EMBOTRAPRecalls & reported problems across all models

We found 5 models of EMBOTRAP by Neuravi Limited in the FDA's device registry (GUDID). Together they are named in 431 adverse event reports in the FDA's MAUDE database, received between Aug 23, 2018 and Sep 9, 2026 — classified as 37 deaths, 259 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (59 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 EMBOTRAP problems

EMBOTRAP models

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

• EMBOTRAP ET309537

  Catheter, Thrombus Retriever
  13 deaths177 reports
• Embotrap ET009533

  Catheter, Thrombus Retriever
  16 deaths153 reports
• EMBOTRAP ET309645

  Catheter, Thrombus Retriever
  5 deaths60 reports
• EMBOTRAP ET309522

  Catheter, Thrombus Retriever
  3 deaths34 reports
• Embotrap ET009521

  Catheter, Thrombus Retriever
  7 reports

Recent EMBOTRAP adverse event reports

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

• DeathSep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported, via a personal interaction, that an EMBOTRAP III 5 MM X 37 MM (ET309537/ 26A020AV) and a 132CM CEREGLIDE 71 CATHETER (NIC71132C/ 31867850) were used for a mechanical thrombectomy procedure to treat an occlusion at the M1 segment of the middle cerebral artery (MCA) for an acute ischemic stroke using combined technique. During the procedure, the thrombus was successfully retrieved and no malfunctions were reported. Although the thrombectomy was successful, it was discovered during a follow-up interview for the case that the patient had died. The physician commented that the event was not product-related, and that peripheral vessel rupture and hemorrhage occurred due to the hemodynamic load after reperfusion. Additionally, it was reported that the patient¿s advanced age and the large hemodynamic load from reperfusion likely contributed to vessel rupture.The event was initially reported as such, ¿The procedure was a mechanical thrombectomy of middle cerebral artery M1 to treat acute ischemic stroke with a combined technique using the Cereglide 71 and EmboTrap III 5x37. The devices were used according to IFU. Thrombectomy was performed following the standard procedural

  Patient problems: Intracranial Hemorrhage

  MAUDE report 50696981 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  The healthcare professional reported that during a mechanical thrombectomy procedure targeting an occlusion in the middle cerebral artery (MCA) at the M1-M2 bifurcation, the devices were used in accordance with their respective instructions for use (IFUs). It was reported that initially, a 132cm Cereglide 71 Intermediate Catheter (NIC71132U / lot# unknown) was used; however, distal embolism was observed. As a result, the procedure was continued using a combination of the Cereglide 71 intermediate catheter and a 144 cm Cereglide 42 Catheter (NIC42144C / lot# unknown). A 5mm x 22mm EmboTrap III Revascularization device (ET309522 / lot# unknown) was subsequently used to treat the residual thrombus. The thrombus was successfully retrieved, but post-operative imaging confirmed the presence of a hemorrhage. No additional intervention was performed. The patient is reported to be currently showing signs of recovery without additional intervention. It was not known whether a continuous flush was maintained during the procedure.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 50264946 ↗
• MalfunctionMay 15, 2026Material Separation

