ClotTriever Sheath, 13 FrRecalls & reported problems across all models

We found 2 models of ClotTriever Sheath, 13 Fr by Inari Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2017 and Aug 25, 2026 — classified as 3 deaths, 19 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (9 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 ClotTriever Sheath, 13 Fr problems

ClotTriever Sheath, 13 Fr models

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

• ClotTriever Sheath, 13 Fr 50-101

  Catheter, Embolectomy
  3 deaths24 reports
• ClotTriever Sheath, 13 Fr AS-01261/ 50-101

  Peripheral Mechanical Thrombectomy With Aspiration
  2 reports

Recent ClotTriever Sheath, 13 Fr adverse event reports

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

• InjuryAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439779 ↗
• InjuryApr 1, 2026Entrapment of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE CLOTTRIEVER SYSTEM OF DEVICES. WHEN INSERTING THE SHEATH INTO THE LEFT POPLITEAL VEIN, THE FUNNEL DID NOT FULLY OPEN. AS SUCH, AN 8 X 40 BALLOON WAS USED TO EXPAND THE FUNNEL SUCCESSFULLY. THE REMAINDER OF THE CASE WAS PERFORMED THE USUAL WAY PERFORMING A TOTAL OF 3 PASSES. AFTER THE PASSES, AN IVUS CATHETER WAS USED TO DETERMINE CLOT CLEARANCE AND LOOK FOR COMPRESSION OF THE LEFT COMMON ILIAC VEIN. A COMPRESSION WAS NOTED AND THE PHYSICIAN DETERMINED HE WILL STAGE IT AND BRING BACK ANOTHER TIME. A FIGURE 8 SUTURE WAS PERFORMED AROUND THE SHEATH AND FLOWSTASIS WAS ENGAGED FOR REMOVAL OF SHEATH. ATTEMPTING TO REMOVE THE SHEATH WAS NOT SUCCESSFUL, AS THE SHEATH WOULD NOT COME OUT. USE OF HEPARINIZED SALINE TO COAT THE SHEATHS HYDROPHILIC COATING WAS ATTEMPTED, SKIN NICK WAS ATTEMPTED, AND INSERTING DILATOR WHILE ATTEMPTING TO REMOVE WAS ATTEMPTED. SEVERAL VENOGRAMS WERE PERFORMED TO VISUALIZE THE FUNNEL AND VEIN. THE FUNNEL AND VEIN APPEARED NORMAL IN IMAGING. THE PATIENT WAS HAVING PAIN DURING THE REMOVAL ATTEMPTS. A VASCULAR SURGEON WAS CALLED TO THE ROOM AND DETERMINED THE PATIENT NEEDED A CUTDOWN OF THE POPLIT

  Patient problems: Pain

  MAUDE report 24756218 ↗
• InjuryMar 20, 2026Entrapment of Device; Detachment of Device or Device Component

  ON (B)(6) 2026 A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING STRYKER PERIPHERAL VASCULAR DEVICES. A TOTAL OF SIX PASSES WERE PERFORMED USING THE CLOTTRIEVER CATHETER (CT CATHETER) THROUGH THE CLOTTRIEVER SHEATH, 13FR (CT SHEATH). FOLLOWING THE SIXTH PASS, THE CT CATHETER WAS REMOVED AND WHILE REMOVING THE CT SHEATH, IT WAS NOTICED THAT THE FUNNEL WAS SEPARATED FROM THE SHEATH AND REMAINED SUBCUTANEOUS. THE FUNNEL WAS SURGICALLY REMOVED.

