ClotTriever BOLD CatheterRecalls & reported problems across all models

We found 2 models of ClotTriever BOLD Catheter by Inari Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2022 and Aug 25, 2026 — classified as 9 deaths, 13 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 BOLD Catheter problems

ClotTriever BOLD Catheter models

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

• ClotTriever BOLD Catheter 42-102

  Catheter, Continuous Flush
  6 deaths19 reports
• ClotTriever BOLD Catheter 42-102

  Peripheral Mechanical Thrombectomy With Aspiration
  3 deaths8 reports

Recent ClotTriever BOLD Catheter adverse event reports

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

• InjuryAug 25, 2026Entrapment of Device

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50442047 ↗
• MalfunctionMay 19, 2026Retraction Problem

  PRESENTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THROMBECTOMY FOR A LONG DVT. DURING THE USE OF THE STRYKER PERPHERAL VASCULAR CLOTTRIEVER, THE OCCLUSIVE NATURE OF THE DVT MADE THE USE OF THE INARI CLOTTRIEVER UNSUCCESSFUL BECAUSE IT COULD NOT PERFORM A SHEATH WITHDRAWAL. AS SUCH, AN OPEN POPLITEAL VEIN CUTDOWN FOR EXTRACTION OF DEVICE WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221564 ↗
• DeathFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026 A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT WAS INTUBATED AND POSITIONED PRONE FOR THE PROCEDURE. THE PATIENT'S LEFT POPLITEAL VEIN WAS ACCESSED AND INITIAL VENOGRAM SHOWED CLOT EXTENDING FROM THE PATIENT'S FEMORAL VEIN TO THEIR COMMON ILIAC VEIN. THE CLOTTRIEVER BOLD CATHETER (CT BOLD) WAS DEPLOYED INTO THE PATIENT'S INFERIOR VENA CAVA (IVC). WHILE CLEANING THE CT BOLD AFTER A PASS, IT WAS NOTED THAT THE PATIENT'S END-TIDAL CARBON DIOXIDE (ETCO2) DECREASED AND THE PATIENT HAD ECTOPIC HEARTBEATS. THE PHYSICIAN ENSURED THE GUIDEWIRE WAS NOT IN THE HEART VIA FLUOROSCOPY. HOWEVER THE PATIENT CONTINUED TO DETERIORATE. THE PHYSICIAN THEN TOOK IMAGES OF THE PATIENT'S PROXIMAL COMMON ILIAC AND IVC AND NO CLOT WAS OBSERVED IN THE IMAGE AND CONTRACT IN THE IVC WAS NOT CLEARING. THE PATIENT WAS THEN FLIPPED SUPINE AND RESUSCITATION EFFORTS BEGAN. CPR WITH DEFIBRILLATION WAS ADMINISTERED AS WELL AS INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA); HOWEVER, DESPITE RESUSCITATION EFFORTS THE PATIENT EXPIRED.

  Patient problems: Pulmonary Embolism

  MAUDE report 24394499 ↗
• InjuryFeb 11, 2026Entrapment of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PRE-EXISTING STENT AND IVC FILTER WITH CLOT LOCATED INSIDE THE STENT. THE PHYSICIAN MADE THE DECISION TO USE THE CLOTTRIEVER BOLD DEVICE TO REMOVE CLOT FROM THE STENT. AFTER DEPLOYMENT, THE BASKET GOT CAUGHT ON THE IVC FILTER. THE CLOTTRIEVER AND IVC FILTER WERE THEN ENTIRELY REMOVED FROM THE PATIENT SIMULTANEOUSLY. THE PATIENT DID NOT SUSTAIN ANY INJURY AND REMAINED IN HOSPITAL FOR FURTHER OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318694 ↗
• DeathDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 73-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) THROMBECTOMY USING INARI DEVICE. THE PATIENT HAD ACTIVE METASTATIC CANCER AND PE WITH CONCOMITANT LEFT DVT IN HIS ILIOFEMORAL VEIN. PRE-PROCEDURE, THE PATIENT WAS RECEIVING SUPPLEMENTAL OXYGEN VIA A VENTURI MASK AT 4 L/MIN. THE PATIENT'S PE WAS TREATED FIRST. ACCESS WAS GAINED IN THE RIGHT COMMON FEMORAL VEIN AND NEARLY ALL OF THE PATIENT'S THROMBUS WAS REMOVED USING THE TRIEVER24 (T24) AND TRIEVER20 CURVE (T20C). THE MEDICAL TEAM THEN TREATED THE PATIENT'S DVT. THE PATIENT WAS MOVED TO FROG LEG POSITION AND ACCESS WAS GAINED IN THE LEFT POPLITEAL VEIN. AFTER COMPLETING SEVERAL VENOGRAMS OF THE LOWER LEFT EXTREMITY, A GUIDEWIRE WAS ADVANCED TO THE PATIENT'S SUPERIOR VENA CAVA (SVC) AND A CLOTTRIEVER SHEATH, 13FR (CT SHEATH) WAS INTRODUCED. FOUR PASSES WERE COMPLETED USING THE CLOTTREIVER BOLD CATHETER, FOLLOWED BY TWO ASPIRATIONS OF THE CT SHEATH. A VENOGRAM WAS PERFORMED WHICH REVEALED NEARLY ALL OF THE THROMBUS WAS REMOVED WITH MINIMAL CLOT REMAINING AND A COMPRESSED AREA IN THE PATIENT'S ILIAC VEIN. THE PATIENT THEN SUFFERED FROM AN ARRHYTHMIA WITH NO IMMEDIATE HEMODYNAMIC

