MIDDLE CEREBRAL ARTERY (MCA) THE USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A STENT RETRIEVER. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE RED62. AFTER TAKING AN IMAGE, THE PHYSICIAN ADVANCED A STENT RETRIEVER TO THE TARGET VESSEL AND COMPLETED A SECOND PASS. AFTER RETRACTING THE STENT RETRIEVER THROUGH THE RED62, THE PHYSICIAN NOTICED THAT THE RED62 WAS LEAKING FROM PROXIMAL END OF THE RED62, NEAR THE HUB. 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 19235339 ↗
• MalfunctionJan 9, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA BALLOON GUIDE CATHETER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE BALLOON GUIDE CATHETER WAS UNABLE TO ADVANCE TO THE TARGET LOCATION. DURING THE PROCEDURE, AFTER COMPLETING THREE PASSES USING THE RED62, THE PHYSICIAN REMOVED THE RED62 FROM THE PATIENT¿S BODY AGAINST RESISTANCE. AFTER REMOVAL, THE RED62 WAS NOTICED TO BE FRACTURED NEAR THE HUB. THEREFORE, THE RED62 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), THE SAME VELOCITY, AND THE SAME BALLOON GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479793 ↗
• MalfunctionDec 8, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62) AND A NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, WHILE RETRACTING THE RED62 AFTER COMPLETING THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE GUIDE SHEATH AND THE RED62 WERE REMOVED TOGETHER. THE PHYSICIAN THEN REMOVED THE RED62 FROM THE GUIDE SHEATH ON THE BACK TABLE AND NOTICED THAT THE RED62 WAS SEPARATED AT THE MID-SHAFT. IT WAS REPORTED THAT THE RED62 WAS SEPARATED BUT REMAINED CONNECTED BY THE COIL WIND. THE PROCEDURE WAS COMPLETED USING A NEW RED62 AND A NEW GUIDE SHEATH. 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 18297505 ↗
• MalfunctionNov 22, 2023Break; Unraveled Material; Break; Unraveled Material

