EMBOGUARD BG8785URecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886704082736), received between Sep 6, 2022 and May 14, 2026 — classified as 1 death, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionMay 14, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE DISTAL BODY OF AN EMBOGUARD 87, 85 CM (PRODUCT CODE: BG8785U, LOT NUMBER: 9728701) WAS KINKED WHEN DEPLOYED CAROTID STENT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-MAY-2026 INDICATED THAT THE PROCEDURE WAS A COMBINED CAROTID STENTING (CAS) AND THROMBECTOMY TANDEM CASE. THE PROBLEM OCCURRED AT THE CAS CASE AFTER THE THROMBECTOMY WAS COMPLETED. RECANALIZATION HAD BEEN ACHIEVED. NO ADDITIONAL PASSES WERE PLANNED WHEN THE DAMAGE OCCURRED. THE DEVICE/SYSTEM HAD TO BE REMOVED OR REPLACED TO CONTINUE THE PROCEDURE. THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE EVENT DID NOT RESULT IN PATIENT HARM. THIS WAS NOT A DIRECT ASPIRATION FIRST PASS TECHNIQUE CASE. THE TARGET VESSEL/SITE BEING TREATED WAS THE COMMON CAROTID ARTERY (CCA). 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 25175278 ↗
• MalfunctionFeb 2, 2026Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A CAROTID STENTING PROCEDURE WITH A RIGHT RADIAL ARTERY APPROACH TO TREAT RIGHT INTERNAL CAROTID ARTERY STENOSIS. ATER THE RIGHT RADIAL PUNCTURE, THE EMBOGUARD BALLOON CATHETER 87, 85 CM (BG8785U/(B)(6)) WITH A NON-J&J TOKAI MEDICAL TMP DILATOR SET ON 0.035 HALF STIFF GUIDEWIRE WERE ADVANCED FROM THE RIGHT RADIAL ARTERY TO THE RIGHT SUBCLAVIAN ARTERY. THE INNER CATHETER WAS REPLACED WITH A NON-J&J 6FR JB2, AND WAS ADVANCED TO THE RIGHT COMMON CAROTID ARTERY. AFTER REMOVING THE JB2, AND OPTIMAL WIRE WAS ADVANCED DISTAL TO THE LESION. AT THAT TIME, SOME RESISTANCE WAS FELT AT THE STEEP CURVE FROM THE RIGHT SUBCLAVIAN ARTERY TO THE RIGHT COMMON CAROTID ARTERY, BUT THE WIRE WAS ADVANCED, NONETHELESS. AT THE STENOTIC AREA, THE OPTIMAL WIRE COULD NO LONGER BE ADVANCED. UPON INSPECTION, THE EMBOGUARD CATHETER WAS FOUND KINKED AT THE AFOREMENTIONED CURVE. SINCE CONTINUATION OF THE PROCEDURE WAS JUDGED TO BE DIFFICULT, THE EMBOGUARD CATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND REPLACED WITH A NON-J&J OPTIMO (TOKAI MEDICAL) TO CONTINUE THE PROCEDURE. AFTER THAT, THE PLANNED STENTING WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235914 ↗
• MalfunctionJan 6, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, AN EMBOGUARD 87, 85 CM BALLOON CATHETER (PRODUCT CODE BG8785U, LOT NUMBER 9840114) KINKED DURING REMOVAL OF THE INNER DEVICE, LEADING TO ITS REMOVAL FROM THE PATIENT AND REPLACEMENT WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO NEGATIVE IMPACT OR CONSEQUENCE TO THE PATIENT. THE AFFECTED DEVICE WAS NO LONGER USABLE FOLLOWING THE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-JAN-2026 INDICATED THAT THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980969 ↗
