CEREGLIDERecalls & reported problems across all models

We found 6 models of CEREGLIDE by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2023 and May 13, 2026 — classified as 1 death, 25 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (17 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. 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

Most reported CEREGLIDE problems

CEREGLIDE models

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

• CEREGLIDE NIC71132U

  CATHETER, THROMBUS RETRIEVER
  1 death48 reports
• CEREGLIDE SBC92122UG

  Catheter, Percutaneous, Neurovasculature
  9 reports
• CEREGLIDE NIC71125U

  CATHETER, THROMBUS RETRIEVER
  6 reports
• CEREGLIDE NIC71137U

  Catheter, Percutaneous, Neurovasculature
  3 reports
• CEREGLIDE SBC92114UG

  Catheter, Percutaneous, Neurovasculature
  3 reports
• CEREGLIDE NIC57137U

  CATHETER, THROMBUS RETRIEVER
  1 report

Recent CEREGLIDE adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMay 5, 2026Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STROKE PROCEDURE, THE PHYSICIAN USED A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31668075) THROUGH A ZOOM¿88 ASPIRATION CATHETER (IMPERATIVE CARE). BOTH CATHETERS WERE WELL-HYDRATED (FLUSHED), THE CEREGLIDE REPORTEDLY GOT STUCK IN THE ZOOM 88. DURING THE ADVANCEMENT OF THE CEREGLIDE 71 CATHETER, THE PHYSICIAN REPORTED THAT IT FELT TIGHT AND AS A RESULT, THE PHYSICIAN REMOVED IT AND THE CEREGLIDE 71 CATHETER STRETCHED. THE PHYSICIAN TRIED THE SECOND CEREGLIDE, A 137 CM CEREGLIDE 71 CATHETER (NIC71137U / 31684676). EVERYTHING FLUSHED WELL BUT THE SAME ISSUE WAS ENCOUNTERED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAY-2026. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY. THE TARGET VESSEL WAS NOT EXCESSIVELY TORTUOUS. THE SECOND CEREGLIDE CATHETER WAS ALSO USED WITH THE ZOOM 88. THE INFORMATION INDICATED THAT FOR BOTH CEREGLIDE CATHETERS, THE ISSUE OCCURRED ON THE FIRST PASS. AFTER THE SECOND CEREGLIDE CATHETER, THE PHYSICIAN USED A ZOOM 7MM X 137MM TO COMPLETE THE PROCEDURE. THE ZOOM 88 WAS ALSO USED TO COMPLETE THE PROCEDUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086331 ↗
• MalfunctionMay 5, 2026Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STROKE PROCEDURE, THE PHYSICIAN USED A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31668075) THROUGH A ZOOM¿88 ASPIRATION CATHETER (IMPERATIVE CARE). BOTH CATHETERS WERE WELL-HYDRATED (FLUSHED), THE CEREGLIDE REPORTEDLY GOT STUCK IN THE ZOOM 88. DURING THE ADVANCEMENT OF THE CEREGLIDE 71 CATHETER, THE PHYSICIAN REPORTED THAT IT FELT TIGHT AND AS A RESULT, THE PHYSICIAN REMOVED IT AND THE CEREGLIDE 71 CATHETER STRETCHED. THE PHYSICIAN TRIED THE SECOND CEREGLIDE, A 137 CM CEREGLIDE 71 CATHETER (NIC71137U / 31684676). EVERYTHING FLUSHED WELL BUT THE SAME ISSUE WAS ENCOUNTERED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAY-2026. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY. THE TARGET VESSEL WAS NOT EXCESSIVELY TORTUOUS. THE SECOND CEREGLIDE CATHETER WAS ALSO USED WITH THE ZOOM 88. THE INFORMATION INDICATED THAT FOR BOTH CEREGLIDE CATHETERS, THE ISSUE OCCURRED ON THE FIRST PASS. AFTER THE SECOND CEREGLIDE CATHETER, THE PHYSICIAN USED A ZOOM 7MM X 137MM TO COMPLETE THE PROCEDURE. THE ZOOM 88 WAS ALSO USED TO COMPLETE THE PROCEDUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086314 ↗
• MalfunctionApr 27, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO THE LEFT MIDDLE CEREBRAL ARTERY, SEGMENT M1, THE PHYSICIAN WAS TRYING TO INSERT THE 137CM CEREGLIDE 71 CATHETER (PRODUCT CODE: NIC71137U, LOT NUMBER: UNKNOWN) INTO A COPILOT TOUHEY THAT WAS CONNECTED TO A ZOOM 88 BASE CATHETER AND HE FELT RESISTANCE. HE REMOVED THE CEREGLIDE AND NOTICED IT WAS KINKED. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-APR-2026 INDICATED THAT THE KINK OCCURRED IN THE PATIENT, PRIOR TO ASPIRATION OR DELIVERING STENT RETRIEVER. THE CATHETER TIP WAS INSIDE THE TOUEY WHEN THE DAMAGE WAS OBSERVED. THE DEVICE/SYSTEM WAS REMOVED OR REPLACED TO CONTINUE THE PROCEDURE. THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING. A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT) WAS USED. THE DEVICE WAS NOT SNAKED. THE ANARTOMOY WAS NOTED AS ¿NORMAL¿. 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 24999606 ↗
