CEREGLIDE SBC92122UGRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704086048), received between Dec 2, 2024 and Sep 8, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (3 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 3, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT A DURING A MECHANICAL THROMBECTOMY, A CEREGLIDE 92 CATHETER (SBC92122UG, LOT UNKNOWN) WAS BEING ADVANCED TO THE MIDDLE CEREBRAL ARTERY (MCA) DURING AN ISCHEMIC STROKE, THE MIDDLE PORTION OF THE CEREGLIDE 92 BUCKLED AND KINKED. THE PHYSICIAN DECIDED TO ASPIRATE ON THE CEREGLIDE 92 (CG), AND 10CM WORTH OF CLOT WAS SUCTIONED OUT THROUGH THE CG92 IN ONE PASS. TICI 3 WAS ACHIEVED. THE PHYSICIAN DID HAVE DIFFICULTY IN REMOVING THE CG92 SINCE IT HAD FOLDED AT THE KINK LOCATION, BUT WAS FINALLY ABLE TO USE THE 8FR COOK SHUTTLE TO ADVANCE OVER THE KINKED PORTION OF THE CG92 AND REMOVED BOTH. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-AUG-2025 INDICATED THAT THE LOT NUMBER IS NOT AVAILABLE. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICE. THE VESSEL WAS NOT TORTUOUS, NORMAL TYPE 1 ARCH. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952309 ↗
• MalfunctionAug 18, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TARGETING A CLOT AT THE M1/M2 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), A 9FR 70CM FLEXOR® RAABE GUIDING SHEATH (COOK MEDICAL) WAS PLACED IN THE RIGHT COMMON CAROTID ARTERY (CCA). IT WAS REPORTED THAT THE CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31485382) AND ARISTOTLE® 24 GUIDEWIRE (SCIENTIA VASCULAR) WERE TRACKED TO THE CLOT FACE IN THE RIGHT M1 SEGMENT. THE INNERGLIDE 9 AND ARISTOTLE® 24 GUIDEWIRE WERE REMOVED SLOWLY FROM THE CEREGLIDE 92. ASPIRATION WAS APPLIED TO THE CEREGLIDE 92 USING THE PENUMBRA PUMP SYSTEM® (PENUMBRA) AND TUBING. THE PHYSICIAN WAS SEEING FLOW IN THE TUBING AND MOVED THE CATHETER INTO THE CLOT AND THEN PULLED BACK SLIGHTLY. THE FLOW STOPPED. AFTER TWO MINUTES, THE CEREGLIDE 92 WAS REMOVED. THE DISTAL 25CM TO 30CM OF THE CEREGLIDE HAD FLATTENED / COLLAPSED. A SECOND CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31485382) WAS OPENED AND ADVANCED TO THE CLOT IN THE SAME FASHION. THE CEREGLIDE 92 WAS NOT ADJUSTED THIS TIME AND ONCE ASPIRATION WAS TURNED ON, NO FLOW WAS OBSERVED. WHEN THE CEREGLIDE 92 WAS REMOVED, THE SAME FLATTENED / COLLAPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833646 ↗
• MalfunctionAug 18, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TARGETING A CLOT AT THE M1/M2 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), A 9FR 70CM FLEXOR® RAABE GUIDING SHEATH (COOK MEDICAL) WAS PLACED IN THE RIGHT COMMON CAROTID ARTERY (CCA). IT WAS REPORTED THAT THE CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31485382) AND ARISTOTLE® 24 GUIDEWIRE (SCIENTIA VASCULAR) WERE TRACKED TO THE CLOT FACE IN THE RIGHT M1 SEGMENT. THE INNERGLIDE 9 AND ARISTOTLE® 24 GUIDEWIRE WERE REMOVED SLOWLY FROM THE CEREGLIDE 92. ASPIRATION WAS APPLIED TO THE CEREGLIDE 92 USING THE PENUMBRA PUMP SYSTEM® (PENUMBRA) AND TUBING. THE PHYSICIAN WAS SEEING FLOW IN THE TUBING AND MOVED THE CATHETER INTO THE CLOT AND THEN PULLED BACK SLIGHTLY. THE FLOW STOPPED. AFTER TWO MINUTES, THE CEREGLIDE 92 WAS REMOVED. THE DISTAL 25CM TO 30CM OF THE CEREGLIDE HAD FLATTENED / COLLAPSED. A SECOND CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31485382) WAS OPENED AND ADVANCED TO THE CLOT IN THE SAME FASHION. THE CEREGLIDE 92 WAS NOT ADJUSTED THIS TIME AND ONCE ASPIRATION WAS TURNED ON, NO FLOW WAS OBSERVED. WHEN THE CEREGLIDE 92 WAS REMOVED, THE SAME FLATTENED / COLLAPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833645 ↗
• InjuryMay 20, 2025Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO TREAT AN ISCHEMIC STROKE, CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31495978) WAS USED. TWO SUCCESSFUL PASSES WERE MADE WITH THE DEVICE. THE SURGEON DID NOT NOTICE THE DAMAGE UNTIL TRYING TO PLACE THE DEVICE INTO THE GUIDE SHEATH FOR A THIRD PASS. THE CEREGLIDE WAS NOTICED TO BE KINKED. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. TWO PHOTOS OF THE COMPLAINT DEVICE WERE INCLUDED IN THE FILE. THE PHOTOS WILL BE REVIEWED BY THE PRODUCT ANALYSIS TEAM. ON 15-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS A 62-YEAR-OLD FEMALE. THE INFORMATION INDICATED THAT THERE WAS AN UNDUE DELAY IN THE PROCEDURE, ¿WHEN ATTEMPTING TO PLACE THE CEREGLIDE 92 FOR A THIRD PASS, IT WAS UNABLE TO ADVANCE INTO THE RHV, THEY HAD TO GET ANOTHER CATHETER OFF THE SHELF TO CONTINUE WITH THE PROCEDURE. ADDING TIME TO THE CASE.¿ THE PROCEDURE WAS AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) TARGETING THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE INFORMATION ALSO INDICATED THAT THE VESSEL WAS TORTUOUS AT THE INTERNAL CAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057717 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE THAT WAS TARGETING A THROMBUS IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), THE PHYSICIAN WAS USING CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31485382) AND A 137 CM CEREGLIDE 71 CATHETER (NIC71137U / 31528444). IT WAS REPORTED THAT, ¿AFTER [THE] FIRST PASS, 2A AND DISTAL MIGRATION OF CLOT. [A SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC)] WAS USED AND TICI3 WAS OBSERVED WITH SMALL DISSECTION. NO TREATMENT OF DISSECTION WAS REQUIRED, AND [THE] PATIENT WAS STABLE. THIS IS NOT A PARTICULAR DEVICE COMPLICATION, RATHER A CASE NOTATION.¿

