ClotTriever Sheath, 16 Fr 51-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850291007123), received between Mar 18, 2025 and Jan 14, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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.

• InjuryJan 14, 2026Entrapment of Device; Material Separation

  ON (B)(6) 2025, A 58-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT UNDERWENT A PULMONARY EMBOLISM (PE) THROMBECTOMY TWO DAYS PRIOR. DURING THE DVT THROMBECTOMY, THE PATIENT WAS POSITIONED FROG LEGGED AND RESISTANCE WAS FELT PERFORMING THE MICROPUNCTURE DUE TO CHRONIC CLOT. AS THE CLOTTRIEVER SHEATH, 16 FR (CT SHEATH) ADVANCED, IT BECAME STUCK. WHEN THE CT SHEATH WAS PULLED BACK, THE FUNNEL SEPARATED FROM THE DEVICE. THE FUNNEL WAS SUCCESSFULLY REMOVED THROUGHVENOUS CUTDOWN.

  Patient problems: Vascular Dissection

  MAUDE report 24075270 ↗
• InjuryNov 12, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, A FEMALE PATIENT UNDERWENT BILATERAL POPLITEAL DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PREEXISTING LEFT LOWER EXTREMITY STENT THAT HAD OCCLUDED. DURING THE PROCEDURE, THE LEFT POPLITEAL VEIN WAS ACCESSED WITHOUT ISSUE USING THE CLOTTREIVER SHEATH, 16FR (CT SHEATH) AND REVCORE CATHETER. UPON MOVING TO THE RIGHT POPLITEAL VEIN, ACCESS WAS ATTEMPTED BY INSERTING THE CT SHEATH. INITIAL ATTEMPTS ON THE RIGHT SIDE ENCOUNTERED A NETWORK OF COLLATERAL VEINS. TWO SEPARATE ATTEMPTS APPEARED TO HAVE ENTERED A COLLATERAL BASED ON WIRE TRAJECTORY AND VENOGRAPHY. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT USED TO CONFIRM THE LOCATION. THE PROCEDURE CONTINUED WITHOUT ANY APPARENT INTRAPROCEDURAL COMPLICATIONS. NO THROMBECTOMY WAS PERFORMED THROUGH THE RIGHT SIDE ACCESS, ONLY DEPLOYMENT OF THE FLOWTRIEVER XL CATHETER DISKS. UPON REMOVAL OF THE CT SHEATH, AT THE CONCLUSION OF THE PROCEDURE, TISSUE RESEMBLING VEIN WALL WAS ADHERENT TO THE SHEATH. THE PHYSICIAN STATED THAT THE VESSEL MAY HAVE EXTERNALIZED WITH THE SHEATH REMOVAL, AND THE PHYSICIAN EXCISED THE TISSUE. THE ACCESS SITE WAS CLOSED WITH SUTURES AND MANUAL PRESSURE WAS HELD. THERE WAS NO

  Patient problems: Vascular Dissection

  MAUDE report 23538441 ↗
• InjuryMay 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 24-YEAR-OLD MALE PRESENTED WITH LEFT UPPER EXTREMITY SWELLING. HIS SYMPTOMS WERE CONSISTENT WITH THORACIC OUTLER SYNDROME AND THROMBUS WAS IDENTIFIED EXTENDING FROM THE BRACHIAL VEIN TO JUST PAST THE BRACHIOCEPHALIC VEIN. THE PLAN WAS TO GAIN BRACHIAL ACCESS AND TO USE THE 13 FR CLOTTRIEVER (CT) SHEATH. ACCESS WAS GAINED AND IMAGING WAS PERFORMED. THE PHYSICIAN THEN DECIDED TO PLACE THE 13 FR CT SHEATH. THE DILATOR WAS ADVANCED INTO THE VESSEL, BUT THE PATIENT EXPRESSED PAIN. UPON DEPLOYMENT OF THE FUNNEL, THE PAIN INCREASED. IMAGING WAS PERFORMED WHICH REVEALED THAT THE FUNNEL WAS NOT DEPLOYED AND THE IMAGING APPEARED UNUSUAL. THE DECISION WAS MADE TO REMOVE THE SHEATH, BUT THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN PULLED HARDER, AND THE SHEATH CAME OUT WITH VEIN ENCOMPASSING THE SHAFT. EXTRAVASATION WAS ALSO DISCOVERED. UPON INSPECTION, IT WAS REVEALED THAT A 16 FR CT SHEATH WAS USED INSTEAD OF A 13 FR. STASIS WAS OBTAINED AND THE PATIENT WAS DISCHARGED LATER THAT DAY. IT WAS REPORTED THAT THE PATIENT RETURNED TO WORK THE FOLLOWING MORNING BUT CALLED THE PHYSICIAN AND COMPLAINED OF PAIN. PLANS WERE MADE FOR THE PATIENT TO UNDERGO A RIB RESECTION.

  Patient problems: Vascular Dissection

  MAUDE report 22080457 ↗
• MalfunctionMay 22, 2025Entrapment of Device; Fracture; Material Deformation; Entrapment of Device; Fracture; Material Deformation

  ON (B)(6) 2025, AN 80-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT TWO DAYS. DURING THE THROMBECTOMY, THE CLOTTRIEVER SHEATH, 16 FR (CT SHEATH) WAS PLACED IN THE RIGHT POPLITEAL VEIN ACCESS SITE. THE FUNNEL ON THE CT SHEATH WAS DEPLOYED APPROPRIATELY BUT PRIOR TO RETRACTING THE DILATOR, THE SLIDES WERE PULLED TOWARDS TO PROXIMAL END. RESISTANCE WAS FELT, SO THE SLIDES WERE PUSHED BACK DOWN. RESISTANCE WAS FELT AGAIN, AND THE FUNNEL WAS OBSERVED DEFORMING ON IMAGING. AN ATTEMPT WAS MADE TO REMOVE THE SHEATH, BUT THE PATIENT'S SKIN WAS WRAPPED AROUND THE FUNNEL AND DILATOR. A LARGER SKIN NICK WAS PERFORMED, AND THE DILATOR AND FUNNEL WERE ABLE TO BE SEPARATED. UPON REMOVING THE DEVICE, THE FUNNEL WAS DEFORMED, AND THE DILATOR HAD CRACKED. THE MEDICAL TEAM OBSERVED THE AREA OF DISSECTION FOR SEVERAL MINUTES TO ENSURE THE AREA DID NOT GET LARGER. ONCE THE TEAM CONFIRMED THE AREA DID NOT GET WORSE AND THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION TO RESOLVE THE VESSEL INJURY, ANOTHER CLOTTRIEVER SHEATH, 16 FR WAS USED TO COMPLETE THE CASE.

  Patient problems: Vascular Dissection

  MAUDE report 22072464 ↗
• InjuryMar 18, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  A 56-YEAR-OLD MALE UNDERWENT A THROMBECTOMY USING THE INARI CLOTTRIEVER SYSTEM. WHILE USING FLOWSTASIS, THE OPERATOR FULLY TIGHTENED THE FLOWSTASIS BEFORE PULLING THE 16 FR. CLOTTRIEVER SHEATH BACK. AS IT WAS PULLED BACK, THE SHEATH FRACTURED. THIS LEFT ROUGHLY 1 CM OF THE PURPLE PORTION OF THE SHEATH AND THE ENTIRE FUNNEL STILL INSIDE THE PATIENT. A VENOUS CUTDOWN WAS PERFORMED SUCCESSFULLY TO REMOVE THE BROKEN PORTION. THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638930 ↗