EMBOGUARDRecalls & reported problems across all models

We found 2 models of EMBOGUARD by Neuravi Limited in the FDA's device registry (GUDID). Together they are named in 166 adverse event reports in the FDA's MAUDE database, received between May 31, 2022 and Sep 30, 2026 — classified as 3 deaths, 34 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (61 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 EMBOGUARD problems

EMBOGUARD models

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

• EMBOGUARD BG8795U

  Catheter, Percutaneous, Neurovasculature
  2 deaths153 reports
• EMBOGUARD BG8785U

  Catheter, Percutaneous, Neurovasculature
  1 death13 reports

Recent EMBOGUARD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955182 ↗
• MalfunctionSep 15, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782231 ↗
• MalfunctionSep 14, 2026Break

  A healthcare professional reported that during treatment to a cerebral aneurysm an EMBOGUARD 87, 95 CM Balloon Guide Catheter (product code: BG8795U, lot number: 10449662) was placed in the internal carotid artery, and upon inflation of the balloon, the balloon was found to have ruptured. The balloon was inflated to facilitate advancement of the EmboGuard distally, but due to the balloon rupture, the procedure was continued with the EmboGuard remaining at the internal carotid artery. The procedure was completed successfully without further issues. The devices were used according to the instructions for use (IFU). There was no negative impact to the patient. A continuous flush was done. The lesion was internal carotid artery. Other concomitant devices were Exselsior SL 10 microcatheter.Additional event information received on 28-Aug-2026 and 31-Aug-2026 confirmed that there was no allegation of patient injury due to an alleged product issue. No balloon fragments were observed. According to the physician, the balloon did not rupture due to overinflation; rather, it is possible that the balloon had developed a tear at some point, which prevented it from being inflated. Final angiograp

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752987 ↗
• MalfunctionJun 18, 2026Burst Container or Vessel