  Patient problems: Pulmonary Embolism

  MAUDE report 23874023 ↗
• InjuryDec 4, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD PREEXISTING CANCER AND A HISTORY OF DVT. THE PATIENT WAS DIAGNOSED WITH A SUBMASSIVE PULMONARY EMBOLISM (PE) PRIOR TO COMING IN FOR THE DVT THROMBECTOMY. THE PATIENT'S DVT EXTENDED FROM THEIR RIGHT TIBIAL VEIN TO THEIR COMMON ILIAC VEINS. ACCESS WAS GAINED ON THE RIGHT SIDE USING THE CLOTTRIEVER SHEATH, 13FR (CT SHEATH) AND CLOTTREIVER BOLD (CT BOLD) USING ULTRASOUND GUIDANCE AND VENOGRAM. IMAGINING REVEALED THE PATIENT HAD EXTENSIVE COLLATERAL VEINS AND CHRONICALLY SCARRED VESSELS. GUIDEWIRE ADVANCEMENT TO THE PATIENT'S INTERNAL JUGULAR (IJ) WAS PROLONGED, BUT THE WIRE WAS ULTIMATELY POSITIONED SUCCESSFULLY. FOUR TREATMENT PASSES WERE COMPLETED, ADDRESSING EACH QUADRANT OF THE VESSEL STARTING AT THE COMMON ILIAC. EACH PASS RETRIEVED A SUBSTANTIAL AMOUNT OF CHRONIC CLOT. ON THE FIFTH PASS, RESISTANCE WAS ENCOUNTERED AS THE BASKET BECAME STUCK WITHIN THE CT SHEATH WHILE RETRACTING THE CORING ELEMENT. IT WAS SUSPECTED THAT THE CT BOLD MAY HAVE CAUGHT ON THE CT SHEATH FUNNEL, POSSIBLY DUE TO THE CT BOLD DEVICE BEING RETRACTED TOO FAR INTO THE CT SHEATH WHILE RETRACTING THE

  Patient problems: Foreign Body In Patient

  MAUDE report 23720408 ↗
• InjuryNov 25, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, A 39-YEAR-OLD FEMALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. DURING THE THROMBECTOMY, THE CLOTTRIEVER BOLD CATHETER (CT BOLD) WAS REMOVED THROUGH THE SHEATH WITHOUT COLLAPSING THE CORING ELEMENT. UPON THE NEXT PASS, RESISTANCE WAS FELT WHEN OPENING THE CORING ELEMENT. THE CORING ELEMENT WAS COLLAPSED TO REMOVE THE DEVICE ON THE SECOND PASS, HOWEVER, IT APPEARED THAT PART OF THE PATIENT'S VEIN WAS ON THE CT BOLD COLLECTION BAG, THOUGH NO EXTRAVASATION WAS NOTED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES.