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY, SEGMENT M1 TO TREAT ACUTE ISCHEMIC STROKE AN EMBOTRAP III 5 MM X 22 MM (PRODUCT CODE: ET309522, LOT NUMBER: ET309522) WAS USED. RECANALIZATION WAS ACHIEVED WITHOUT PROBLEMS DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, CONFIRMATION WHETHER THE USED STENT HAD ANY DAMAGE OR SCRATCHES WAS REQUESTED. THE PHYSICIAN REQUESTED INVESTIGATION OF THE STENT AFTER USE, ALTHOUGH THE PROCEDURE ITSELF WAS COMPLETED WITHOUT ANY PRODUCT-RELATED 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. OTHER CONCOMITANT DEVICES WERE OPTIMO 9FR GUIDING CATHETER, CHIKAI NEXUS GUIDEWIRE, PHENOM MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2026 INDICATED THAT THERE WAS NO IMPACT ON THE PATIENT; HOWEVER, DURING THE FINAL ANGIOGRAPHY AT THE END OF THE PROCEDURE, A SHADOW LIKE FINDING WAS OBSERVED. ALTHOUGH IT WAS NOT LARGE ENOUGH TO BE DEFINITIVELY IDENTIFIED AS A FOREIGN BODY, THE PHYSICIAN SUSPECTED THAT IT MIGHT REPRESENT A FRAGMENT FROM ONE OF THE DEVICES USED DURING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187043 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/ 25L363AV) WAS USED FOR A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M2 (WITH TWO OCCLUSION SITES) TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A STROKE ¿SOME TIME AGO.¿ DURING THE PROCEDURE, SUCCESSFUL RECANALIZATION (TICI 3) WAS ACHIEVED WITH TWO PASSES; HOWEVER, A POSTOPERATIVE HEMORRHAGIC COMPLICATION WAS OBSERVED. THE PATIENT WAS LEFT WITH RESIDUAL NEUROLOGICAL DEFICITS. THE PHYSICIAN COMMENTED THAT IT WAS CONSIDERED UNLIKELY THAT THERE WAS A CAUSAL RELATIONSHIP WITH THE EMBOTRAP III DEVICE. POTENTIAL CAUSES OTHER THAN THE EMBOTRAP III WAS REPORTED AS ¿PROLONGED TIME FROM SYMPTOM ONSET AND THE PATIENT¿S ADVANCED AGE.¿ CONTINUOUS FLUSH WAS NOT DONE. OTHER DEVICES USED DURING THE PROCEDURE ARE UNKNOWN. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M2 OCCLUSION TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. THE DEVICES WERE USED ACCORDING TO IFU. THE TARGET WAS AN M2 OCCLUSION, WITH TWO OCCLUSION SITES IDENTIFIED. THE

  Patient problems: Intracranial Hemorrhage; Unspecified Nervous System Problem

  MAUDE report 24939558 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 37 MM (ET309537/25K286AV) WAS USED FOR A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY M1 OCCLUSION TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. DURING THE PROCEDURE, SUCCESSFUL RECANALIZATION (TICI 3) WAS ACHIEVED IN ONE PASS; HOWEVER, A POSTOPERATIVE HEMORRHAGIC COMPLICATION WAS OBSERVED. THE PATIENT WAS LEFT WITH RESIDUAL NEUROLOGICAL DEFICITS. NO FURTHER TREATMENT IS PLANNED. THE PHYSICIAN COMMENTED THAT ALTHOUGH IT IS UNCLEAR WHETHER THERE IS A CAUSAL RELATIONSHIP WITH EMBOTRAP III, A POSTOPERATIVE HEMORRHAGIC COMPLICATION WAS OBSERVED. POTENTIAL CAUSES OTHER THAN THE EMBOTRAP III WAS REPORTED AS "THE EFFECT OF TPA MAY BE CONSIDERED; HOWEVER, THIS REMAINS UNCERTAIN." CONTINUOUS FLUSH WAS NOT DONE. ANOTHER DEVICE USED DURING THE PROCEDURE WAS A CEREGLIDE71 INTERMEDIATE CATHETER. THE EVENT WAS INITIALLY REPORTED AS SUCH, "THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY M1 OCCLUSION TO TREAT CEREBRAL INFARCTION, WHICH WAS PERFORMED BY COMBINED TECHNIQUE. THE DEVICES WERE USED ACCORDING TO IFU. USING THE EMBOTRAP III WITH A COMBINED TECHNIQUE, SUCCESSF