  Patient problems: Thromboembolism

  MAUDE report 22048774 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A CEREGLIDE92 SBC 92 122 CM US (SBC92122UG) WAS USED FOR THROMBECTOMY PROCEDURE FOR A TANDEM OCCLUSION ISCHEMIC STROKE. AFTER RECANALIZATION WAS ACHIEVED ON THE FIRST PASS, THE PHYSICIAN NOTICED A DISSECTION AT THE CERVICAL SECTION OF THE INTERNAL CAROTID ARTERY. THE PHYSICIAN PUT A LONG GUIDE SHEATH OVER THE CEREGLIDE 92, THEN PLACED A CERVICAL STENT WHERE THE DISSECTION OCCURRED. IT WAS REPORTED THE PROCEDURE TIME WAS EXTENDED DUE TO THE ADDITIONAL SURGICAL INTERVENTION OF PLACING A STENT AT THE DISSECTION SITE. THE PATIENT¿S CURRENT STATUS IS UNKNOWN. THE EVENT WAS REPORTED AS SUCH, ¿TANDEM OCCLUSION ISCHEMIC STROKE. MADE ACCESS WITH AN 8F SHORT SHEATH. TOOK ARISTOTLE 24 WIRE & INNERGLIDE 9 UP TO THE FACE OF THE CLOT AT ICA TERMINUS, FOLLOWED BY THE CEREGLIDE 92 CATHETER. WAS ABLE TO ASPIRATE AND REMOVE THE CLOT IN ONE PASS. ONCE HE REMOVED THE CLOT, HE NOTICED A DISSECTION AT THE CERVICAL SECTION OF THE INTERNAL CAROTID. HE THEN PUT A LONG GUIDE SHEATH OVER THE CEREGLIDE 92, THEN PLACED A CERVICAL STENT WHERE THE DISSECTION OCCURRED.