  Patient problems: Vascular Dissection

  MAUDE report 24653547 ↗
• MalfunctionMar 4, 2026Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT THROMBECTOMY USING THE CLOTTRIEVER SYSTEM OF DEVICES. DURING THE PROCEDURE, A CLOTTRIEVER SHEATH HEMOSTASIS VALVE SEPARATED FROM THE REST OF THE CATHETER. ADDITIONAL PRODUCT WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS OR INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508355 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. DURING THE PROCEDURE, THE CLOTTRIEVER SHEATH, 13 FR. (CT SHEATH) WAS REMOVED FROM THE PATIENT TO FLUSH THE DEVICE AND THEN WAS REINTRODUCED INTO THE PATIENT. AFTER REINSERTION, THE CT SHEATH WAS PULLED BACK A FEW CENTIMETERS AND THE HEMOSTASIS VALVE SEPARATED FROM THE SHEATH SHAFT. WIRE ACCESS WAS STILL MAINTAINED. THE PHYSICIAN PERFORMED A LARGER SKIN NICK AND THE SHEATH SHAFT WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT'S VASCULATURE USING HEMOSTATS. THE SHEATH SHAFT AND FUNNEL REMAINED INTACT. THE PROCEDURE WAS RESUMED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507757 ↗
• InjuryMar 3, 2026Entrapment of Device; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE CLOTTRIEVER SYSTEM OF DEVICES. ACCESS VIA GUIDEWIRE WAS ESTABLISHED. THE CLOTTRIEVER SHEATH WAS INSERTED. THE PROCEDURE WAS GOING SMOOTHLY UNTIL THE PATIENT FELT PAIN. X-RAY WAS UTILIZED TO OBTAIN VISUALIZATION AND A CLINICAL SUPPORT STAFF MEMBER NOTICED THE END OF THE SHEATH¿S FUNNEL WAS SLIGHTLY CURVED. THE PATIENT WAS SUPINE, IN A FROG-LEG POSITION. THE DOCTOR DECIDED TO REMOVE THE CLOTTRIEVER SHEATH TO CHECK IT. THERE WAS NOT MUCH RESISTANCE FELT BY THE SURGEON WHEN REMOVING THE SHEATH, BUT UPON INSPECTION, THE FUNNEL WAS MISSING. THE DOCTORS PERFORMED A VENOUS CUTDOWN TO REMOVE THE FUNNEL AND THEN CLOSED THE RIGHT POPLITEAL ACCESS.

  Patient problems: Foreign Body Embolism; Vascular Dissection

  MAUDE report 24501599 ↗
• InjuryOct 23, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 62-YEAR-OLD MALE UNDERWENT A SUCCESSFUL DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING THE INARI CLOTTRIEVER SYSTEM. APPROXIMATELY TWO MONTHS AFTER, ON (B)(6) 2025, THE PATIENT PRESENTED WITH A SECOND DVT AFTER HE HAD STOPPED TAKING HIS MEDICATION, ELIQUIS, AND REOCCLUDED. DURING THE VISIT ON (B)(6) 2025, IT WAS IDENTIFIED THAT THE PATIENT HAD A SEGMENT OF A CLOTTRIEVER SHEATH, 13 FR IN HIS POPLITEAL VEIN, SPECIFICALLY THE FUNNEL AND SMALL PART OF THE CATHETER. THE DECISION WAS MADE NOT TO REMOVE THE FUNNEL AS REMOVING IT MAY CAUSE MORE TRAUMA.

  Patient problems: Foreign Body In Patient

  MAUDE report 23375000 ↗
• InjuryJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B(6), 2025 A MALE PATIENT UNDERWENT A DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 10 DAYS OLD. DURING THE THROMBECTOMY, THE PATIENT WAS POSITIONED FROG-LEGGED. A CLOTTRIEVER SHEATH, 13 FR (CT SHEATH) WAS USED TO INSERT THE DEVICES. DURING THE PROCEDURE, THE SHEATH SHAFT SEPARATED FROM THE CT SHEATH HEMOSTASIS VALVE WITH THE PROXIMAL TIP PROTRUDING FROM THE ACCESS SITE. DUE TO THE PATIENT'S POSITIONING, THE MEDICAL TEAM DID NOT NOTICE THE SHEATH WAS LEAKING BLOOD IMMEDIATELY. AS A RESULT OF THE BLOOD LOSS, THE PATIENT'S HEMOGLOBIN DROPPED FROM 12G/DL TO 9G/DL, HOWEVER THE PATIENT DID NOT SHOW SIGNS OF DETERIORATION. THE PATIENT REMAINED STABLE, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUES AFTER THE CT SHEATH WAS REPLACED. POST PROCEDURE, THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO THE HEMOGLOBIN DROP AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) TO RECOVER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22470686 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 24-YEAR-OLD MALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT WAS BEING TREATED FOR TESTICULAR CANCER AND A HISTORY OF PULMONARY EMBOLISM THAT WAS TREATED IN (B)(6) 2025. THE PATIENT HAD A MASS IN HIS LEFT COMMON ILIAC, WHICH TOTALLY OCCLUDED THE VEIN. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 60 DAYS. EXTRAVASATION WAS OBSERVED AFTER THE CLOTTRIEVER SHEATH, 13FR (CT SHEATH) WAS INSERTED INTO THE PATIENT'S LEFT POPLITEAL VEIN AND AN ATTEMPT WAS MADE TO ADVANCE THE CLOTTRIEVER BOLD. THE MEDICAL TEAM MADE THE DECISION TO USE THE PATIENT'S INTERNAL JUGULAR VEIN AS AN ACCESS SITE. WHILE THE NEW CT SHEATH WAS BEING PLACED INTO THE PATIENT'S INTERNAL JUGULAR, THE MEDICAL TEAM NOTICED THE DILATOR WAS BENDING WHILE BEING INSERTED. THE CT SHEATH WAS ADVANCED, AND THE FUNNEL WAS DEPLOYED. A VENOGRAM SHOWED SOME EXTRAVASATION. AN ATTEMPT WAS MADE TO TRACK A BALLOON OVER THE WIRE; HOWEVER, THE BALLOON COULD NOT BE ADVANCED. THE MEDICAL TEAM DECIDED TO USE ANOTHER SHEATH AND WHILE REMOVING THE CT SHEATH, THE PHYSICIAN NOTICED THE FUNNEL WAS NO LONGER CONNECTED TO THE DISTAL END OF THE CT SHEATH. FLUOROSCOPY IMAGING REVEALED THAT THE FUNNEL R