  Patient problems: Intracranial Hemorrhage; Unspecified Nervous System Problem

  MAUDE report 24939345 ↗
• MalfunctionApr 2, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF MIDDLE CEREBRAL ARTERY IN TREATING MAJOR ARTERY OCCLUSION (ACUTE ISCHEMIC STROKE). THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER CROSSING THE LESION WITH A PHENOM 21 MICROCATHETER, THE EMBOTRAP III 5 MM X 37 MM (PRODUCT CODE: ET309537, LOT NUMBER: 25J206AV) WAS INSERTED, BUT RESISTANCE WAS ENCOUNTERED AND IT COULD NOT BE DELIVERED. THE EMBOTRAP III WAS THEN REPLACED WITH ANOTHER NEW EMBOTRAP III OF THE SAME PRODUCT CODE, AND IT WAS SUCCESSFULLY DELIVERED THROUGH THE SAME PHENOM 21. SUBSEQUENTLY, RECANALIZATION WAS ACHIEVED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT A CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WERE NO NOTABLE VESSEL CHARACTERISTICS. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. BASED ON THE PRODUCT ANALY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767592 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2026, THE 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31457320) AND TWO (2) 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537) FROM THE SAME LOT NUMBER (25B080AV) WERE USED. A VESSEL DISSECTION OCCURRED AT THE SITE WHERE THE 132CM CEREGLIDE 71 CATHETER AND THE EMBOTRAP III DEVICE WERE USED. THE PHYSICIAN OPINED THAT THERE IS A RELATIONSHIP BETWEEN THE DEVICES AND THE ADVERSE EVENT. THE PHYSICIAN MENTIONED THAT ¿THE POSSIBILITY THAT THE SELECTED SIZE OF THE EMBOTRAP III MAY HAVE BEEN TOO LARGE.¿ AT THE TIME OF THE COMPLAINT INITIATION, THE PATIENT¿S CLINICAL COURSE AND POST-PROCEDURE STATUS WAS REPORTED AS UNKNOWN. ON 08-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THE PATIENT¿S ORIGINAL PRESENTING SYMPTOMS WAS ¿ACUTE ISCHEMIC STROKE.¿ IT IS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24547473 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2026, THE 132CM CEREGLIDE 71 CATHETER (NIC71132C / 31457320) AND TWO (2) 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537) FROM THE SAME LOT NUMBER (25B080AV) WERE USED. A VESSEL DISSECTION OCCURRED AT THE SITE WHERE THE 132CM CEREGLIDE 71 CATHETER AND THE EMBOTRAP III DEVICE WERE USED. THE PHYSICIAN OPINED THAT THERE IS A RELATIONSHIP BETWEEN THE DEVICES AND THE ADVERSE EVENT. THE PHYSICIAN MENTIONED THAT ¿THE POSSIBILITY THAT THE SELECTED SIZE OF THE EMBOTRAP III MAY HAVE BEEN TOO LARGE.¿ AT THE TIME OF THE COMPLAINT INITIATION, THE PATIENT¿S CLINICAL COURSE AND POST-PROCEDURE STATUS WAS REPORTED AS UNKNOWN. ON 08-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THE PATIENT¿S ORIGINAL PRESENTING SYMPTOMS WAS ¿ACUTE ISCHEMIC STROKE.¿ IT IS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24547467 ↗
• MalfunctionFeb 18, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A MECHANICAL THROMBECTOMY OF THE MIDDLE CEREBRAL ARTERY IN TREATING CEREBRAL INFARCTION. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER ADVANCING THE EMBOTRAP III 5 MM X 37 MM (PRODUCT CODE: ET309537, LOT NUMBER: 23B146AV), CROSSED THE LESION USING A CEREGLIDE 71 CATHETER AND A PHENOM 21 MICROCATHETER (MC). THEN ATTEMPTED TO INSERT THE EMBOTRAP III INTO THE MICROCATHETER BUT FELT RESISTANCE AROUND THE HUB AND WERE UNABLE TO ADVANCE IT. THE EMBOTRAP III WAS REPLACED WITH A TIGERTRIEVER THROMBECTOMY DEVICE AND USED THE SAME MICROCATHETER. HOWEVER, IT COULD NOT BE INSERTED, SO THE PROCEDURE WAS CONTINUED. THROMBUS WAS RETRIEVED IN ONE PASS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO POST-PROCEDURE CHANGES IN THE PATIENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE EMBOGUARD GUIDING CATHETER, PHENOM MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-FEB-2026 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THERE WAS NO CONSPICUOUS CALCIFICATION OR BEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378763 ↗
• DeathFeb 17, 2026Lack of Effect