• MalfunctionApr 3, 2026Failure to Advance; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE ON (B)(6) 2026, A ¿.071 X 132CM CEREGLIDE 71 WAS USED AND ¿THE CATHETER STRETCHED AFTER OUR FIRST PASS AND THE DOCTOR WOULD LIKE IT REPLACED.¿ THERE WAS NO HARM TO THE PATIENT AND THERE WAS NO DELAY TO THE PROCEDURE. ON (B)(6) 2026, THE CLINICAL ACCOUNT SPECIALIST FOLLOWED UP WITH THE SITE AND GOT THE FOLLOWING ADDITIONAL INFORMATION: ¿THE PHYSICIAN TOLD ME THAT THE [CEREGLIDE] CATHETER COULD NOT GO THROUGH THE BALLAST GUIDE CATHETER. [PER THE SURGICAL TECH], THE CATHETER WAS STRETCHED UPON REMOVAL DURING THE FIRST PASS ASPIRATION. PHYSICALLY, THE CATHETER DOES NOT LOOK STRETCHED BY VISIBLE SITE.¿ THE INFORMATION INDICATED THAT THE DEVICE USED WAS A 132CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71132U / 31679894). THERE WAS NO BREAK IN THE DEVICE INTEGRITY. THE PROCEDURE WAS TARGETING AN OCCLUSION IN THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY (ICA); SOME CALCIFICATION WAS NOTED. THE PROCEDURE WAS AN ADAPT ((DIRECT ASPIRATION FIRST PASS TECHNIQUE) CASE, BUT THE ASSOCIATED TRAK® MICROCATHETER (STRYKER) WAS NOT ¿SNAKED.¿ A SYNCHRO ¿ 14 GUIDEWIRE (STRYKER) WAS ALSO USED. RECANALIZATION WAS NOT ACHIEVED ON THE FIRS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783446 ↗
• MalfunctionMar 18, 2026Retraction Problem; Stretched; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, A 132CM CEREGLIDE 71 CATHETER (PRODUCT CODE: NIC71132U, LOT NUMBER: 31684675) WOULD NOT GO BACK INTO THE GUIDE CATHETER AFTER THE FIRST PASS. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 13-MAR-2026 INDICATED THAT THE CONCOMITANT DEVICE WAS INTACT. THE RESISTANCE DID OCCUR WHEN PUSHING IT THROUGH THE GUIDE CATHETER, BUT NO DAMAGE WAS SEEN ON THE GUIDE CATHETER. THE CEREGLIDE CATHETER DID APPEAR STRETCHED/KINKED. THE CATHETER WAS PULLED OUT ONCE RESISTANCE WAS FELT. NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER CEREGLIDE AND THE PROCEDURE CONTINUED. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628322 ↗
• MalfunctionFeb 4, 2026Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE OCCURRING DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE INVOLVING THE 125 CM CEREGLIDE 71 CATHETER (PRODUCT CODE: NIC71125U, LOT: 31722200) USED COAXIALLY WITH A NON¿J&J MICROCATHETER. DURING ADVANCEMENT, THE CEREGLIDE CATHETER BECAME IMPEDED AT THE C1¿C2 SEGMENT OF THE INTERNAL CAROTID ARTERY AND WAS UNABLE TO REACH THE INTENDED TARGET SITE. THE PHYSICIAN WITHDREW BOTH THE CEREGLIDE CATHETER AND THE MICROCATHETER. UPON REMOVAL, THE CEREGLIDE CATHETER WAS OBSERVED TO BE KINKED/BENT. THE PHYSICIAN REPLACED THE CEREGLIDE DEVICE WITH AN ALTERNATIVE BRAND CATHETER AND COMPLETED THE PROCEDURE SUCCESSFULLY USING THE ORIGINAL MICROCATHETER. NO DELAY IN THERAPY OR PROCEDURAL COMPLICATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 02 FEB 2026 INDICATED THAT THE MICROCATHETER USED WAS IDENTIFIED AS A MEDTRONIC ECHELON10. VESSEL TORTUOSITY WAS PRESENT. NO PHYSICAL MATERIAL OR FOREIGN MATTER WAS IDENTIFIED INSIDE THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY RELATED TO A PRODUCT ISSUE. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260262 ↗
• InjuryDec 18, 2025Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE (AIS) TARGETING AN OCCLUSION IN THE A2 SEGMENT OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA), A CEREBASE, A 137 CM CEREGLIDE 57 CATHETER (NIC57137U / 31766662), AN ARISTOTLE® 18 GUIDEWIRE (SCIENTIA VASCULAR) WERE USED TO NAVIGATE TO THE CLOT FACE. AFTER ONE (1) PASS, A MAJORITY OF THE CLOT WAS REMOVED BUT SOME CLOT HAD MIGRATED DISTAL INTO THE A3 SEGMENT. THE CEREGLIDE 57 CATHETER WAS THEN TRACKED UP AGAIN, BUT IT WAS UNABLE TO REACH THE DISTAL CLOT AND A 160CM CEREGLIDE 42 CATHETER (NIC42160U / 31766628) WAS USED TO REACH THE CLOT. IT WAS REPORTED THAT DURING THE ATTEMPT TO INSIDER THE CEREGLIDE 42 INTO THE CEREGLIDE 57, THE CEREGLIDE 42 WAS UNABLE TO TRAVERSE PAST THE HUB OF THE CEREGLIDE 57. IT WAS NOTED THAT THERE WAS A SMALL KINK IN THE CEREGLIDE 57 CATHETER, BUT IT WAS MUCH MORE DISTAL TO THE HUB OF THE DEVICE, AND IT WAS NOT THE CAUSE OF THE CEREGLIDE 42 CATHETER NOT FITTING INTO THE CEREGLIDE 57 CATHETER. AFTER MANY UNSUCCESSFUL ATTEMPTS OF TRYING TO PUT THE CEREGLIDE 42 INTO THE CEREGLIDE 57, THE PHYSICIAN PULLED THE CEREGLIDE 57 OUT AND TRAVERSED UP TO THE CLOT USING