  Patient problems: Foreign Body In Patient

  MAUDE report 22377471 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  ON (B)(6) 2025 A 51-YEAR-OLD FEMALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 365 DAYS. AFTER MULTIPLE PASSES, THE FUNNEL OF THE CLOTTRIEVER SHEATH, 13 FR (CT SHEATH) SEPARATED FROM THE SHEATH SHAFT. THE FUNNEL WAS ABLE TO BE REMOVED WITH HEMOSTATS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755212 ↗
• InjuryFeb 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AN INDIVIDUAL UNDERWENT A THROMBECTOMY USING THE INARI CLOTTRIEVER (CT) SYSTEM TO TREAT THEIR RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS. AFTER WIRE POSITIONING WAS ACCOMPLISHED USING A 260CM GLIDE ADVANTAGE WIRE, A 13 FR. CT SHEATH WAS OPENED AND PREPPED. AN 8 FR. SHEATH WAS REMOVED AND THE INARI PREPACKAGED PRE-DILATOR WAS UTILIZED TO DILATE THE ACCESS SITE. THE DILATOR WAS REMOVED AND THE 13FR. SHEATH WAS INSERTED. THE CT SHEATH WAS DEPLOYED IN NORMAL ORDER AND THE MOUNTED DILATOR WAS REMOVED. THE CT CATHETER WAS PREPPED AND THEN INSERTED. 2 PASSES WERE MADE WHICH YIELDED CLOT. AT THIS POINT, THE GLIDE ADVANTAGE WIRE WAS NOTED TO HAVE MOVED BACKWARDS AND SO THE PHYSICIAN ELECTED TO RE-POSITION. IMAGING WAS PERFORMED WHEN A SMALL "CONE SHAPED" RADIOPAQUE OBJECT WAS SEEN. BASED ON ITS SIZE, IT WAS CONCLUDED THAT IT WAS NOT THE TIP OF THE CT CATHETER. INSPECTION BEGAN ON ALL PRODUCTS THAT WERE UTILIZED UP TO THAT POINT. THIS WAS WHEN IT WAS NOTICED THAT THE CT SHEATH'S DILATOR WAS MISSING ITS TIP. THE PHYSICIAN BEGAN TO SLOWLY PULL BACK THE GUIDEWIRE AS THE TIP APPEARED TO BE SLIGHTLY FIXED TO THE END, HOWEVER, THE TIP DISLODGED AND MIGRATED TO A SUB-SEGMENTAL BRANCH IN THE RIGHT P

