CEREBASE GS9080SDRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886704082316), received between Oct 7, 2020 and Apr 20, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Crack” (7 reports).

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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 21, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AFTER A CEREBASE 90, 80 CM, STRAIGHT, DISTAL CATHETER (PRODUCT CODE: GS9080SD, LOT NUMBER: 31194710) WAS ADVANCED TO THE TARGET SITE, THE DOCTOR DELIVERED AN INTERMEDIATE CATHETER (OTHER BRAND) IN CEREBASE. THE INTERMEDIATE CATHETER WAS IMPEDED IN THE HUB OF CEREBASE AND COULD NOT ADVANCE ANY MORE. THE DOCTOR FOUND THAT THE SECTION NEAR CEREBASE HUB WAS KINKED/BENT. THE DOCTOR REMOVED THE CEREBASE AND THE INTERMEDIATE CATHETER FROM THE PATIENT AND SWITCHED A NEW CEREBASE TO COMPLETE THE PROCEDURE WITH THE SAME INTERMEDIATE CATHETER. THE OUTER PACKAGING AND DEVICE WERE INSPECTED AND FOUND IN GOOD CONDITION PRIOR TO THE SURGERY. ADDITIONAL EVENT INFORMATION INDICATED THAT THERE WAS NO UNDUE PROCEDURAL DELAY ASSOCIATED WITH THE EVENT THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE INTERMEDIATE CATHETER USED WAS UNOBTAINABLE. THE DEVICE DID NOT APPEAR PHYSICALLY DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT. THERE WAS NO BREAK IN MATERIAL INTEGRITY AT THE SITE OF THE DEFECT; NO CRACKING OR FRACTURE WAS OBSERVED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE BODY/SHAFT IS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134468 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE START OF A PROCEDURE, THE HUB / PROXIMAL PART OF THE 95CM CEREBASE STRAIGHT DA GUIDE SHEATH (GS9095SD / 31294739) WAS FOUND BROKEN WITH NO SIGN OF DAMAGE DURING TRANSPORTATION. THERE WAS NO IMPACT ON THE PATIENT. NO DELAY TO THE PROCEDURE. ON 29-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CEREBASE CATHETER WAS SEPARATED INTO TWO OR MORE FRAGMENTS. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 29-APR-2025, THE REPORTED EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944995 ↗
• MalfunctionMar 4, 2025Crack; Crack

  AS REPORTED BY THE FIELD, PRIOR TO USE, A CEREBASE GS 90, 80 CM, STRAIGHT, DISTAL CATHETER (GS9080SD, 31294722) WAS FOUND BROKEN IN THE PACKAGING WITH NO SIGN OF DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THERE WAS NO PROCEDURAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514325 ↗
• MalfunctionJan 3, 2025Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  AS REPORTED BY THE FIELD, THE PHYSICIAN REMOVED A CEREBASE GUIDE CATHETER DISTAL ACCESS (GS9080SD, 31403078) FROM THE PACKAGING AND TRIED TO ATTACH A VALVE TO IT BUT FOUND IT DIFFICULT TO TIGHTEN THE VALVE AROUND IT. THEN HE NOTICED A SMALL CRACK IN THE HUB OF THE CEREBASE. THE DOCTOR USED AN INFINITY GUIDE SHEATH AND FINISHED THE CASE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 24-DEC-2024 INDICATING THAT THERE WAS NO POSSIBILITY OF AIR BEING INJECTED INTO THE PATIENT. THE DEVICE HAD NOT BEEN RE-SHAPED AFTER REMOVAL FROM PACKAGING. THE PROCEDURE WAS NO DELAYED BY THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067031 ↗
• MalfunctionAug 5, 2024Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE STAFF PULLED THE 80CM CEREBASE DA GUIDE SHEATH (GS9080SD / 31294722) OUT OF THE PACKAGING, THE PROXIMAL HUB WAS DAMAGED. THE PRODUCT WAS NOT USED FOR THE PROCEDURE; THE OPERATOR ENDED UP USING A BALLAST 088 LONG SHEATH (BALT) AS A LONG GUIDE. THERE WAS NO PATIENT INVOLVEMENT; THE REPORTED ISSUE OCCURRED PRE-PROCEDURE. ON 05-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE EVENT DATE IS UNKNOWN. THE REPORTED DAMAGE WAS A HUB CRACK. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 05-AUG-2024, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907622 ↗
• MalfunctionFeb 20, 2024Material Separation; Material Separation

  AS REPORTED BY THE FIELD, A CEREBASE GUIDE CATHETER (GS9090SD, UNKNOWN LOT) WAS FOUND BROKEN IN PACKAGE UPON OPENING THE PACKAGE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740139 ↗
• MalfunctionJul 24, 2023Crack; Fluid/Blood Leak; Expiration Date Error; Crack; Fluid/Blood Leak; Expiration Date Error