  Patient problems: Thromboembolism

  MAUDE report 23843470 ↗
• 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 ↗
• MalfunctionNov 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE USING A 125M CEREGLIDE 71 CATHETER (NIC71125U / 31464782), THE FIRST ASPIRATION ATTEMPT WAS SUCCESSFUL. HOWEVER, AFTER REMOVING THE CEREGLIDE CATHETER TO ATTEMPT A SECOND ASPIRATION, THERE WERE TWO FLATTENED AREAS AT THE PROXIMAL END. IT WAS REPORTED THAT ¿EVEN A MICROWIRE COULD NOT PASS THROUGH.¿ THE PROCEDURE WAS CONTINUED USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE AND A PHENOM¿ 27 MICROCATHETER (MEDTRONIC) TO RETRIEVE THE THROMBUS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576990 ↗
• MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A HEALTHCARE PROFESSIONAL REPORTED THAT CONTRAST MEDIA WAS LEAKED OUT FROM THE DISTAL PART OF A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31434338). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534243 ↗
• MalfunctionSep 19, 2025Crack; Crack

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT THIS WAS A MECHANICAL THROMBECTOMY TO TREAT A STROKE IN THE RIGHT PRIMARY MOTOR CORTEX (RM1) REGION. THE HUB OF A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31395153) CRACKED AFTER MULTIPLE USES. IT WAS REPLACED WITH ANOTHER CEREGLIDE 71 132CM (C71) CATHETER AND PROCEDURE WAS FINISHED. ACCESS WAS MADE FROM THE FEMORAL ARTERY. THE CEREGLIDE 71 CATHETER WAS USED A 6 AS WELL.5X45CM EMBOTRAP. THE TECHNOLOGIST BELIEVES ONE PASS WAS MADE WITH THE C71 ASPIRATION ONLY AND THEN ONE PASS WITH EMBOTRAP AND SOME CLOTS WERE REMOVED. WHEN ATTEMPTING THIRD PASS PRIOR TO USING- HUB WAS NOTICED LEAKING SO IT WAS REMOVED AND BAGGED. A NEW C71 WAS USED ON NEXT ASPIRATION PASS AND VESSEL WAS OPEN WITH GOOD RESULTS AND PATIENT DOING WELL. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-SEP-2025 INDICATED THAT THERE WAS NO ALLEGED PRODUCT MALFUNCTION WITH THE EMBOTRAP, HOWEVER, NOT ALL THE CLOT WAS CAPTURED. THE HUB CRACK WAS NOTED WHEN THE USER WAS GOING TO DO ANOTHER ASPIRATION ATTEMPT WITH CATHETER FOLLOWING EMBOTRAP PASS. IT WAS FURTHER NOTED THAT WHEN GETTING PREPARED TO DO ANOTHER PASS WITH C71 OUTSIDE THE BODY NOTICE LEAKING OF SALINE FROM HUB/STRAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097096 ↗
• MalfunctionSep 8, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE ON (B)(6) 2025, TO TREAT AN ISCHEMIC STROKE TARGETING AN OCCLUSION IN THE LEFT INTERNAL CAROTID ARTERY (LICA) AND LEFT M1 (LM1) SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) OR T-OCCLUSION, ACCESS WAS GAINED VIA FEMORAL ACCESS USING AN 8FR SHEATH, A 0.035-INCH GUIDEWIRE, AND AN 8FR FLEXOR® SHUTTLE® GUIDING SHEATH (COOK MEDICAL) WITH A SELECTIVE CATHETER. THE CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31679921) WAS USED. DUE TO TORTUOUS ANATOMY AND THE POSITION OF THE 8 FR. GUIDE, IN THE LICA, THERE WERE SEVERE KINKS IN ANATOMY ABOVE THE LONG GUIDE SHEATH WAS OBSERVED ON ANGIOGRAM; AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER THE CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM AND THE PROCEDURE WAS COMPLETED; THE CLOT WAS REMOVED AND A TICI OF 3 WAS ACHIEVED. KINKS WERE NOTED IN THE COMPLAINT DEVICE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 22-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM WAS ABLE TO REACH THE TARGET AND ASPIRATION WAS ATTEMPTED. WHEN THE REPORTED DAMAGE WAS OBSERVED, THE CEREG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999778 ↗
• MalfunctionSep 8, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, AN ENVOY 6F WAS USED TO SEE WHAT THE OCCLUSION LOOKED LIKE, THEN IT WAS SWITCHED TO A 95CM CEREBASE (PRODUCT, LOT NUMBER UNKNOWN) AND A 132CM CEREGLIDE 71 CATHETER (NIC71132C, LOT UNKNOWN), GLIDING, NO MICROCATHETER, NO WIRE. THEN ASPIRATION WAS UNSUCCESSFUL (DUE TO STENOSIS BEHIND IT). THEN A TRANSEND¿ GUIDEWIRE AND A REBAR 27 MICROCATHETER WERE INSERTED UP AND A 6X40 SOLITAIRE¿ REVASCULARIZATION DEVICE WAS USED. THEN, EVERYTHING WAS REMOVED TOGETHER AND OUTSIDE THE PATIENT, IT WAS DISCOVERED THAT THE DISTAL END OF THE CEREGLIDE WAS FLATTENED. THEN SWITCHED TO SOFIA 5F AND STENT RETRIEVER (ALSO UNSUCCESSFUL), THEN FINALLY WITH CEREBASE UP AND DIRECT ASPIRATION IT WAS SUCCESSFUL. BUT THE PATIENT KEPT FORMING THROMBI (VERY QUICKLY). THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992929 ↗
• MalfunctionSep 3, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY, WITH A 132CM CEREGLIDE 71 CATHETER (NIC71132U, 31347322). THE PHYSICIAN COMPLETED FIRST PASS, REMOVED AND CLEANED THE CEREGLIDE AND BEFORE RE-INSERTING THE CATHETER FOR A SECOND PASS NOTICED A ¿CRIMP¿ APPROX. 10CM PROXIMAL TO THE DISTAL TIP OF THE CATHETER. HE COMPLETED THE PROCEDURE WITH A DIFFERENT CATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-AUG-2025 INDICATED THAT THE TARGET VESSEL/SITE WAS AN OCCLUSION AT THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). IT WAS FURTHER CLARIFIED THAT THE CATHETER HAD A ¿FLATTENED¿ KINK ABOUT 10CMS FROM DISTAL TIP. NORMAL ANATOMY WAS NOTED. THE PHYSICIAN EXPECTED THAT IT HAPPENED IN THE RHV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954915 ↗

Other Cerenovus, Inc. products

• GALAXY G358 models · 1,386 reports · 1 recall
• CODMAN41 models · 107 reports · 22 recalls
• MICRUSFRAME47 models · 298 reports
• DELTAFILL29 models · 294 reports
• CEREPAK FREEFORM60 models · 166 reports · 1 recall
• CEREBASE3 models · 143 reports · 1 recall
• DELTAXSFT13 models · 130 reports
• CEREPAK UNIFORM58 models · 33 reports · 1 recall