ClotTriever BOLD Catheter 42-102 (UDI 00810123710393)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810123710393), received between Sep 9, 2025 and Aug 25, 2026 — classified as 3 deaths, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 8 most recent of 8 reports, 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 ↗
• 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 ↗