CEREGLIDE SBC92114UGRecalls & reported problems
Cerenovus, Inc. · CEREGLIDE 92 Catheter System CEREGLIDE 92 INNERGLIDE 9 114 cm 165 cm 0.092 in (2.34 mm) 0.030 in (0.76 mm) 0.102 in (2.59 mm) 0.042 in (1.07 mm) 0.108 in (2.74 mm) 0.078 in (1.98 mm) 0.113 in (2.87 mm) Minimum Guide Diameter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704086017), received between May 5, 2025 and May 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Crack2
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Deformation Due to Compressive Stress
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE A CEREGLIDE 92 INTERMEDIATE CATHETER (PRODUCT CODE: SBC92114UG, LOT NUMBER: 31679920) IT IN A STROKE PROCEDURE, HOWEVER THE DEVICE KINKED INSIDE THE PATIENT¿S BODY AND THE USER WAS NOT ABLE TO ADVANCE ANYTHING. HE ENDED UP PULLING IT OUT AND CHANGING SYSTEMS. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-MAY-2026 INDICATED THAT THE TARGET VESSEL WAS THE LEFT INTERNAL CAROTID ARTERY (ICA) AND LEFT M1 SEGMENT. THERE WAS NO SIGNIFICANT TORTUOSITY OR CALCIFICATION. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE. THE PHYSICIAN NOTES THAT THIS WAS A ICA AND M1 OCCLUSION, THE ARCH WAS A TYPE TWO AND A HALF, THERE WAS CALCIFIED ATHEROSCLEROSIS UP IN THE INTRACRANIAL ICA BUT NO SIGNIFICANT DISEASE AT THE BIFURCATION OR IN THE CERVICAL SEGMENT. THE USER ADVANCED THE CATHETER OVER SIX FRENCH SIM 2 OVER A STIFF GLIDE WIRE SO THAT THE USER COULD PROVIDE A GOOD STRONG SUPPORT BASE. HOWEVER, WHEN THE USER TRIED TO ADVANCE INNER CATHETER THAT COMES WITH THE CEREGLIDE, IT KEPT GETT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161083 ↗MalfunctionDec 1, 2025Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT IMMEDIATELY UPON REMOVING A CEREGLIDE CATHETER (SBC92114UG, 31608036) FROM THE HOOP, THE TECHNICIAN OBSERVED THE HUB ON THE FLUSH PORT TO BE CRACKED. THE DEVICE WAS SET ASIDE AND NEW ONE WAS USED. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-NOV-2025 INDICATED THAT THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING (I.E. CREASED, TORN). THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682502 ↗MalfunctionMay 5, 2025Crack; Crack
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN ISCHEMIC STROKE, THE CEREGLIDE 92 CATHETER SYSTEM (SBC92114UG / 31534052) WAS FLUSHED APPROPRIATELY. THE CEREGLIDE 92 AND INNERGLIDE 9 WERE INSERTED INTO THE PATIENT THROUGH AN 8F LONG GUIDE SHEATH (UNSPECIFIED BRAND). AFTER REMOVING THE INNERGLIDE 9, THE CEREGLIDE 92 WAS FLUSHED WITH SALINE, AND IT WAS REPORTED THAT ¿SALINE SQUIRTED BACK OUT FROM HUB.¿ A SMALL CRACK WAS NOTED IN THE CLEAR PLASTIC HUB PORTION OF THE CATHETER. THE SYSTEM WAS REMOVED. A NEW CEREGLIDE 92 AND INNERGLIDE 9 WERE OPENED AND USED IN THE PROCEDURE WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT. ON 05-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961766 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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