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, AN EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 9301096) EXPERIENCED BALLOON INFLATION, IT COULD NOT WITHSTAND THE PRESSURE AND BURST. IT WAS NOTED THAT THE AMOUNT INJECTED WAS AS STATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549751 ↗
• MalfunctionMay 26, 2026Material Separation; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY TO TREAT ACUTE ISCHEMIC STROKE. THE PROCEDURE WAS PERFORMED BY COMBINED TECHNIQUE USING REACT 71 CATHETER. THE PROCEDURE WAS PERFORMED AS USUAL. THE EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10293947) WAS CONFIRMED TO BE COMPLETELY BROKEN. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH DONE. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280245 ↗
• MalfunctionMay 19, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT ACUTE ISCHEMIC STROKE (AIS), A 0.035 GUIDEWIRE, AN INNER CATHETER, AND AN EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10293947) WERE ADVANCED TO THE COMMON CAROTID ARTERY. UPON REMOVAL OF THE INNER CATHETER, A KINK WAS OBSERVED ON THE EMBOGUARD, SO IT WAS REPLACED WITH A NEW BALLOON GUIDING CATHETER. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. PUNCTURE SITE WAS THE GROIN. KINKING OCCURRED UPON REMOVAL OF THE INNER CATHETER. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EMBOGUARD WAS PREPARED ACCORDING TO IFU. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-MAY-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 25218456 ↗
• MalfunctionMay 19, 2026Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE DISTAL PART 5CM OF AN EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 9914821) WAS KINKED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 02-MAY-2026 INDICATED THAT THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO DIFFICULTY IN REMOVING DEVICE FROM PACKAGING. THE EVENT DID NOT RESULT IN ANY CONSEQUENCE OR INJURY TO THE PATIENT. THERE WAS NO BREAK IN DEVICE INTEGRITY AT THE SITE OF THE DEFECT. THE SURGICAL PROCEDURE WAS FROM THE FEMORAL ARTERY. A 8F INTRODUCER SHEATH WAS USED. THE DEVICE WAS NOT ABLE TO REACH THE TARGET POSITION. NO ASPIRATION WAS ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216757 ↗
• 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 ↗
• MalfunctionMay 13, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY, SEGMENT M1 TO TREAT ACUTE CEREBRAL INFARCTION. ATTEMPTED TO ADVANCE THE EMBOGUARD 87, 95 CM BALLOON CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 10140061), BUT THE AORTA WAS LOOPED. AFTER ADVANCING TO THE COMMON CAROTID ARTERY, REMOVED THE INNER CATHETER, AT THAT TIME THE EMBOGUARD GOT KINKED. REPLACED THE EMBOGUARD WITH A NEW ONE AND ADVANCED AGAIN. THE NEW EMBOGUARD COULD BE ADVANCED WITHOUT ISSUE, AND RECANALIZATION WAS ACHIEVED BY ONE PASS USING A COMBINED TECHNIQUE (A CEREGLIDE 71 AND EMBOTRAP 5X37). THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163025 ↗
• MalfunctionMay 6, 2026Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY TO TREAT AN ACUTE ISCHEMIC STROKE (AIS). DURING ADVANCEMENT OF THE EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10293947) DID NOT ADVANCE FULLY TO THE INTERNAL CAROTID ARTERY (ICA) AND GOT KINKED WHEN THE INNER DEVICE WAS WITHDRAWN. AFTER THE EMBOGUARD REMOVAL, REPLACED WITH A NEW EMBOGUARD AND CHANGED THE METHOD OF ADVANCING. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. PUNCTURE SITE WAS THE GROIN. THE KINKING OCCURRED DURING REMOVAL OF THE INNER CATHETER. LOCATION OF CATHETER TIP: COMMON CAROTID ARTERY (CCA). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PERFORMED AIR REMOVAL ACCORDING TO IFU. ADDITIONAL EVENT INFORMATION RECEIVED ON 06-MAY-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 25096331 ↗
• MalfunctionMay 4, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE (AIS), AN EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 10140061) WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND USED AS A BALLOON GUIDE CATHETER. DURING USE, KINKING OCCURRED WHEN THE INNER DEVICE WAS WITHDRAWN, SO THE EMBOGUARD WAS REPLACED WITH ANOTHER NEW BALLOON GUIDE CATHETER (BGC) AND THE PROCEDURE WAS RESUMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. LOCATION OF THE CATHETER TIP WAS THE COMMON CAROTID ARTERY (CCA). A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-APR-2026 INDICATED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071017 ↗
• MalfunctionApr 28, 2026Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY, WHILE NAVIGATING AN EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: UNKNOWN) INTO POSITION, THE CATHETER DID NOT TRACK THROUGH THE ANATOMY AS EXPECTED. IN ADDITION, THE MID-SECTION OF THE CATHETER KINKED DURING THE PROCEDURE. THIS WAS CONFIRMED BY THE PHYSICIAN WHEN INSPECTING THE CATHETER AFTER THE OPERATION. THE TARGET DESTINATION FOR THE CATHETER WAS PETROUS INTERNAL CAROTID ARTERY (P-ICA) AND THE CATHETER KINKED WHILE TAKING THIS BEND. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-APR-2026 INDICATED THAT THE TARGET VESSEL/SITE WAS THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS NO RELEVANT ANATOMICAL INFORMATION INCLUDING VESSEL CHARACTERISTICS. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021059 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THROMBECTOMY PROCEDURE TARGETING THE RIGHT INTERNAL CAROTID ARTERY (ICA) LARGE VESSEL OCCLUSION (LVO), THE 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BGC) (BG8795U / 10060509) WAS USED WITH AN 80CM 8F ARROW SHEATH. THE PHYSICIAN REPORTED FEELING MORE FRICTION THAN USUAL INSERTING THE EMBOGUARD THROUGH THE ARROW SHEATH. THE SPLIT INTRODUCER WAS USED TO INSERT THE EMBOGUARD THROUGH THE HUB OF THE ARROW SHEATH, BUT THE PHYSICIAN REPORTED FRICTION THROUGHOUT THE INSERTION OF EMBOGUARD THROUGH THE ARROW SHEATH. DURING INFLATION OF THE EMBOGUARD BALLOON WITH THE LUER-ACTIVATED VALVE (LAV) AND 3CC SYRINGE, THE PHYSICIAN NOTICED THE BALLOON WAS NOT HOLDING INFLATION, EVEN WHEN REMOVING THE SYRINGE FROM THE LAV. THE PHYSICIAN THEN REINFLATED THE BALLOON AND NOTICED A SMALL LEAK ON THE ANGIOGRAM. THE EMBOGUARD BALLOON WAS KEPT DEFLATED AND THE THROMBECTOMY PROCEEDED TO SUCCESSFUL COMPLETION. THERE WERE NO PATIENT HARM AND NO SIGNIFICANT LOSS OF TIME. ON 14-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, A PEEL-AWAY SHEATH WAS USED. A DILATOR WAS ALSO USED AND THEN IT WAS REPLACED WITH AN ACCESS CATHETER. THE EMBOGUARD BALLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945933 ↗
• MalfunctionApr 13, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT AN ACUTE ISCHEMIC STROKE (AIS). THE EMBOGUARD 87, 95 CM (PRODUCT CODE: BG8795U, LOT NUMBER: 0000263518) WAS USED AS A BALLOON GUIDING CATHETER (BGC). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER PREPARATION, AN EMBOGUARD KINK OCCURRED DURING USE. THE EMBOGUARD WAS REPLACED WITH ANOTHER NEW BGC AND THE PROCEDURE WAS RESUMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PUNCTURE SITE WAS AT THE GROIN. THE TIMING OF THE KINK WAS WHEN THE INNER DEVICE WAS BEING WITHDRAWN. THE LOCATION OF THE CATHETER TIP WAS AT THE COMMON CAROTID ARTERY (CCA). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS PERFORMED. THE LESION WAS UNKNOWN. OTHER CONCOMITANT DEVICES WERE UNKNOWN. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-APR-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 24859558 ↗
• MalfunctionApr 9, 2026Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF RIGHT INTERNAL CAROTID ARTERY VIA FEMORAL APPROACH TO TREAT ACUTE ISCHEMIC STROKE. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EMBOGUARD 87, 95 CM BALLOON GUIDE CATHETER (PRODUCT CODE: BG8795U, LOT NUMBER: 9948491) WAS ADVANCED OVER A 0.035-INCH GUIDEWIRE AND A DIAGNOSTIC CATHETER AND THE EMBOGUARD WAS PLACED IN THE RIGHT COMMON CAROTID ARTERY. AFTER PERFORMING ANGIOGRAPHY, ATTEMPTED TO ADVANCE THE ASPIRATION CATHETER, BUT IT COULD NOT ADVANCE WITHIN THE EMBOGUARD. UNDER FLUOROSCOPY, THE EMBOGUARD WAS FOUND TO BE KINKED AT THE ORIGIN OF THE COMMON CAROTID ARTERY. THEREFORE, THE EMBOGUARD WAS REMOVED AND REPLACED WITH A COMPETITOR¿S BALLOON CATHETER. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS RIGHT COMMON CAROTID ARTERY. OTHER CONCOMITANT DEVICE WAS TRAK MICROCATHETER, RADIFOCUS 0.035 INCH. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2026 INDICATED THAT THERE WERE NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832337 ↗

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