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/ LOT # UNKNOWN), A GEOMETRIC CLOT EXTRACTOR 4.5 X (GCE4528/ 25J188AV), AND A CEREGLIDE57 INTERMEDIATE CATHETER (PRODUCT CODE/ LOT # UNKNOWN) WERE USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, A TOTAL OF FIVE PASSES WERE PERFORMED BUT RECANALIZATION WAS NOT ACHIEVED, AND THE PROCEDURE WAS CANCELLED WITH TICI 0 (COMPLETE OCCLUSION). POSTOPERATIVE CT SHOWED A FAINT HEMORRHAGE, AND THE PATIENT WAS KEPT FOR INPATIENT OBSERVATION. APPROXIMATELY SEVEN DAYS AFTER THE PROCEDURE THE HEMORRHAGE EXPANDED; NEUROSURGERY PHYSICIAN PERFORMED EXTERNAL DECOMPRESSION THERAPY. THE PATIENT ULTIMATELY PASSED AWAY DUE TO SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THE PHYSICIAN JUDGED THAT THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S OUTCOME AND THE DEVICES USED. THE PHYSICIAN FURTHER COMMENTED THAT ¿ALTHOUGH THE POSTOPERATIVE BLEEDING WAS MINOR, THIS IS A RARE CASE THAT WORSENED AFTER SURGERY. THE REASON FOR THE DETERIORATION IS UNKNOWN. EMBOTRAP AND NIMBUS WERE EACH USED, BUT THERE WAS NO VESSEL STRAIGHTENING OR RESISTANCE DURING TRACTION. IT IS POSSIBLE THAT PERFORMING FIVE PASSES WITH STENT RETRIEVER

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24364882 ↗
• MalfunctionJan 21, 2026Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY TO TREAT AN ACUTE ISCHEMIC STROKE (AIS) EVENT, DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS). DURING THE INSERTION OF THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / 25J055AV), RESISTANCE WAS FELT AT THE HUB OF THE CONCOMITANT HEADWAY® MICROCATHETER (TERUMO NEURO). CONTINUOUS FLUSH WAS MAINTAINED. UPON REMOVAL, THE STENT BODY WAS FOUND TO BE DEFORMED. THE EMBOTRAP III DEVICE WAS REPLACED, ¿WHICH COULD BE USED WITH THE SAME MICROCATHETER WITHOUT ANY PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.¿ THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 18-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPLACEMENT STENT WAS ANOTHER 5MM X 37MM EMBOTRAP III (ET309537).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24137905 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, VIA PERSONAL INTERACTION, THAT AN EMBOTRAP III 5 MM X 22 MM (ET309522/ LOT # UNKNOWN) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE DISTAL M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE EMBOTRAP III DEVICE WAS USED TO TREAT A DISTAL M2 MIDDLE CEREBRAL ARTERY OCCLUSION. AN INITIAL ATTEMPT TO TREAT A MIDDLE CEREBRAL ARTERY (M1) OCCLUSION WAS MADE USING CEREGLIDE71 WITH THE ADAPT TECHNIQUE (A DIRECT ASPIRATION, FIRST PASS TECHNIQUE). ANGIOGRAPHY DEMONSTRATED OCCLUSIONS IN M2 PROXIMAL AND M2 DISTAL. THE THROMBUS IN M2 PROXIMAL WAS RETRIEVED USING NIMBUS. FOR THE THROMBUS IN M2 DISTAL, BECAUSE THE VESSEL DIAMETER WAS SMALL (APPROXIMATELY 1.3 MM), THE EMBOTRAP III WAS USED WITH ONLY ONE SEGMENT DEPLOYED; BLEEDING WAS OBSERVED AT THAT TIME. FINAL ANGIOGRAPHY WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT THE EMBOTRAP IS INDICATED FOR VESSELS = 1.5 MM AND THAT USING IT IN A 1.3 MM VESSEL MIGHT HAVE CAUSED THE BLEEDING. THE PATIENT¿S CONDITION IS UNKNOWN. CONTINUOUS FLUSH WAS UNKNOWN. THE LESION WAS MIDDLE CEREBRAL ARTERY M2 DISTAL. ANOTHER CONCOMITANT DEVICES WERE TRAK MICROCATHETER (STRYKER) AND CEREGLIDE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23992285 ↗
• MalfunctionDec 3, 2025Difficult to Remove; Lack of Effect; Difficult to Remove; Lack of Effect

