Thunderbolt + RED 68 THNDRRED68KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948024373), received between Nov 14, 2022 and Jan 5, 2024 — classified as 1 death, 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K250690); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1, M2 AND M3 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA CATHETER, A NON-PENUMBRA MICROCATHETER, A STENT RETRIEVER AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE RED68. THE PHYSICIAN THEN COMPLETED A THIRD PASS USING THE RED62 AND NOTED SOME VASOSPASM AT THE PROXIMAL M2 ARTERIES. THE PATIENT WAS GIVEN 5 MG OF CARDENE INTRAARTERIALLY. POST-OP A DOBBHOFF TUBE WAS PLACED TO ADMINISTER NIMODIPINE. THE EVENT WAS CONSIDERED RESOLVED ON THE SAME DAY. IN THE 24 HR COMPUTED TOMOGRAPHY HEAD (CTH), IT WAS NOTED THAT THE PATIENT'S NIHSS SCORE INCREASED FROM 10 TO 17. IT WAS REPORTED THAT THIS 7-POINT INCREASE CAN BE ATTRIBUTED TO AN EVOLVING LEFT MCA INFARCT. STANDARD OF CARE STROKE PATHWAY WAS CONTINUED, AND THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2023. THE VASOSPASM AND EVOLVING LEFT INFARCT WERE ADJUDICATED AS ADVERSE EVENTS BY THE CEC CHAIR WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM, A POSSIBLE REL

  Patient problems: Ischemia Stroke

  MAUDE report 18460888 ↗
• DeathJul 21, 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 M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A BMX96 ACCESS SYSTEM (BMX96) A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), NON-PENUMBRA COILS, A PENUMBRA ENGINE (ENGINE), A NON-PENUMBRA ANGIOGRAPHIC CATHETER, A NON-PENUMBRA GLIDE CATHETER, A NON-PENUMBRA BALLOON CATHETER, A NON-PENUMBRA MICROCATHETER, AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN USED MULTIPLE GUIDEWIRES AND CATHETERS TO ACCESS THE TARGET VESSEL. THE PHYSICIAN COMPLETED ONE PASS USING THE RED43. AFTER COMPLETION OF THE PASS, THE RED68 WAS ADVANCED OVER THE RED43 AND GUIDEWIRE TO THE TARGET LOCATION. THE RED43 AND THE GUIDEWIRE WERE REMOVED. CYCLIC ASPIRATION WAS INITIATED FOR TWO MINUTES USING THE RED68. THE RED68 WAS REMOVED FROM THE PATIENT AND AN ANGIOGRAPHY WAS PERFORMED THROUGH THE BMX RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2A WITH SOME FAINT FILLING OF THE M1 SEGMENT AND SOME OF THE M2 TERRITORY. THEREFORE, THE PHYSICIAN ADVANCED A GUIDEWIRE FURTHER

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17374976 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MCA USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED 68). AFTER COMPLETION OF THE FIRST PASS, A SEVERE VASOSPASM OF M1 SEGMENT WAS NOTED. THE PHYSICIAN THEN ADMINISTERED 600 MG NITROGLYCERIN INTRAARTERIALLY TO TREAT THE VASOSPASM. IT WAS REPORTED THAT THE VESSEL REOCCLUDED AFTER ADMINISTERING NITROGLYCERIN WITH IN-SITE THROMBOSIS. RED68 WAS AGAIN USED TO PERFORM THROMBECTOMY. SUBSEQUENTLY, THE VASOSPASM RESOLVED WITH A CLINICAL SEQUELAE. POST PROCEDURE TICI SCORE OF 7ICI2C WAS ACHIEVED. AFTER RECOVERY, A FOLLOW-UP MRI CONDUCTED 5 HOURS POST PROCEDURE SHOWED RE-OCCLUSION OF THE LEFT M1 SEGMENT AND A LARGE MCA INFARCT. RIGHT HOMONYMOUS HEMIANOPSIA WAS ALSO REPORTED. VASOSPASM AND STROKE WERE REPORTED TO BE SERIOUS ADVERSE EVENTS WITH A POSSIBLE RELATIONSHIP TO THE INDEX STROKE, THE INDEX PROCEDURE, AND THE PENUMBRA SYSTEM. RIGHT HOMONYMOUS HEMIANOPSIA WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM, THE INDEX STROKE, AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. AS OF (B)(6) 2022 THE EVENT IS ONGOING.

  Patient problems: Ischemia Stroke; Vasoconstriction; Visual Impairment

  MAUDE report 15795057 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K250690. 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