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID STENT RIGHT INTERNAL CAROTID ARTERY (RICA) WITH DISTAL PROTECTION DEVICE, THE RIGHT FEMORAL ARTERY WAS ACCESSED USING AN 8 FR SHEATH AND AN 80CM CEREBASE DA GUIDE SHEATH (GS9080SD / 30702824) WITH A 5 FR. DAV CATHETER AND A GLIDEWIRE® .035 GUIDEWIRE (TERUMO) TO THE RIGHT COMMON CAROTID ARTERY (CCA) BELOW STENOSIS AND THE BIFURCATION OF THE RICA/ RIGHT EXTERNAL CAROTID ARTERY (RECA). THE CEREBASE ¿PARKED¿ AFTER PLACING IN POSITION. THE 0.5 FR. CATHETER REMOVED WITH WIRE. WHILE THE DISTAL DEVICE PROTECTION WAS BEING PREPPED, A LEAK AT THE HUB OF THE CEREBASE WAS NOTICED. AFTER LOOKING AT THE PROXIMAL END NEAR THE STRAIN RELIEF, IT WAS NOTED THAT THE CATHETER IS CRACKED. IT WAS EXCHANGED AND A 6 FR. INFINITY LONG GUIDE SHEATH WAS USED. THE CEREBASE CATHETER WAS HOOKED UP TO FLUSH THE ENTIRE TIME AND WAS PREPPED AND FLUSHED CORRECTLY. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS REPORTED TO BE DOING WELL POST-PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 10-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THIS WAS NOT A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT) PROCEDURE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381103 ↗
• MalfunctionJul 14, 2023Unsealed Device Packaging; Unsealed Device Packaging

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE SEALED BOX CONTAINING THE 80CM CEREBASE DA GUIDE SHEATH (GS9080SD / 30990130) WAS OPENED, THE PLASTIC INNER PACKAGING WAS FOUND TO BE OPEN AND THE STERILITY OF THE PRODUCT COULD NO LONGER BE GUARANTEED. IT IS, THEREFORE, NOT A COMPLAINT ABOUT THE CEREBASE PRODUCT ITSELF, BUT A COMPLAINT RELATED TO THE INNER PACKAGING OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCES / INVOLVEMENT. THE ISSUE WAS OBSERVED PRE-OP. ON 04-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DATE WHEN THE ISSUE WAS OBSERVED WAS NOT KNOWN. THERE WAS NO DAMAGE TO THE SHIPPING BOX. THERE WAS NO DAMAGE TO THE OUTER PRODUCT BOX. IT WAS NOT KNOWN IF THE SEAL OF THE INNER PACKAGE WAS OPENED OR NOT PROPERLY SEALED. THE ORIGINAL PRODUCT PACKAGE / POUCH IS NOT AVAILABLE FOR RETURN; IT WAS DISCARDED. THERE WAS NO ACTUAL DAMAGE NOTED TO THE ACTUAL PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329722 ↗
• MalfunctionMar 9, 2023Crack; Crack

  AS REPORTED BY THE FIELD, WHEN THE PHYSICIAN OPENED THE BOX OF A CEREBASE GS 90, 80 CM, STRAIGHT, DISTAL (GS9080SD, 30927835), THE CATHETER WAS BROKEN ALREADY. THE BOX DIDN'T HAVE ANY DAMAGE. THE CATHETER WASN'T USED IN THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INNER POUCH WAS SECURELY SEALED. THE DEVICE WAS STORED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512757 ↗
• MalfunctionApr 19, 2022Crack; Crack

  AS REPORTED BY THE FIELD, A CEREBASE DA GUIDE SHEATH, 80CM (GS9080SD, 30676382) WAS FOUND TO BE DAMAGED AS IT WAS BEING REMOVED FROM THE PACKAGING PRE-OP. THE PLASTIC HUB OF THE CATHETER WAS DETACHED FROM THE POLYMER JACKET OF THE CATHETER BODY. THE EVENT OCCURRED DURING STERILE PROCESSING. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE HAD BEEN ANY PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. A PICTURE OF THE DEVICE INVOLVED WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140811 ↗
• MalfunctionOct 7, 2020Fracture; Fracture

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 80CM CEREBASE DA GUIDE SHEATH (GS9080SD / 30388358) WAS OBSERVED KINKED AT THE HUB UPON REMOVAL FROM THE PACKAGING. THERE WAS NO EVIDENCE OF DEVICE CONTAMINATION. THE INNER POUCH WAS SECURE AND SEALED. NO FOREIGN MATERIAL WAS FOUND. THE ISSUE WAS DISCOVERED PRE-OP; THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT ADVERSE EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THE RETURNED DEVICE, THE DEVICE WAS OBSERVED PARTIALLY BROKEN NEAR THE ID BAND. BASED ON THE PRODUCT ANALYSIS 10/7/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10646339 ↗