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH STRONG VESSEL DEVIATION, A TOTAL OF 7 PASSES WERE MADE. THEY ARE DOCUMENTED AS FOLLOWS: THE FIRST PASS WAS VIA AN ADAPT (DIRECT ASPIRATION FIRST PASS TECHNIQUE) USING A 0.060-INCH ACCESS CATHETER. ¿MUCH RESISTANCE WAS NOT FELT, BUT THE PHYSICIAN WAS HESITANT TO INSERT THE CATHETER [INTO THE] M2, SO ASPIRATION WAS MADE AFTER COMPLETELY REMOVING THE MICROCATHETER.¿ THREE PASSES WERE MADE VIA THE COMBINED TECHNIQUE WITH THE 0.060-INCH ACCESS CATHETER AND THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / LOT# UNKNOWN). STRONG RESISTANCE WAS FELT. THE FIFTH PASS WAS VIA THE COMBINED TECHNIQUE USING A 0.046-INCH ACCESS CATHETER AND THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE. STRONG RESISTANCE WAS FELT. THE SIXTH PASS, THE EMBOTRAP III WAS PULLED BACK WITH THROMBI INTO THE ACCESS CATHETER. ¿AT THIS TIME, DEPLOYED THE EMBOTRAP III SHORTER AND ATTEMPTED TO OVERCOME THE RESISTANCE AND THE VESSEL DEVIATION, BUT COULD NOT ACHIEVE RECANALIZATION.¿ ON THE SEVENTH PASS, THE ¿EMBOTRAP III WAS PULLED BACK WITH THROMBI I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709846 ↗
• MalfunctionNov 21, 2025Difficult to Remove; Difficult to Remove

  A HEALTHCARE PROFESSION REPORTED THAT THIS WAS A MECHANICAL THROMBECTOMY OF A MIDDLE CEREBRAL ARTERY, SEGMENT M1 DISTAL OCCLUSION FOR CEREBRAL INFARCTION. THE ASPIRATION CATHETER (UNKNOWN COMPETITOR'S PRODUCT) COULD ONLY BE ADVANCED TO THE IC TOP, AND THE EMBOTRAP III 5 MM X 37 MM (ET309537, 23E097AV) WAS INSERTED AND DEPLOYED FROM M2. WHEN THE EMBOTRAP III DELIVERY WIRE WAS PULLED, IT COULD BE PULLED WITHOUT RESISTANCE FIRST, BUT WHEN THE DISTAL BASKET REACHED AT M1, STRONG RESISTANCE WAS FELT AND COULD NOT PULL FURTHER. THE TRAK21 MICROCATHETER (MC) WAS ADVANCED OVER THE EMBOTRAP III AND ATTEMPTED TO RE-SHEATH, BUT THE MC COULD NO LONGER BE ADVANCED BEYOND THE M1 MIDDLE. INSTEAD, WHEN THE ASPIRATION CATHETER WAS ADVANCED DISTALLY AGAIN, THE RESISTANCE WAS RESOLVED AND COULD BE REMOVED. THE THROMBUS WAS RETRIEVED, AND RECANALIZATION WAS OBTAINED. NO BLEEDING WAS FOUND. THE VESSEL WAS SEVERELY TORTUOUS. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT NOR BLEEDING. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-DEC-2023 AND 26-DEC-2023 INDICATED THAT RESISTANCE WAS ENCOUNTERED AT THE DISTAL BASKET WHEN REACHED THE M1 SEGMENT. THE DEVICE WAS STU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622470 ↗
• MalfunctionOct 31, 2025Failure to Advance; Failure to Advance

  ON 31-AUG-2025, THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE THERE WAS ISSUE WITH THE USE OF AN EMBOTRAP DEVICE. ADDITIONAL INFORMATION IS PENDING. ON 04-SEP-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE DISTAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). A 125CM CEREGLIDE 71 INTERMEDIATE CATHETER WAS USED AS ASPIRATION CATHETER WITH AN ENVI¿-SR (NEUROVASC TECHNOLOGIES) AND A SOLITAIRE¿ REVASCULARIZATION DEVICE (MEDTRONIC) WERE USED. AFTER SEVERAL PASSES, THE THROMBUS COULD NOT BE REMOVED AND THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / 25D152AV) WAS USED. WHEN THE EMBOTRAP III DEVICE WAS INSERTED INTO THE CONCOMITANT PHENOM ¿ 21 CATHETER (MEDTRONIC), THE EMBOTRAP III BECAME STUCK AND COULD NOT BE DELIVERED, RENDERING IT UNUSABLE. THE PROCEDURE WAS ABORTED WITH TICI SCORE OF 1. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. PRELIMINARY PHOTOS OF THE DEVICE WERE ADDED TO THE COMPLAINT ON 07-SEP-2025. ON 08-SEP-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE TARGET WAS AN OCCLUSION IN THE DISTAL M1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439757 ↗

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