• MalfunctionNov 12, 2025Difficult to Advance; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY TO TREAT ACUTE ISCHEMIC STROKE (AIS). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). BALLON GUIDING CATHETER (BGC) GUIDANCE WAS PERFORMED USING A RADIFOCUS 35 WIRE AND A CO-AXIAL SYSTEM WITH NEWTON T 4FR AND 6FR. FIRST, WHEN THE 8FR SHEATH WAS INSERTED, THE BLOOD VESSEL WAS SEVERELY TORTUOUS AND THE SHEATH GOT SLIGHTLY KINKED. 4FR NEWTON T AND RADIFOCUS 35 WIRE WERE SET ON AN EMBOGUARD 87, 85 CM BALLON GUIDE CATHETER (BG8785U, 9840110) AND INSERTED INTO THE PATIENT¿S BODY THROUGH THE SHEATH. SINCE IT WAS DIFFICULT TO DELIVER FROM AORTIC ARCH TO RIGHT INTERNAL CAROTID ARTERY, THE EMBOGUARD 87, 85 CM WAS REPLACED WITH ANOTHER EMBOGUARD 87, 95 CM (BG8795U, 9686548), AND 6FR NEWTON T WAS ADDED AS DIRECT ACCESS CATHETER. REINSERTION WAS PERFORMED, ADVANCING APPROXIMATELY 16 CM FROM THE BIFURCATION OF BRACHIOCEPHALIC ARTERY, AND WITH SLIGHT INFLATION, THE SYSTEM WAS SUCCESSFULLY DELIVERED TO THE RIGHT INTERNAL CAROTID ARTERY. THE PHYSICIAN COMMENTED THAT THE INNER DEVICE WAS FORCIBLY WITHDRAWN. AFTERWARDS, WHEN ATTEMPTING TO INFLATE, RESISTANCE WAS FELT, AND UPON RE-DELIVERING THE 35 GUIDEWIRE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533918 ↗
• MalfunctionNov 10, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY FOR TREATMENT OF AN ACUTE ISCHEMIC STROKE, THE LESION WAS TANDEM. THE EMBOGUARD 87, 85 CM BALLOON CATHETER (BG8785U, 9840112) PREPARATION WAS COMPLETED AND INSERTED INTO THE SHEATH. BECAUSE THIS WAS A TANDEM CASE, THE EMBOGUARD WAS RETAINED IN THE COMMON CAROTID ARTERY (CCA) TO CONTINUE THE PROCEDURE. THE EMBOGUARD KINKED DURING WITHDRAWAL OF THE INNER DEVICE, SO IT WAS REPLACED WITH AN OPTIMO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512877 ↗
• MalfunctionAug 7, 2025Material Twisted/Bent; Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M1P TO TREAT ACUTE ISCHEMIC STROKE BY A DIRECT ASPIRATION FIRST-PASS TECHNIQUE (ADAPT) USING REACT71 CATHETER. THE DEVICES WERE USED AS PER THE INSTRUCTIONS FOR USE (IFU). THE EMBOGUARD 87, 85 CM BALLOON GUIDE CATHETER ((B)(6), (B)(6)) WAS ADVANCED WITH THE 6FR ANGIOGRAPHIC CATHETER AND 35 GUIDEWIRES, WHICH WAS PLACED ON PRE PETROUS. WHEN THE ANGIOGRAPHIC CATHETER AND GUIDEWIRE WERE REMOVED FROM THE PATIENT¿S BODY, THE EMBOGUARD GRADUALLY SLIPPED DOWN. WHEN THE ASPIRATION CATHETER REACT WAS ADVANCED, THE EMBOGUARD SLIPPED TO A POSITION WHERE IT COULD NO LONGER BE VISUALIZED UNDER EXPANDED VIEW. ADAPT TECHNIQUE WAS PERFORMED USING THE REACT. WHEN THE REACT WAS REMOVED FROM THE PATIENT¿S BODY, THE FLUOROSCOPY REVEALED THAT THE EMBOGUARD GOT KINKED AT THE BENDING PART OF THE AORTA. THE ANGIOGRAPHY WAS PERFORMED AS IT WAS, AND RECANALIZATION WAS ACHIEVED. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON (B)(6) 2025 INDICATING THAT THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741743 ↗
• MalfunctionAug 5, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY BY COMBINED TECHNIQUE USING ESPERANCE ASPIRATION CATHETER AND EMBOTRAP (PRODUCT AND LOT UNKNOW). DURING THE ADVANCEMENT OF AN EMBOGUARD 87, 85 CM BALLOON GUIDE CATHETER (BG8785U, 9833512) TO THE INTERNAL CAROTID ARTERY, THE EMBOGUARD GOT KINKED. THE EMBOGUARD WAS REPLACED WITH AN OPTIMO BALLOON GUIDE CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717129 ↗
