Thunderbolt + RED 72 THNDRRED72KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815948024380), received between May 12, 2023 and Sep 29, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Intracranial Hemorrhage

  MAUDE report 50933823 ↗
• InjuryOct 12, 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 MIDDLE CEREBRAL ARTERY (MCA) AND INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE RED72 WAS ADVANCED TO THE ANTERIOR M2 BRANCH OF THE MCA. ASPIRATION WAS PERFORMED USING THE RED72 UNDER DIRECT FLUOROSCOPY. A FOLLOW-UP ANGIOGRAPHY REVEALED RECANALIZATION OF THE M2; HOWEVER, EXTENSIVE NONOCCLUSIVE THROMBUS WAS NOTED THROUGHOUT THE PETROUS AND CAVERNOUS ICA SEGMENTS. THE RED72 WAS THEN NAVIGATED TO THE PROXIMAL PETROUS ICA SEGMENT TO PERFORM ADDITIONAL ASPIRATION. A FOLLOW-UP ANGIOGRAPHY DEMONSTRATED COMPLETE RECANALIZATION OF THE PETROUS CAVERNOUS ICA SEGMENTS. MODERATE VASOSPASM WAS NOTED IN THE CERVICAL ICA, THE PROXIMAL M1 AND THE ANTERIOR M2. TO TREAT THE VASOSPASM, 10MG OF VERAPAMIL WAS ADMINISTERED. FURTHER ANGIOGRAPHIC EVALUATION DEMONSTRATED NONOCCLUSIVE THROMBUS IN THE M2. NEXT, THE NEURON MAX WAS PLACED IN THE PROXIMAL LEFT ICA AND THE RED62 WAS ADVANCED TO THE ANTERIOR M2, AND CONTINUOUS ASPIRATION WAS PERFORMED UNDER FLUOROSCOPY. A FOLLOW-ANGIOG

  Patient problems: Vasoconstriction

  MAUDE report 17924424 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE RED72. AFTER THE SECOND PASS, AN ANGIOGRAPHY WAS PERFORMED THAT REVEALED SLOW ANTEGRADE FLOW THROUGH THE DISTAL MCA WITH UNDERLYING LUMINAL NARROWING SECONDARY TO A VASOSPASM. THEREFORE, THE PHYSICIAN ADMINISTERED 5MG OF INTRA-ARTERIAL VERAPAMIL INTO THE DISTAL RIGHT INTERNAL CAROTID ARTERY (ICA) AND RIGHT M1 ORIGIN. THE RED72 WAS THEN REMOVED AND A RED62 WAS ADVANCED OVER THE GUIDEWIRE TO MAKE THE THIRD PASS IN THE DISTAL M1. SUBSEQUENT CONTROLLED ANGIOGRAPHY REVEALED RECANALIZATION OF THE RIGHT MCA WITH SLOW FLOW IN THE DISTAL BRANCHES. IT WAS REPORTED THE APPEARANCE OF THE BIFURCATION IS CONCERNING FOR UNDERLYING ANTHEROSCLEROTIC CHANGE WITH SUPERIMPOSED VASOSPASM. THEREFORE, THE PHYSICIAN INFUSED ADDITIONAL 5MG OF VERAPAMIL. AFTERWARDS, THE PHYSICIAN NOTICED UNDER ANGIOGRAPHY WORSENING APPEARANCE T

  Patient problems: Ischemia Stroke; Vasoconstriction

  MAUDE report 17114034 ↗
• InjuryMay 12, 2023Adverse 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 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), AND A NON-PENUMBRA COAXIAL CATHETER. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES IN THE TARGET LOCATION. WHILE ATTEMPTING TO MAKE THE FOURTH PASS, THE PHYSICIAN NOTICED THE PARTIAL DIVISION IN THE MIDDLE CEREBRAL ARTERY (MCA) IS IRREGULAR AND NARROW AT ITS ORIGIN. SUBSEQUENTLY, A VASOSPASM HAD OCCURRED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN INFUSED 10MG OF INTRA-ARTERIAL VERAPAMIL INTO THE RIGHT ICA OVER A TWO-MINUTE PERIOD. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY WITH THE INFUSION OF VERAPAMIL. THE VASOSPASM WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72) AND INDEX PROCEDURE. ON 07 JULY 23, AN UPDATE WAS RECEIVED INDICATING THAT THE VASOSPASM IS UNRELATED TO THE RED72.

  Patient problems: Vasoconstriction

  MAUDE report 16924430 ↗

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