Embotrap ET009521Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704081319), received between Apr 21, 2020 and Nov 8, 2022 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE TO TREAT AN ISCHEMIC STROKE, THE PHYSICIAN WAS USING A 95CM EMBOGUARD 87 BALLOON GUIDE CATHETER (BG8795U / 0000148668) AS A BASE CATHETER AND AN ACE¿ 60 REPERFUSION CATHETER (PENUMBRA) TO ASPIRATE THE CLOT IN THE CLOTTED TARGET VESSEL. DURING THE INTERVENTION, THE ACE 60 CATHETER ¿STRETCHED.¿ A SECOND ONE WAS USED AND IT ALSO BECAME ¿STRETCHED.¿ A 5MM X 21MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009521 / 20H086AV) WAS THEN USED. IT WAS REPORTED THAT THE EMBOTRAP II DEVICE WOULD NOT ADVANCE THROUGH A HEADWAY® 21 MICROCATHETER (MICROVENTION). A HEADWAY® 27 MICROCATHETER (MICROVENTION) WAS THEN OPENED AND THE EMBOTRAP II DEVICE WAS USED SUCCESSFULLY. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT INDICATED THAT THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. ON 02-NOV-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE LOT NUMBER PROVIDED FOR THE EMBOTRAP DEVICE IS 20H086AV. THE LOT NUMBER ASSOCIATED WITH THE EMBOGUARD BALLOON CATHETER IS 0000148668. THE INFORMATION INDICATED THAT IT WAS UNKNOWN IF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15753814 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY, A 53-YEAR-OLD FEMALE (SUBJECT 765-034) WITH A HISTORY OF ISCHEMIC STROKE, HYPERTENSION, MYOCARDIAL INFARCTION, AND MITRAL VALVE REPLACEMENT WITH A WITNESSED STROKE ON (B)(6) 2019 WITH AN MTICI SCORE OF 0, NIHSS SCORE OF 27, AND MRS SCORE OF 0. THE PATIENT UNDERWENT AN ENDOVASCULAR MECHANICAL THROMBECTOMY USING A 5MM X 21MM EMBOTRAP II (ET009521/18J091AV) DEVICE ON (B)(6) 2019. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS CARDIOEMBOLIC. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF STROKE PRESENTATION. THE EMBOTRAP DEVICE WAS ATTEMPTED TO BE USED AS THE FIRST LINE OF TREATMENT IN THIS SUBJECT FOR INTRACRANIAL CLOT REMOVAL. THE FIRST, SECOND, AND THIRD PASSES WERE MADE WITH THE EMBOTRAP II DEVICE AT THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) (3 MIN INCUBATION) RESULTING IN AN MTICI SCORE OF 2B WITH NO CLOT RETRIEVAL. NO FURTHER PASSES WERE MADE. ALL THREE PASSES WERE MADE USING A 0.027 MARKSMAN MICROCATHETER (MEDTRONIC), A 9 CELLO (MEDTRONIC), AND A 0.068 ACE INTERMEDIATE CATHETER (PENUMBRA). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A PERFORATION IN THE DISTAL BRANCH OF THE MIDDLE CEREBRAL ARTERY

