VenaCore Thrombectomy Catheter AS-01160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850291007406), received between Jun 21, 2024 and Aug 14, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Break; Break

  ON (B)(6) 2025, A 46-YEAR-OLD FEMALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT TWO DAYS. WHILE PREPPING THE VENACORE CATHETER, A BROKEN STRUT ON THE CORING ELEMENT WAS OBSERVED. THE DEVICE WAS NOT USED IN THE PROCEDURE. A NEW DEVICE WAS OPENED AND THE THROMBECTOMY WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806270 ↗
• MalfunctionApr 22, 2025Break; Break

  ON (B)(6) 2025, A 63-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT 28 DAYS. AT THE END OF THE THROMBECTOMY, WHILE THE VENACORE CATHETER (VENACORE) WAS BEING PREPPED FOR THE SIXTH CATHETER PASS, A STRUT ON THE CORING ELEMENT WAS NOTED BROKEN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT AND ALL DEVICES AND COMPONENTS WERE COMPLETELY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886782 ↗
• MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A 63-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT 19 DAYS. DURING THE THROMBECTOMY, THE CORING ELEMENT OF THE VENACORE CATHETER (VENACORE) WAS NOT FULLY COLLAPSED WHILE REMOVING FROM THE PATIENT, WHICH RESULTED IN ADDITIONAL FORCE USED TO REMOVE THE DEVICE FROM THE PATIENT. UPON REMOVAL OF THE VENACORE FROM THE PATIENT, THE MEDICAL TEAM NOTICED A STRUT ON THE CORING ELEMENT HAD BROKEN OFF. NOTHING WAS LEFT INSIDE THE PATIENT, AND THE PATIENT DID NOT ENDURE ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699673 ↗
• InjuryJan 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 65-YEAR-OLD FEMALE PRESENTED WITH LEFT LOWER EXTREMITY PAIN AND SWELLING FOR THE PAST 4 DAYS. THE PATIENT WAS NOTED TO HAVE A HISTORY OF DEEP VEIN THROMBOSIS (DVT) 20 YEARS PRIOR. A DUPLEX ULTRASOUND WAS PERFORMED WHICH REVEALED LEFT ILIOFEMORAL DVT. PRE-CASE PLANNING DECIDED TO USE THE CLOTTRIEVER BOLD (CT BOLD) AND CLOTTRIEVER XL (CTXL). VENACORE WAS ALSO PLANNED TO BE USED TO ADDRESS ANY AREAS OF RESIDUAL CHRONIC THROMBUS. BILATERAL POPLITEAL ACCESS WAS OBTAINED AND VENOGRAMS WERE PERFORMED WHICH REVEALED LOWER LEFT EXTREMITY THROMBUS WITH EXTENSION INTO THE INFERIOR VENA CAVA. A CLOTTRIEVER 16 FR SHEATH WAS PLACED, AND THE CATHETERS WERE ADVANCED. 8 PASSES WERE PERFORMED WITH THE CT BOLD AND 2 WITH THE CTXL. A REPEAT VENOGRAM WAS PERFORMED WHICH REVEALED A FOCAL AREA BELOW THE COMMON FEMORAL VEIN. THE PHYSICIAN FELT IT WAS CHRONIC THROMBUS AND DEPLOYED THE VENACORE. 2 PASSES WERE PERFORMED WITH THE VENACORE BUT NO THROMBUS WAS REMOVED. THERE WERE SIGNS OF AN OCCLUSION IN THE SHEATH. THE PHYSICIAN PULLED THE MATERIAL OUT AND EXPRESSED THAT IT LOOKED LIKE A VEIN. THE SHEATH WAS RE-INSERTED, AND A REPEAT VENOGRAM WAS PERFORMED. THIS REVEALED EXTRAVASATION PROXIMAL TO THE SHEATH

  Patient problems: Vascular Dissection

  MAUDE report 21270261 ↗
• MalfunctionJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A MALE PATIENT WITH DEEP VEIN THROMBOSIS (DVT) UNDERWENT DVT THROMBECTOMY USING INARI DEVICES ON (B)(6) 2024. HE HAD A HISTORY OF DVT IN 2023. THE CLOT AGE WAS ESTIMATED AT 175 DAYS. PRIOR TO THROMBECTOMY, THE PHYSICIAN ATTEMPTED TO LOAD THE DEVICE ONTO THE GUIDEWIRE BUT NOTICED THE LUMEN WAS BLOCKED APPROXIMATELY 1MM INTO THE LUMEN. AS AN ATTEMPT TO TROUBLESHOOT, THE PHYSICIAN FLIPPED THE DEVICE AND INSERTED THE STIFF PROXIMAL END OF THE AMPLATZ SUPER STIFF GUIDEWIRE THROUGH THE PROXIMAL END OF THE VENACORE. IT WAS ADVANCED TO THE DISTAL TIP WHERE RESISTANCE WAS FELT AGAIN, THOUGH THE PHYSICIAN WAS ABLE TO BREAK THROUGH WITH FORCE. THE PROCEDURE CONTINUED UNEVENTFULLY USING THE VENACORE DEVICE AND AFTER THE EIGHTH PASS, THE PHYSICIAN OVER-SHEATHED THE TIP USING THE DELIVERY CATHETER. NO RESISTANCE WAS FELT AS THE PHYSICIAN CONTINUED TO PUSH FORWARD BEYOND WHERE THE TIP IS ANCHORED. THE TIP WAS PUSHED DISTALLY BY THE DELIVERY CATHETER AS IT DETACHED FROM THE INNER SHAFT. THE VENACORE CATHETER WAS REMOVED FROM THE PATIENT WHILE THE TIP REMAINED ON THE TREATMENT GUIDEWIRE, IN THE PATIENT'S BODY. THE PHYSICIAN WAS ABLE TO REMOVE THE TIP BY SNARING IT ON THE TREATMENT GUIDEWIRE AND REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585867 ↗