• MalfunctionJul 7, 2025Burst Container or Vessel; Difficult to Advance; Burst Container or Vessel; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID ARTERY STENTING PROCEDURE TARGETING THE LEFT INTERNAL CAROTID ARTERY STENOSIS, THE 85CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8785U / 9833512) WAS PREPARED OUTSIDE THE PATIENT¿S BODY. IT WAS THEN INSERTED INTO THE RIGHT RADIAL ARTERY. HOWEVER, DURING THE ATTEMPT TO ADVANCE TO THE LEFT COMMON CAROTID ARTERY, THE EMBOGUARD COULD NOT BE ADVANCED. TO PERFORM THE FLOATING TECHNIQUE FOR GUIDING WITH THE BALLOON IN AN INFLATED STATE, THE EMBOGUARD WAS INFLATED, BUT IT COULD NOT BE INFLATED. THE PHYSICIAN JUDGED THAT THE BALLOON HAD RUPTURED AND THE EMBOGUARD WAS REMOVED FROM THE PATIENT¿S BODY IT WAS REPLACED WITH A NEW EMBOGUARD BGC, A 95CM EMBOGUARD. THE PROCEDURE WAS SUCCESSFUL COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 16-JUN-2025, PRELIMINARY / PRE-SHIPMENT PHOTOS WERE ADDED IN THE COMPLAINT. THE PRODUCT ANALYSIS LAB TEAM WILL REVIEW THE PHOTOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413554 ↗
• DeathJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EMBOGUARD 87, 85 CM (BG8785U/ 0000203033) AND AN IC 71, 132 CM, US CEREGLIDE INTERMEDIATE CATHETER (NIC71132U/ 31101932) WAS USED FOR A THROMBECTOMY PROCEDURE. PER THE EVENT DESCRIPTION, ¿CEREGLIDE TRACKED TO THE CLOT AND REMOVED WITH ASPIRATION. PHYSICIAN PERFORMED ANGIOGRAM AND NOTED A LACK OF BLOOD FLOW TO THE BRAIN. PROCEDURE WAS DISCONTINUED.¿ THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS REPORTED AS ¿IRREVERSIBLE COMA.¿ THE EVENT REQUIRED THE MEDICAL INTERVENTION OF A ¿[COMPUTED TOMOGRAPHY] CT.¿ ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024. SUMMARY: PER THE INFORMATION RECEIVED, THE PATIENT¿S BASELINE/PRE-PROCEDURE NEUROLOGICAL STATUS WAS ¿LEFT SIDED SENSORY AND UPPER EXTREMITY MOTOR DEFICITS.¿ THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN; ¿UNKNOWN (TRANSFER FROM OUTSIDE HOSPITAL).¿ THE TREATING PHYSICIAN'S OPINION ON CONTRIBUTING FACTORS FOR THE EVENT OF LACK OF BLOOD FLOW TO BRAIN WAS ¿PROLAPSE OF EMBOGUARD CONTRIBUTED TO FORWARD TENSION APPLIED TO CEREGLIDE.¿ IT WAS FURTHER COMMENTED THAT THE EVENT WAS ASSOCIATED WITH VESSEL TRAUMA FROM THE DEVICES. ¿NO DAMAGE OF PRODUCTS WAS NOTED.¿ ANOTHER CONCO

  Patient problems: Stroke/CVA

  MAUDE report 18571294 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA EMAIL, THAT A IC 71, 132 CM, US (NIC71132U/ 31106962) CEREGLIDE71 INTERMEDIATE CATHETER, AN EMBOGUARD 87, 85 CM (BG8785U/LOT # UNKNOWN), AND AN EMBOTRAP III 5 MM X 37 MM (ET309537/ LOT # UNKNOWN), WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE WITH CAROTID STENTING IN A 72-YEAR-OLD FEMALE PATIENT WITH A RIGHT MIDDLE CEREBRAL ARTERY OCCLUSION AND PROXIMAL CAROTID ARTERY STENOSIS. DURING THE PROCEDURE, THE TREATING PHYSICIAN ADVANCED THE CEREGLIDE71 TO THE ¿OPTHALMIC¿ AND NOTED IT WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN ¿REMOVED CEREGLIDE-71 FROM TABLE, [AND] NOTED THAT THE CATHETER KINKED JUST DISTAL TO THE STRAIN RELIEF.¿ A SECOND IC 71, 132 CM, US (NIC71132U/ 31106962) CEREGLIDE71 INTERMEDIATE CATHETER WAS USED INSTEAD. THE PROCEDURE CONTINUED AND THE EMBOTRAP III DEVICE WAS DEPLOYED, WHICH ALLOWED THE CEREGLIDE71 TO ADVANCE TO THE CLOT. THE EMBOGUARD WAS INFLATED, THE PUMP WAS STARTED, AND THE CLOT WAS ALLOWED TO EMBED FOR THREE MINUTES. THE SYSTEM WAS RETRIEVED AND A TICI SCORE OF 3 (COMPLETE PERFUSION) WAS ACHIEVED. HOWEVER, ¿DURING THE RUN, A VASOSPASM WAS NOTED IN THE INTERNAL CAROTID ARTERY (ICA).¿ IT IS UNKNOWN HOW LONG THE VASOSPASM LASTED