  Patient problems: Foreign Body In Patient

  MAUDE report 21429013 ↗
• InjuryDec 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON OCTOBER 9, 2023, A SUCCESSFUL DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY WAS PERFORMED USING THE INARI CLOTTRIEVER SYSTEM. ON (B)(6) 2023, THIS PATIENT UNDERWENT FOREIGN BODY REMOVAL; IMAGING REVEALED THAT THE FOREIGN BODY ORIGINATED FROM AN INARI CLOTTRIEVER SHEATH (DISTAL 1 CM OF THE SHEATH AND FUNNEL). THE MATERIAL REMOVED FROM THE PATIENT HAD A CLEAN CUT, LIKELY FROM CONTACT WITH A SCALPEL. THE HOSPITAL IS IN CURRENT POSSESSION OF THE DEVICE FRAGMENT AND IS PERFORMING AN INTERNAL ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411122 ↗
• InjuryDec 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 53-YEAR-OLD FEMALE WITH A HISTORY OF STAGE 4 BREAST CANCER AND ONGOING GASTROINTESTINAL (GI) ILLNESS PRESENTED TO THE EMERGENCY DEPARTMENT WITH EXERTIONAL DYSPNEA. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DURING HER STAY THE PATIENT DEVELOPED RIGHT UPPER EXTREMITY SWELLING UNRESOLVED BY THE LYMPHEDEMA PUMP. A DUPLEX ULTRASOUND WAS PERFORMED WHICH REVEALED DEEP VEIN THROMBOSIS (DVT) IN THE UPPER RIGHT EXTREMITY. A THROMBECTOMY WAS SCHEDULED WITH THE INARI CLOTTRIEVER SYSTEM. DURING THE THROMBECTOMY, THE PATIENT'S RIGHT BRACHIAL VEIN WAS UTILIZED AS THE ACCESS SITE. THE PROCEDURE WAS SUCCESSFUL, AND THE COMPLETE THROMBUS WAS REMOVED. THE POST-PROCEDURE VENOGRAM AND INTRAVASCULAR ULTRASOUND REVEALED RESTORED PATENCY. HOWEVER, UPON REMOVAL OF THE CLOTTRIEVER SHEATH 13 FR, A SMALL SEGMENT OF THE PATIENT'S BRACHIAL VEIN AVULSED OUTSIDE THE ARM. THE PHYSICIAN TIED DOWN THE VEIN AND SURGICALLY SUTURED IT TO CONTROL BLEEDING. MINIMAL BLOOD LOSS WAS NOTED AND NO OTHER COMPLICATIONS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.

  Patient problems: Perforation of Vessels

  MAUDE report 18323429 ↗
• InjuryDec 1, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  A 65-YEAR-OLD MALE PATIENT WITH DEEP VEIN THROMBOSIS (DVT) IN THE UPPER LEFT EXTREMITY UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER BOLD CATHETER. THE CLOT AGE WAS ESTIMATED AT 15 DAYS. THE TREATMENT WAS SUCCESSFUL WITH REMOVAL OF THE ENTIRE CLOT; HOWEVER, WHEN PREPARING FOR CLOSURE, THE PHYSICIAN FELT RESISTANCE AS THE CLOTTRIEVER SHEATH WAS BEING REMOVED FROM THE ACCESS SITE IN THE BASILIC VEIN. THE PHYSICIAN APPLIED EXCESSIVE FORCE TO ENABLE REMOVAL OF THE SHEATH AND UPON REMOVAL, IT WAS NOTICED THAT THE BASILIC VEIN HAD TORN. A VENOGRAM WAS PERFORMED WHICH REVEALED NO HARM TO THE DEEP VENOUS SYSTEM. THE ARM WAS WRAPPED WITH A COMPRESSION BANDAGE AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Vascular Dissection

  MAUDE report 18253159 ↗
• InjurySep 26, 2023Collapse; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Collapse; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  A FEMALE IN HER EARLY 40S WAS DIAGNOSED WITH A LEFT UPPER EXTREMITY DEEP VEIN THROMBOSIS (DVT). THE CLOT AGE WAS APPROXIMATELY 20 DAYS. THE PATIENT WAS SCHEDULED TO UNDERGO A THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM. ACCESS WAS ATTEMPTED AT THE LEFT BASILIC VEIN. THE PHYSICIAN DILATED AND INSERTED THE CLOTTRIEVER 13 FR SHEATH. AT THIS POINT, IT WAS ASSUMED THAT THE DILATOR BECAME CAUGHT ON A VALVE OR NARROW VEIN SEGMENT. AFTER THE FUNNEL WAS DEPLOYED APPROPRIATELY, THE DILATOR BECAME STUCK IN THE VESSEL AND WAS UNABLE TO BE REMOVED. EACH ATTEMPT TO RETRACT THE DILATOR CRUSHED THE FUNNEL. THE SHEATH WAS REMOVED FROM THE PATIENT AND ADDITIONAL DILATION AND BALLOONING OF THE ACCESS SITE WAS PERFORMED TO REMOVE THE DILATOR; HOWEVER, THE BASILIC VEIN TORE DURING DEVICE REMOVAL. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS DISCHARGED THE SAME DAY IN STABLE CONDITION. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN WHO REPORTED THAT THE PATIENT'S VEINS ARE VERY RESILIENT AND THE VEIN WAS EXPECTED TO CLOSE OFF.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 17822244 ↗

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