CEREBASERecalls & reported problems across all models

We found 3 models of CEREBASE by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 143 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2020 and Aug 17, 2026 — classified as 3 deaths, 8 injuries, 132 malfunctions.

The most frequently reported specific device problem is “Crack” (75 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CEREBASE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 2, 2024Open, Classified

   Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

   Z-1284-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

Most reported CEREBASE problems

CEREBASE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CEREBASE GS9090SD

  Catheter, Percutaneous, Neurovasculature
  1 recall2 deaths97 reports
• CEREBASE GS9095SD

  Catheter, Percutaneous, Neurovasculature
  1 recall1 death33 reports
• CEREBASE GS9080SD

  Catheter, Percutaneous, Neurovasculature
  1 recall13 reports

Recent CEREBASE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279762 ↗
• MalfunctionAug 11, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209056 ↗
• MalfunctionJun 12, 2026Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE PROXIMAL BODY OF THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31580143) WAS KINKED WHEN THE DEVICE WAS LOCKED WITH THE Y-CONNECTOR. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 02-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE KINK OCCURRED IN PATIENT, PRIOR TO ASPIRATION OR DELIVERY THE STENT RETRIEVER. THE CEREBASE HAD TO BE REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THERE WAS NO PROCEDURE DELAY DUE TO THE ISSUE. THE ADDITIONAL INFORMATION DID NOT INCLUDE THE EVENT DATE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 12-JUN-2026. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492053 ↗
• MalfunctionMay 19, 2026Crack; Unsealed Device Packaging

  PRIOR TO THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31749653) FOR INSPECTION. THE PROXIMAL END OF THE CEREBASE CATHETER WAS FOUND CRACKED. THE DEVICE WAS NOT USED FOR THE PROCEDURE IN THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 13-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DEVICE PACKAGING IS AVAILABLE FOR RETURN. THE STERILITY SEAL WAS COMPROMISED. THE REPLACEMENT DEVICE WAS ANOTHER 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222550 ↗
• DeathApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A CEREBASE GS 90, 90 CM, STRAIGHT, DISTAL (GS9090SD/ 31817846) WAS USED FOR A BALLOON-ASSISTED COILING PROCEDURE ON TUESDAY (B)(6) 2026. ¿SHORTLY THEREAFTER, FOLLOW-UP MRI SHOWED MULTIPLE POINT EMBOLIZATION IMMEDIATELY AFTER THE PROCEDURE.¿ ON SATURDAY (B)(6) 2026, THE PATIENT¿S STATUS WAS REPORTED AS ¿GENERALIZED STATUS EPILEPTICUS ON CT SCAN, MULTIPLE HEMORRHAGES ON THE BASAL GANGLIA.¿ THE PATIENT WAS ON ANTICOAGULATION THERAPY, ELIQUIS AND ASPIRIN. ON MONDAY (B)(6) 2026, EDEMA WAS OBSERVED AND THERE WAS CONCERN FOR POSSIBLE FOREIGN BODY REACTION. MEDICATION WAS PAUSED. ON (B)(6) 2026, THE PATIENT¿S STATUS WAS REPORTED AS ¿STILL IN STATUS EPILEPTICUS, ON QUADRUPLE MEDICATION AND TRACHEOTOMIZED.¿ THE EVENT WAS REPORTED AS SUCH, ¿PATIENT WAS SCHEDULED FOR COILING. (B)(6) 2026: BALLOON-ASSISTED COILING STARTED. USED: CEREBASE, ECLIPSE, SL10 EXCELSIOR. SHORTLY THEREAFTER, FOLLOW-UP MRI WITH MULTIPLE POINT EMBOLIZATIONS IMMEDIATELY AFTER THE PROCEDURE. SATURDAY: GENERALIZED STATUS EPILEPTICUS ON CT SCAN, MULTIPLE HEMORRHAGES ON THE BASAL GANGLIA. ELIQUIS AND ASPIRIN. (B)(6) 2026: EDEMA, FOREIGN BODY REACTION? MEDICATION WAS PAUSED.

  Patient problems: Convulsion/Seizure; Foreign Body Reaction; Intracranial Hemorrhage; Swelling/ Edema; Thromboembolism

  MAUDE report 25018700 ↗
• MalfunctionApr 27, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT A CEREBASE CATHETER (PRODUCT CODE: GS9095SD, LOT NUMBER: 31736508), ¿CAME OUT OF THE PACKAGING BENT AS SOON AS IT WAS UNPACKED". THE PRODUCT WAS ONLY REMOVED, NOT INSERTED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-APR-2026 INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT. THE PRODUCT WAS ALREADY BROKEN INSIDE THE PACKAGING AND WAS ALMOST IN TWO PIECES. THERE WAS SO DAMAGE TO THE PACKAGING. THERE NO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING, THE DEVICE COULD BE REMOVED EASILY, AND THE DEFECT WAS IMMEDIATELY VISIBLE. THE CUSTOMER DISPOSED OF THE PACKAGING. THE CEREBASE WAS DAMAGED WHEN TAKEN OUT OF THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999184 ↗
• MalfunctionApr 20, 2026Crack