  Patient problems: Vasoconstriction

  MAUDE report 18310741 ↗
• MalfunctionDec 5, 2022Deflation Problem; Deflation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PREPARATION OF AN 85CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BG8785U / 0000169220), AFTER THE INITIAL INFLATION OF THE BALLOON CATHETER, IT TOOK AN ABNORMAL AMOUNT OF TIME FOR THE BALLOON CATHETER TO DEFLATE UNDER NORMAL ASPIRATION; THE BALLOON CATHETER REQUIRED LIGHT COMPRESSION TO ¿ENCOURAGE¿ THE BALLOON CATHETER TO DEFLATE. A SECOND INFLATION AND DEFLATION WAS PERFORMED AND THE SAME ISSUE WAS OBSERVED. THE EMBOGUARD BALLOON CATHETER WAS DEEMED UNSAFE TO USE DUE TO THE PROLONGED DEFLATION TIMES OUTSIDE OF THE NORMAL DEFLATION TIMES. IT WAS REPORTED THAT A SECOND EMBOGUARD BALLOON CATHETER WAS PREPARED IN THE SAME METHODS. WHILE DEFLATION TIMES WERE SLOWER THAN NORMAL, THE DEFLATION TIMES WERE ACCEPTABLE WITH THE SECOND EMBOGUARD. A 50:50 MIXTURE OF HEPARINIZED SALINE AND VISIPAQUE 320 WAS USED COMPARED TO OMINIPAQUE 300. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE PROCEDURE WAS COMPLETED USING ANOTHER 85CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BG8785U). ON 22-NOV-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE SECOND EMBOGUARD BALLOON CATHETER USED TO COMPLETE THE PROCEDURE WAS FR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921117 ↗
• MalfunctionOct 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY A SALES REPRESENTATIVE, AN EMBOGUARD 87, 85 CM BALLOON GUIDE CATHETER (BG8785U, 0000155432) WAS PREPPED OUTSIDE THE PATIENT. THE BALLOON WAS INFLATED AND TESTED BEFORE INTRODUCED INTO PATIENT. AFTER THE EMBOGUARD (EG) WAS PLACED, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON AND HE NOTICED THE CONTRAST ESCAPING THE BALLOON UNDER X-RAY. THE PHYSICIAN USED THE EG EITHER WAY TO FINISH CASE WITH NO COMPLAINT. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT AN 8F 11CM SHEATH WAS USED. BALLOON WAS INFLATED USING LAV. A 1ML SYRINGE WAS USED TO GENTLY INFUSE CONTRAST MATERIAL IN BALLOON. THE LEAK WAS LOCATED ON THE BALLOON ITSELF. THE DEVICE DID NOT APPEAR TO BE KINKED OR DAMAGED IN ANY WAY. THERE WAS NO EVIDENCE OF AIR BEING INJECTED INTO PATIENT. TREATMENT WAS TO THE RIGHT MIDDLE CEREBRAL ARTERY (RMCA) WITH MILD TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615196 ↗
• MalfunctionSep 6, 2022Defective Component; Defective Component

  AS REPORTED BY THE FIELD, AB EMBOGUARD BALLOON GUIDE CATHETER 87, 85 CM (BG8785U, LOT UNKNOWN) WAS PREPPED PRIOR TO USE PER THE TECHNICIAN. AFTER PHYSICIAN USE, BALLOON WAS NOTED TO HAVE A DEFECT IN FILLING. THE BALLOON HAS A PIMPLE ON THE BALLOON THAT FILLS UPON BALLOON INFLATION. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGICAL ACCESS POINT WAS THE FEMORAL ARTERY. AN INTRODUCER SHEATH WAS NOT USED. THERE WAS NO USE OF PEEL-AWAY SHEATH. A DILATOR WAS USED. THE BALLOON DID NOT BURST AT THE SITE OF THE "PIMPLE". THE CASE WAS COMPLETED WITH THE SAME EMBOGUARD. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. IT WAS CONFIRMED THAT THE ISSUE OCCURRED AFTER USE IN THE PATIENT. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, A BALLOON LEAKAGE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362303 ↗