  Patient problems: Vascular Dissection

  MAUDE report 23651956 ↗
• DeathNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 36-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A HISTORY OF PULMONARY EMBOLISM (PE) AND HAD A PREEXISTING FILTER IN HIS INFERIOR VENA CAVA (IVC). THE PATIENT UNDERWENT A PE THROMBECTOMY IN (B)(6) 2025. THE PATIENT HAD BEEN INCARCERATED THE MONTH BEFORE THE DVT THROMBECTOMY, WHICH LEAD TO THE PATIENT DISCONTINUING HIS ELIQUIS PRESCRIPTION. THE PATIENT SUBSEQUENTLY DEVELOPED CLOT IN HIS IVC FILTER THAT EXTENDED TO HIS BILATERAL VEINS BELOW. THE PATIENT IVC FILTER WAS REMOVED VIA THE INTERNAL JUGULAR VEIN (IJ) AND WAS THEN POSITIONED SUPINE FOR THE REMAINING DVT THROMBECTOMY. FOUR PASSES WERE COMPLETED ON THE LEFT AND SIX ON THE RIGHT USING THE CLOTTRIEVER BOLD CATHETER (CT BOLD). AT THE COMPLETION OF THE PROCEDURE, WHILE THE ACCESS SITE WAS BEING CLOSED, THE PATIENT BEGAN TO DECOMPENSATE. A CODE WAS CALLED, AND THE CRITICAL RESPONSE TEAM ATTEMPTED TO RESUSCITATE THE PATIENT FOR EIGHTY MINUTES; HOWEVER, THE PATIENT ULTIMATELY EXPIRED.

  Patient problems: Pulmonary Embolism

  MAUDE report 23609440 ↗
• DeathSep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CANCER PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ILIOFEMORAL AND INFERIOR VENA CAVA THROMBUS. THE DECISION WAS MADE TO USE THE CLOTTRIEVER BOLD CATHETER (CT BOLD) TO CLEAR THE THROMBUS AND RESTORE FLOW. THE PATIENT ALSO HAD A PRE-EXISTING PULMONARY EMBOLISM THAT DID NOT HAVE A PLAN FOR TREATMENT. THE FIRST PASS WITH THE CT BOLD YIELDED "WHITE JELLY TYPE" CLOT. THE SECOND PASS YIELDED THE SAME THING. AT THIS TIME, THE PATIENT DETERIORATED AND EXPERIENCED A LOSS IN BLOOD PRESSURE AND O2 SATURATION. IT WAS PRESUMED THAT CLOT MAY HAVE EMBOLIZED INTO THE LUNGS. A CODE WAS CALLED, AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. A FAINT PULSE WAS OBTAINED. EXTRACORPOREAL MEMBRANE OXYGENATION WAS BROUGHT IN, BUT THE PATIENT WAS LISTED AS "DO NOT RESUSCITATE". THE PATIENT EXPIRED ON THE TABLE.

  Patient problems: Pulmonary Embolism

  MAUDE report 23009680 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 84-YEAR-OLD FEMALE UNDERWENT A THROMBECTOMY USING THE INARI CLOTTRIEVER BOLD SYSTEM TO ADDRESS HER UPPER EXTREMITY DEEP VEIN THROMBOSIS. AFTER WIRE POSITIONING WAS OBTAINED, THE 13 FR CLOTTRIEVER SHEATH WAS PLACED AND THE CLOTTRIEVER BOLD CATHETER WAS ADVANCED INTO PLACE. A PASS WAS PERFORMED WHICH REMOVED CHRONIC CLOT. AN ANGIOGRAM WAS PERFORMED AND EXTRAVASATION WAS DISCOVERED NEAR THE FUNNEL. AN ANGIOPLASTY WAS PERFORMED BY BALLOONING. AFTER 20 MINUTES, THE PHYSICIAN WAS SATISFIED THAT THE VESSEL DID NOT NEED FURTHER TREATMENT OR STENTING. THE PHYSICIAN ALSO IDENTIFIED A PSEUDO ANEURYSM; HOWEVER, NO ADDITIONAL TREATMENT WAS NECESSARY. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Vascular Dissection