  IT WAS REPORTED THAT PRIOR TO THE START OF AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31811365) FOR INSPECTION. THE PROXIMAL PART OF THE CEREBASE CATHETER WAS FOUND CRACKED. IT WAS NOT USED FOR THE PROCEDURE, IN THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT FILE; THE PHOTO WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933821 ↗
• MalfunctionApr 20, 2026Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PREPPING AND FLUSHING OF A CEREBASE CATHETER (PRODUCT CODE: GS9080SD, LOT NUMBER: 31580142) THE DISTAL TIP WAS FOUND TO BE DISTORTED WITH A STRUT VISIBLE. THERE WAS NO PATIENT INJURY REPORTED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-APR-2026 INDICATED THAT THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING. THE DEVICE WILL BE RETURNED IN ITS ORIGINAL PACKAGING. THERE WAS NO BREAK IN MATERIAL INTEGRITY AT THE SITE OF THE DEFECT, SUCH AS CRACKING OR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927323 ↗
• MalfunctionApr 13, 2026Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR INSPECTION. THE PROXIMAL PART OF THE 80 CM CEREBASE DA GUIDE SHEATH (GS9080SD / 31580145) WAS FOUND CRACKED. THE DEVICE WAS NOT USED IN THE PROCEDURE, NO NEGATIVE IMPACT ON THE PATIENT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860938 ↗
• MalfunctionApr 8, 2026Component or Accessory Incompatibility

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING PROCESS OF PROCEDURE PREPARATION, THE PHYSICIAN OPENED THE DEVICE PACKAGING OF A CEREBASE STRAIGHT DISTAL CATHETER (PRODUCT CODE: GS9090SD, LOT NUMBER: 31781389) AND FOUND THE ROTATING MALE LUER CONNECTOR DOES NOT CONNECT WITH THE HEMOSTASIS VALVE FEMALE LUER. THE CEREBASE CATHETER WAS NOT USED IN THE PATIENT. A NEW CATHETER WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL EVENT INFORMATION RECEIVED ON 31-MAR-2026 INDICATED THAT THE DEVICE DID NOT APPEAR DAMAGED AT THE CONNECTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820896 ↗
• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT PRIOR TO THE START OF AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR A 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31749653) FOR INSPECTION. THE CEREBASE CATHETER WAS FOUND CRACKED. IT WAS NOT USED FOR THE PROCEDURE, IN THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT FILE; THE PHOTO WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781442 ↗
• MalfunctionMar 31, 2026Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 90 CM CEREBASE STRAIGHT DISTAL ACCESS (DA) GUIDE SHEATH (GS9090SD / 31467380) WAS DELIVERED IN PLACE AND A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31681991) WAS DELIVERED IN THE CEREBASE. THE MICROCATHETER WAS IMPEDED IN THE DISTAL END OF THE CEREBASE AND COULD NOT PASS THROUGH. THE PHYSICIAN RETRACTED THE MICROCATHETER AND REPLACED IT WITH A SECOND MICROCATHETER. THE SECOND MICROCATHETER ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN REMOVED THE SECOND MICROCATHETER AND THE CEREBASE FROM THE PATIENT AND REPLACED THE CEREBASE WITH ANOTHER CEREBASE TO DELIVER THE SECOND MICROCATHETER AND COMPLETED THE PROCEDURE, WHICH WAS REPORTEDLY PROLONGED BY ABOUT 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 31-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS NO ANOMALY OR DAMAGE NOTED ON THE FIRST MICROCATHETER. THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744439 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT A CEREBASE GS 90, 95 CM, STRAIGHT DISTAL CATHETER (PRODUCT CODE: GS9095SD, LOT NUMBER: 31756112) WAS BEING GIVEN CONTRAST, HOWEVER, IT DIDN'T REACH THE DISTAL END OF THE CEREBASE. ON IMAGING, THE USER REALIZED THAT IT WAS COMING OUT OF THE PROXIMAL END (AS WELL AS BLOOD) SLIGHTLY ABOVE THE HUB. THERE WAS A KINK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726821 ↗
• MalfunctionMar 23, 2026Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, A CEREBASE 90,60 CM STRAIGHT DISTAL CATHETER WAS DELIVERED IN PLACE. AN INTERMEDIATE CATHETER (COMPETITOR¿S BRAND) WAS ADVANCED THROUGH THE CEREBASE. AFTER PASSING THROUGH THE CEREBASE, THE INTERMEDIATE CATHETER BECAME IMPEDED AT THE DISTAL TIP OF THE CEREBASE AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN REMOVED THE CEREBASE AND INTERMEDIATE CATHETER FROM THE PATIENT. THE DISTAL TIP OF THE CEREBASE WAS OBSERVED TO BE KINKED/BENT. THE PHYSICIAN REPLACED THE DEVICES WITH A NEW CEREBASE AND A NEW INTERMEDIATE CATHETER (COMPETITOR¿S BRAND) AND COMPLETED THE PROCEDURE. THE OUTER PACKAGING AND DEVICE WERE INSPECTED PRIOR TO USE AND WERE REPORTED TO BE IN GOOD CONDITION. THERE WAS NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663977 ↗
• MalfunctionMar 18, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR INSPECTION OF A CEREBASE CATHETER. THE SHAFT OF THE CEREBASE WAS FOUND CRACKED. THE DEVICE WAS NOT USED IN PATIENT. A NEW CEREBASE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-MAR-2026 INDICATED THAT THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625768 ↗

Other Cerenovus, Inc. products

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• MICRUSFRAME47 models · 298 reports
• DELTAFILL29 models · 294 reports
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• DELTAXSFT13 models · 130 reports
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