  Patient problems: Vascular Dissection

  MAUDE report 21631548 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A CEREGLIDE92 SBC 92 122 CM US (SBC92122UG) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE THROMBUS WAS REMOVED WITH ONE RETRIEVAL ATTEMPT. ONCE THE DEVICES WERE REMOVED, A DISSECTION WAS FOUND APPROXIMATELY 5CM DISTAL OF THE PLACEMENT OF THE LONG GUIDE SHEATH. THE PATIENT WAS MONITORED FOR TWO DAYS WITH NO IMPROVEMENT. THE PATIENT WAS THEN RETURNED TO THE LAB FOR PLACEMENT OF A MEDTRONIC PIPELINE WHERE DISSECTION OCCURRED. THE EVENT WAS REPORTED AS SUCH, ¿DOCTOR HAD A CASE ON (B)(6) 2025. RT. M1 OCC. 60-YEAR-OLD PT. PLACED A PINNACLE DESTINATION IN ICA. TOOK ARISTOTLE 24 WIRE & INNERGLIDE 9 UP TO THE FACE OF THE CLOT AT M1, FOLLOWED BY THE CG92 CATHETER. WAS ABLE TO ASPIRATE AND REMOVE THE CLOT IN ONE PASS. ONCE HE PULLED THE ENTIRE SYSTEM, HE NOTICED A DISSECTION APPROXIMATELY 5CM DISTAL OF THE PLACEMENT OF THE LONG GUIDE SHEATH. MONITORED THE PATIENT. IT DID NOT IMPROVE. RETURNED PATIENT TO THE LAB ON (B)(6) 2025 AND PLACED A MEDTRONIC PIPELINE WHERE DISSECTION OCCURRED. WILL FOLLOW UP WITH PT. IMAGES, PRE, DURING AND POST CASE. THE SURGERY WAS

  Patient problems: Vascular Dissection

  MAUDE report 21515004 ↗
• InjuryDec 2, 2024Material Deformation; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO TREAT A RIGHT M2 ISCHEMIC STROKE, ACCESS WAS MADE VIA THE RIGHT FEMORAL ARTERY USING AN 8F 90CM FLEXOR® SHUTTLE® GUIDING SHEATH (COOK MEDICAL) PLACED INTO THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY (ICA). A CEREGLIDE 92 INNERGLIDE 9 122 CM CATHETER SYSTEM (SBC92122UG / 31472255) WAS BROUGHT UP WITH AN ARISTOTLE® 24 GUIDEWIRE (SCIENTIA VASCULAR). THE ARISTOTLE GUIDEWIRE AND THE CEREGLIDE 92 INNER GLIDE 9 WAS BROUGHT UP TO PROXIMAL TO FACE THE CLOT AT THE M1/M2 BIFURCATION. THE CEREGLIDE 92 WAS BROUGHT UP OVER THE INNER GLIDE 9 TO FACE THE CLOT. MANUAL ASPIRATION WAS APPLIED TO THE CEREGLIDE 92. THE CEREGLIDE 92 WAS THEN BROUGHT BACK TO DISTAL ICA. THE VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL) WAS REMOVED AND NO CLOT WAS SEEN IN THE DISCARD / ASPIRATE OF THE ALOK. MANUAL CONTRAST INJECTION THROUGH THE CEREGLIDE 92 SHOWED A TICI SCORE OF 2B WITH BLOOD FLOW RESTORED. THERE WERE STILL CLOT IN THE RIGHT M2 SEGMENT; THE PHYSICIAN WENT BACK UP WITH THE INNER GLIDE 9 AND THE ARISTOTLE GUIDEWIRE TO FACE THE CLOT IN THE M2, THE CEREGLIDE 92 WAS TRACKED OVER. MANUAL ASPIRATION WAS APPLIED TO THE CEREGLIDE 9

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vasoconstriction

  MAUDE report 20822501 ↗