  MAUDE report 22056636 ↗
• DeathMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD FEMALE UNDERWENT A THROMBECTOMY WITH INARI DEVICES TO ADDRESS HER DEEP VEIN THROMBOSIS. THE PATIENT HAD CLOT RANGING FROM THE FEMORAL VEIN INTO THE INFERIOR VENA CAVA (IVC). THE PLAN WAS TO PERFORM THE PROCEDURE WITHOUT EMBOLIC PROTECTION. WIRE POSITIONING WAS OBTAINED WITHOUT ISSUE AND A CLOTTRIEVER BOLD CATHETER WAS ADVANCED INTO PLACE AFTER A 13 FR CLOTTRIEVER SHEATH WAS INSERTED. 3 PASSES WERE PERFORMED THEN THE VITALS MACHINE STOPPED PICKING UP THE PATIENT'S OXYGEN SATURATION. THE PATIENT THEN BECAME TACHYCARDIC AND BEGAN HAVING PREMATURE VENTRICULAR CONTRACTIONS. THE PROCEDURE WAS ABORTED IN ATTEMPTS TO STABILIZE THE PATIENT. A RAPID RESPONSE WAS INITIATED, AND A CODE WAS CALLED SOON AFTER. CARDIOPULMONARY RESUSCITATION WAS CONDUCTED FOR 45 MINUTES BEFORE THE PATIENT'S FAMILY DECIDED TO DISCONTINUE IT. THE PATIENT EXPIRED. FOLLOW-UP INFORMATION REVEALED THAT THE PATIENT'S INITIAL COMPUTED TOMOGRAPHY SCAN SHOWED A SMALL DISTAL PULMONARY EMBOLISM, THE PHYSICIAN DECIDED NOT TO INTERVENE. THE PHYSICIAN ALSO INDICATED THAT THE PATIENT'S DETERIORATION COULD POTENTIALLY BE THE RESULT OF SEDATION AND/OR CLOT BEING SENT TO THE PULMONARY ARTERIES.

  Patient problems: Pulmonary Embolism

  MAUDE report 22037973 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 43-YEAR-OLD OBESE FEMALE WAS DIAGNOSED WITH LOWER LEFT EXTREMITY DEEP VEIN THROMBOSIS (DVT). A THROMBECTOMY WAS SCHEDULED WITH THE INARI CLOTTRIEVER SYSTEM. THE PATIENT WAS PLACED PRONE FOR THE PROCEDURE AND ACCESS WAS OBTAINED. 5K OF HEPARIN WAS ALSO ADMINISTERED. THE PHYSICIAN ALTERNATED PERFORMING PASSES WITH THE CLOTTRIEVER XL CATHETER (CTXL) AND THE CLOTTRIEVER BOLD CATHETER (CT BOLD). THIS REMOVED A SIGNIFICANT AMOUNT OF CHRONIC CLOT. IMAGING WAS PERFORMED THROUGH THE SHEATH WHICH REVEALED PROCEDURAL CLOT. THE CT BOLD WAS REINSERTED TO REMOVE CLOT, BUT THE CLOT APPEARED TO HAVE BEEN PUSHED FORWARD UPON THE REINSERTION. THE PATIENT BECAME AGITATED AND COMPLAINED OF SHORTNESS OF BREATH. THE PATIENT BECAME UNRESPONSIVE AND WENT INTO PULSELESS ELECTRICAL ACTIVITY. A CODE WAS CALLED, AND RESUSCITATION EFFORTS BEGAN. 45 MINUTES OF CARDIOPULMONARY RESUSCITATION WAS PERFORMED WITH THE ADMINISTRATION OF EPINEPHRINE, SODIUM BICARBONATE, AND LIDOCAINE. THE PATIENT THEN STABILIZED. A COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED LATER WHICH REVEALED A SMALL AMOUNT OF SUB-SEGMENTAL CLOT REMAINED. THE PATIENT WAS LAST REPORTED TO BE ALIVE AND RESPONSIVE.