  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 BENCHMARK BMX81 ACCESS SYSTEM (BMX81). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE REMOVING THE RED62 AFTER COMPLETING THE FIRST PASS, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RED62 HAD STARTED TO UNRAVEL. THEREFORE, THE PHYSICIAN PULLED THE BMX81 AND RED62 TOGETHER FROM THE PATIENT. THE PROCEDURE WAS 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 18196298 ↗
• MalfunctionAug 11, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A STENT RETRIEVER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE STENT RETRIEVER USING THE VELOCITY AND THE RED62 TO THE TARGET LOCATION. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE AND THE VELOCITY AND TRAPPED THE CLOT INSIDE THE STENT RETRIEVER. IT WAS REPORTED THAT THE PHYSICIAN CORKED THE STENT RETRIEVER OUTSIDE THE RED62 AND THEN REMOVED THE STENT RETRIEVER AND THE RED62 TOGETHER. UPON REMOVAL, THE DISTAL END OF THE RED62 WAS NOTICED TO BE FRACTURED BUT REMAINED CONNECTED. THE PROCEDURE WAS COMPLETED AT THIS POINT AND THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3 WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17514430 ↗
• MalfunctionJul 17, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  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), A BENCHMARK BMX 81 ACCESS SYSTEM (BMX81) AND NON -PENUMBRA STENT RETRIEVERS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED FOUR PASSES USING THE RED62 WITH THE STENT RETRIEVERS. SUBSEQUENTLY, WHILE RETRACTING THE RED62 INTO THE BMX81, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO MANIPULATE THE RED62 TO RELIEVE THE TENSION BUT WAS UNSUCCESSFUL. THEREFORE, THE RED62 AND THE BMX81 WERE REMOVED TOGETHER. UPON REMOVAL, THE RED62 WAS NOTICED TO BE STRETCHED, UNWOUND, AND FRAYED FROM THE MID-SHAFT TO THE DISTAL END. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO USE A NEW BMX81 AS A PRECAUTION, THERE WAS NO NOTICEABLE DAMAGE TO THE BMX81. THE PROCEDURE WAS COMPLETED USING A NEW RED62 AND A NEW BMX81. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333728 ↗
• MalfunctionApr 27, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  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), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS USING THE NEURON MAX AND THEN ADVANCED THE RED62 AND VELOCITY TO THE FACE OF THE CLOT. NEXT, THE PHYSICIAN ATTEMPTED TO REMOVE THE VELOCITY OUT FROM THE RED62 TO INITIATE ASPIRATION; HOWEVER, THE VELOCITY WAS STUCK AND COULD NOT BE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE RED62 AND VELOCITY TOGETHER, BUT BOTH DEVICES WERE STUCK. CONSEQUENTLY, THE PHYSICIAN CONTINUED TO PULL ON THE RED62 AND BROKE IT IN HALF. IT WAS REPORTED THAT THE ONLY HALF OF THE BROKEN RED62 WAS REMOVED ALONG WITH THE ENTIRE VELOCITY. THEREFORE, THE PHYSICIAN ADVANCED THE NEURON MAX OVER THE OTHER BROKEN HALF OF THE RED62 AND REMOVED BOTH THE RED62 AND NEURON MAX TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW ASPIRATION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828494 ↗
• MalfunctionApr 20, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA GUIDE CATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RED62 AND THE VELOCITY THROUGH THE GUIDE CATHETER TO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RED62 AND THE VELOCITY WERE REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THE RED62 AND THE VELOCITY TO BE KINKED. IT WAS REPORTED THAT THE GUIDE CATHETER BECAME OVALIZED DUE TO TORTUOSITY OF THE PATIENT''S VESSELS. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT COULD NOT BE TREATED DUE TO EXTREMELY TORTUOUS ANATOMY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16779178 ↗
• MalfunctionMar 21, 2023Break; Stretched; Break; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 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 COMPLETED ONE PASS SUCCESSFULLY USING THE RED62, VELOCITY AND A GUIDEWIRE. NEXT, UPON REMOVAL, THE PHYSICIAN STRETCHED AND FRACTURED THE RED62. THE THROMBECTOMY 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 16588449 ↗
• MalfunctionMar 21, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY TREATED M1 USING THE RED62 AND COMPLETED A PASS IN THE M2 SEGMENT. THE RED62 WAS THEN REMOVED AND FLUSHED. NEXT, WHILE ATTEMPTING TO ADVANCE THE RED62 FOR THE SECOND PASS, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RED62. WHILE RETRACTING THE RED62, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY REMOVED THE RED62 ALONG WITH THE SHEATH. IT WAS REPORTED THAT THE RED62 WAS NOTICED TO BE STRETCHED AND BROKEN AT THE MID-SHAFT. 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 16587910 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 OVER A 3MAXC AND GUIDEWIRE THROUGH A NEURON MAX AND INTO THE M1 SEGMENT OF THE MCA. THE 3MAXC WAS THEN REMOVED AND THE PHYSICIAN MADE A TOTAL OF FIVE PASSES USING THE RED72. THE RED72 WAS THEN REMOVED, AND IT WAS REPORTED THAT VASOSPASM IN THE RIGHT ICA WAS NOTED. THE VASOSPASM WAS TREATED WITH 10 MG OF VERAPAMIL OVER ONE MINUTE SPAN INTO THE RIGHT ICA. THE PHYSICIAN PERFORMED REPEATED ANGIOGRAPHY OF THE RIGHT CAROTID CIRCULATION THAT REVEALED INTERVAL WORSENING OF IRREGULARITY WITHIN THE RIGHT M1 SEGMENT. SUBSEQUENTLY, THE PHYSICIAN MADE TWO PASSES IN THE RIGHT MCA AND RIGHT M2 SEGMENT USING THE RED62; HOWEVER, THE M1 AND M2 SEGMENT WOULD INTERMITTENTLY REOCCLUDE. THE PHYSICIAN THEN ADMINISTERED 10 MG OF VERAPAMIL INTO THE RIGHT M1 SEGMENT OVER ONE MINUTE SPAN THAT RESULTED IN STABLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vasoconstriction

  MAUDE report 16573128 ↗
• MalfunctionJan 27, 2023Stretched; Unraveled Material; Stretched; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TRANSVERSE SINUS USING A RED 62 REPERFUSION CATHETER (RED62), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED62 AND MICROCATHETER OVER THE GUIDEWIRE AND THROUGH THE NEURON MAX AND COMPLETED THREE PASSES. AFTER COMPLETION OF THE THIRD PASS, THE PHYSICIAN, DECIDED TO REMOVE THE RED62 IN ORDER TO PLACE A STENT. WHILE ATTEMPTING TO REMOVE THE RED62, PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE RED62 BECAME STRETCHED AND UNRAVELED. SUBSEQUENTLY, THE RED62, MICROCATHETER, AND GUIDEWIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A STENT, THE SAME NEURON MAX, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16260334 ↗

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