  Patient problems: Perforation of Vessels

  MAUDE report 15233595 ↗
• MalfunctionJun 10, 2021Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A STROKE MECHANICAL THROMBECTOMY PROCEDURE, AN EMBOTRAP II 5X33 REVASCULARIZATION DEVICE (ET009533, 20L067AV) WAS BEING USED TO REMOVE THE CLOT. UPON REMOVAL OF THE DEVICE FROM THE PATIENT, WHEN INSPECTING THE CLOT, THE PHYSICIAN NOTICED THAT THE END OF THE EMBOTRAP II DEVICE HAD PARTIALLY UNRAVELED. THE PROCEDURE WAS SUCCESSFUL AND BLOOD FLOW WAS RESTORED TO THE VESSEL. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SYSTEM WAS USED WITH THE RECOMMENDED UNSPECIFIED MICROCATHETER (MC). THERE WAS NO DIFFICULTY WITHDRAWING THE DEVICE. THERE WAS NO DIFFICULTY WITHDRAWING THE DEVICE FROM THE THROMBUS OR BACK THROUGH THE VESSEL. NO EXCESSIVE FORCE WAS APPLIED TO PULL THE DEVICE INTO THE CATHETER FOR WITHDRAWAL. ONLY ONE PASS WAS MADE TO ATTEMPT TO RETRIEVE THE CLOT. THERE WAS NO RESISTANCE ENCOUNTERED AT ANY TIME DURING THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974566 ↗
• InjuryApr 20, 2021Entrapment of Device; Premature Separation; Entrapment of Device; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR ACUTE ISCHEMIC STROKE, THE PHYSICIAN DEPLOYED A 7-10 X 30 ACCULINK (ABBOTT) STENT WHILE THE 5MM X 21MM EMBOTRAP II (ET009521/19K109AV) REVASCULARIZATION DEVICE WAS STILL IN PLACE; WHEN SHE ATTEMPTED TO PULL THE EMBOTRAP THROUGH THE STENT, THE EMBOTRAP DEVICE GOT SNAGGED ON THE STENT AND BROKE OFF. THE REPORTING SALES REPRESENTATIVE BELIEVES THAT THE CAGE DETACHED FROM THE DELIVERY SYSTEM. THE EMBOTRAP CAGE WAS LEFT IN THE PATIENT AND STENTED TO THE RIGHT INTERNAL CAROTID ARTERY (ICA). NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PHYSICIAN COMMENTED THAT THE ACCULINK STENT MAY NOT HAVE BEEN PROPERLY DEPLOYED IN THE VESSEL AND THAT MAY HAVE CONTRIBUTED TO THE EMBOTRAP DEVICE BECOMING SNAGGED ON THE STENT. THE HOSPITAL IS RETAINING THE DEVICE TO PERFORM THEIR OWN INVESTIGATION BUT WILL RELEASE IT FOR RETURN ONCE THEIR INVESTIGATION IS COMPLETE. ADDITIONAL INFORMATION IS PENDING AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693634 ↗
• MalfunctionFeb 8, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 5MM X 21MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009521 / 19G043AV) WAS USED IN A STROKE PROCEDURE WITH THE TARGET OCCLUSION ON THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT IS A (B)(6) FEMALE WITH TYPICAL ANATOMY. THE PHYSICIAN WAS USING THE EMBOTRAP II DEVICE WITH THE .027" ID MARKSMAN (TM) MICROCATHETER (MEDTRONIC), HOWEVER, HE WAS UNABLE TO ADVANCE THE EMBOTRAP II DEVICE OUT OF THE MICROCATHETER. THIS RESULTED IN THE PHYSICIAN HAVING TO REMOVE THE MICROCATHETER WITH THE EMBOTRAP II DEVICE STUCK INSIDE ITS LUMEN AND AS A RESULT LOST ACCESS ACROSS THE CLOT. THE PHYSICIAN REPORTED THAT HE FOUND IT INITIALLY EASY TO ADVANCE THROUGH THE MICROCATHETER, BUT IT BECAME VERY HARD TO ADVANCE IN THE CAVERNOUS SEGMENT. THE PHYSICIAN STATED THAT HE DID NOT FIND IT VERY NEGOTIABLE THROUGH CURVES AND BENDS. THE REPORTED ISSUE RESULTED IN THE CASE TAKING SEVERAL MORE MINUTES THAN IT HAD TO. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JANUARY 2021, INDICATED THAT THERE WAS NO RESISTANCE BETWEEN THE MARKSMAN MICROCATHETER AND THE INTERMEDIATE REACT" 68 CATHETER (M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294766 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE EXCELLENT STUDY, A (B)(6)-YEAR-OLD FEMALE (SUBJECT (B)(4)) WITH A HISTORY OF ISCHEMIC STROKE (1995), HYPERLIPIDEMIA, HYPERTENSION, PREVIOUS CORONARY ARTERY BYPASS GRAFTING (CABG), SMOKING (PREVIOUS), ARTHRITIS, AND CLASS 1 OBESITY (BMI 32 KG/M2) EXPERIENCED AN IN-HOSPITAL WITNESSED STROKE ON (B)(6) 2020 WITH MTICI SCORE OF 0, NIHSS SCORE OF 26, AND MRS SCORE OF 0 AND EXPERIENCED SEVERE RE-OCCLUSION OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) ON THE SAME DAY. THE EVENT RESOLVED ON THE SAME DAY WITH UNSPECIFIED MEDICATION AND CEREBRAL ANGIOGRAM WITH EMBOLECTOMY. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY USING A 5X21 EMBOTRAP II (ET009521/19K109AV) DEVICE ON (B)(6) 2020. THE SUSPECTED ORIGIN OF EMBOLISM WAS CARDIOEMBOLIC. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED. THE FIRST PASS MADE WITH THE EMBOTRAP AND MECHANICAL PUMP ASPIRATION AT LEFT M1 SEGMENT OF THE MCA (2 MIN INCUBATION) RESULTED IN MTICI SCORE OF 3 WITH CLOT RETRIEVAL VIA THE PUMP. NO FURTHER PASSES WERE MADE. THE EMBOTRAP PASS WAS MADE WITH AN 0.090¿ CEREBASE DA CATHETER WIT

  Patient problems: Obstruction/Occlusion

  MAUDE report 10265044 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE EXCELLENT STUDY; THE (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) PRESENTED WITH A WITNESSED STROKE ON (B)(6) 2019. THE MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE OF 0, NIHSS SCORE OF 26, AND A MODIFIED RANKIN SCORE (MRS) OF 0. THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY USING THE 5MM X 21MM EMBOTRAP II REVASCULARIZATION DEVICE (ET009521 / 18J091AV) ON THE SAME DAY. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS NOT ADMINISTERED AT THE TIME OF THE STROKE PRESENTATION. THE FIRST PASS MADE WITH THE EMBOTRAP II DEVICE WAS WITH A 0.072¿ INNER DIAMETER (ID) VIA A 0.025¿ ID MICROCATHETER AND MECHANICAL PUMP ASPIRATION AT RIGHT M1 (2 MIN INCUBATION) RESULTED IN MTICI SCORE OF 3 WITH FULL CLOT RETRIEVAL VIA THE EMBOTRAP. NO FURTHER PASSES WERE MADE. THE PATIENT EXPERIENCED A RE-OCCLUSION OF THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) ON THE FOLLOWING DAY, (B)(6) 2019, WHICH NECESSITATED MECHANICAL THROMBECTOMY AND THE EVENT RESOLVED WITH SEQUELAE ON THE SAME DAY. THE SUSPECTED ORIGIN OF THE EMBOLISM WAS LARGE-ARTERY DISEASE. THE 24-HOUR POST-PROCEDURE NIHSS SCORE WAS 8. THE PATIENT WAS

  Patient problems: No Code Available; Obstruction/Occlusion

  MAUDE report 9981713 ↗