  Patient problems: Pulmonary Embolism

  MAUDE report 21118747 ↗
• MalfunctionJan 2, 2025Break; Break

  ON DECEMBER 4TH 2024, (B)(6) MEDICAL RECEIVED A COPY OF A MEDSUN REPORT (B)(4) ALLEGING "THE COPPER CORE OF THE THROMBECTOMY CATHETER BROKE OFF AFTER SEVERAL USES OUTSIDE THE PATIENT AS THE CATHETER WAS BEING CLEANED/FLUSHED. THERE WAS NO HARM TO THE PATIENT"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21062512 ↗
• InjuryAug 7, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A 67-YEAR-OLD FEMALE WITH DEEP VEIN THROMBOSIS WAS TAKEN IN BY INTERVENTIONAL RADIOLOGY. INFERIOR VENA CAVA (IVC) THROMBUS WAS OBSERVED ON THE COMPUTED TOMOGRAPHY SCAN. THE PHYSICIAN WAS CONFIDENT THAT CLOT WAS ISOLATED TO THE COMMON ILIAC VEIN WITH POSSIBLE THROMBUS AT THE CONFLUENCE. THE PATIENT WAS INITIALLY PLACED ON ANTICOAGULATION, BUT AFTER A WEEK, THE DECISION WAS MADE TO PERFORM A MECHANICAL THROMBECTOMY. A VENOGRAM WAS PERFORMED CONFIRMING THE CLOT LOCATION, IT ALSO REVEALED A SMALL PULMONARY EMBOLISM. RIGHT VENTRICLE DILATION MAY HAVE BEEN PRESENT, BUT THE CLOT WAS TOO DISTAL TO WARRANT INTERVENTION. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT PERFORMED PRE-PROCEDURE TO FURTHER CONFIRM THE CLOT LOCATION AND EXTENT. THE PHYSICIAN PERFORMED 2 PASSES WITH THE CLOTTRIEVER BOLD CATHETER (CT BOLD). THIS REMOVED SMALL AMOUNTS OF ACUTE CLOT AND THE PHYSICIAN DECIDED TO PERFORM IVUS. FREE-FLOATING THROMBUS WAS BRIEFLY OBSERVED BUT DUE TO ENVIRONMENTAL REASONS, IT WAS DIFFICULT TO REPEAT OR PERFORM SYSTEMATIC IVUS UTILIZATION. 2 MORE PASSES WERE COMPLETE WITH MINIMAL CLOT REMOVED. VENOGRAPHY WAS PERFORMED WHICH REVEALED THAT THEY MAY HAVE MOBILIZED THROMBUS INTO AND THROUGH THE IVC AL

  Patient problems: Pulmonary Embolism

  MAUDE report 19933725 ↗
• MalfunctionJul 24, 2024Entrapment of Device; Retraction Problem; Material Separation; Entrapment of Device; Retraction Problem; Material Separation

  ON (B)(6) 2024, A 36-YEAR-OLD MALE WITH LOWER LEFT EXTREMITY DEEP VEIN THROMBOSIS (DVT) UNDERWENT DVT THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A STENT IN THE LEFT COMMON ILIAC VEIN AND PRESENTED WITH SIGNIFICANT SWELLING IN HIS LEFT LEG. THE CLOT AGE WAS ESTIMATED AT 90 DAYS. DURING DVT THROMBECTOMY, A PROTRIEVE SHEATH WAS PLACED IN THE PATIENT'S RIGHT INTERNAL JUGULAR AND THE CLOTTRIEVER SHEATH, 16 FR (CT SHEATH) WAS PLACED IN THE LEFT POPLITEAL VEIN AS THE PRIMARY ACCESS SITE. THE CLOTTRIEVER BOLD (CT BOLD) COMPLETED THREE PASSES BELOW THE PATIENT'S STENT, WITH THE TIP OF THE CT BOLD BELOW THE PROXIMAL END OF THE STENT. THE REVCORE CATHETER COMPLETED FOUR PASSES WITHIN THE STENT. ONE ADDITIONAL PASS WAS COMPLETED WITH THE CT BOLD AND THE DEVICE WAS WALKED DOWN EASILY UNTIL THE CORING ELEMENT WAS HALFWAY DOWN THE FEMORAL VEIN, AT WHICH POINT THE PHYSICIAN EXPERIENCED SIGNIFICANT RESISTANCE TO RETRACT THE CT BOLD CATHETER. MULTIPLE ATTEMPTS WERE MADE TO PULL THE DEVICE BACK, BUT SIGNIFICANT RESISTANCE CONTINUED TO BE A BARRIER. THE CT BOLD WAS EVENTUALLY ABLE TO BE RETRACTED TO THE FUNNEL OF THE CT SHEATH AFTER THE PHYSICIAN ADVANCED THE GRAY OUTER LUMEN OVER THE CORING EL

  Patient problems: Device Embedded In Tissue or Plaque; Hematoma; Vascular Dissection

  MAUDE report 19822610 ↗

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