Thunderbolt + RED 62 THNDRRED62SKIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948024359), received between Apr 3, 2023 and Jan 10, 2024 — classified as 1 death, 3 injuries.

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 24, 2026Open, Classified

   Due to manufacturing issues reperfusion catheters may fracture.

   Z-3331-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJan 10, 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 ANTERIOR CIRCULATION OF THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NEURON SELECT CATHETER 5F (5F SELECT), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT RECEIVED 18 MG OF THROMBOLYTIC THERAPY AND SINGLE ANTIPLATELET MEDICATION PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE LEFT M2 SEGMENT USING THE RED62. THE RED62 WAS RETRACTED TO PERFORM AN ANGIOGRAM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). ADDITIONAL CLOT WAS NOTICED IN THE RIGHT PERICALLOSAL ARTERY. THE PHYSICIAN THEN ADVANCED A RED43 INTO THE DISTAL RIGHT ANTERIOR CEREBRAL ARTERY (ACA) AND INTO THE RIGHT PERICALLOSAL ARTERY AND COMPLETED ONE PASS USING THE RED43. THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 WAS ACHIEVED. POST-THROMBECTOMY, IT WAS REPORTED THE PATIENT CONTINUED TO HAVE PE

  Patient problems: Cerebral Edema; Ischemia Stroke

  MAUDE report 18481441 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). ON (B)(6) 2023, 24 HR FOLLOW-UP COMPUTED TOMOGRAPHY (CT) DEMONSTRATED A SMALL-VOLUME SUBARACHNOID HEMORRHAGE PRESENT IN THE LEFT SYLVIAN FISSURE. THE SUBARACHNOID HEMORRHAGE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS CONSIDERED ONGOING. ON (B)(6) 2023, AN UPDATE WAS RECEIVED INDICATING THAT THE EVENT WAS RESOLVED AS THE PATIENT STARTED COUMADIN.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17012926 ↗
• InjuryApr 30, 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 M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PATIENT SUFFERED A VESSEL RUPTURE AFTER THE COMPLETION OF THE FIRST PASS. THEREFORE, THE VESSEL WAS TAMPONADED WITH A BALLOON; HOWEVER, THE EXTRAVASATION CONTINUED. THEREFORE, A COIL OCCLUSION WAS PERFORMED AND THE EVENT WAS CONSIDERED RESOLVED. THE VESSEL RUPTURE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE. ON 22-DEC-2022, AN UPDATE WAS RECEIVED FROM THE SITE INDICATING THAT THE VESSEL RUPTURE WAS UNRELATED TO THE PENUMBRA SYSTEM. ON 04-APR-2023, ADDITIONAL INFORMATION INDICATED THAT THE CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATED THAT THE VESSEL RUPTURE WAS DEFINITELY RELATED TO THE PENUMBRA SYSTEM AND THE INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 16841288 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 , THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT M2 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) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, ONE PASS WAS COMPLETED WITH MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI3). POST PROCEDURE, ON (B)(6) 2022 , MRI OF THE BRAIN SHOWED EVIDENCE OF INFARCTS THROUGHOUT THE RIGHT MCA DISTRIBUTION INVOLVING MOSTLY THE RIGHT FRONTAL LOBE AND RIGHT BASAL GANGLIA MOVEMENT AS WELL. THERE WERE ALSO INFARCTS PRESENT IN THE RIGHT MCA DISTRIBUTION. ON (B)(6) 2022 , THE PATIENT WAS DISCHARGED TO SKILLED NURSING FACILITY. MEDICATION ELIQUIS 5 MG TWICE DAILY WAS STARTED FROM (B)(6) 2022 AND THE PATIENT WAS CONTINUED ON ASPIRIN DAILY. IT WAS REPORTED THAT THE EVENT WAS UNRESOLVED AT TIME OF STUDY EXIT OR DEATH DUE TO A DIFFERENT EVENT. ON (B)(6) 2023, IT WAS REPORTED THAT THE CEC CHAIR ADJUDICATED INFARCTS POST PROCEDURE TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE, A POSSIBLE RELATIONSHIP TO THE INDEX STROKE AND A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM.

  Patient problems: Thromboembolism

  MAUDE report 16661137 ↗