RevCore Thrombectomy Catheter 44-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850291007383), received between Nov 6, 2023 and Dec 18, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A 64-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. UPON REMOVAL OF THE REVCORE CATHETER, IT WAS NOTICED THAT THE RADIOPAQUE TIP HAD SEPARATED FROM THE CATHETER. THE MEDICAL TEAM OBSERVED THE TIP HAD REMAINED ON THE GUIDEWIRE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE TIP BY SNARING THE TIP. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842521 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A 54-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. DURING THE THROMBECTOMY, THE RADIOPAQUE TIP OF THE REVCORE THROMBECTOMY CATHETER (REVCORE) DETACHED FROM THE CATHETER. THE RADIOPAQUE TIP REMAINED ON THE GUIDEWIRE AND WAS ABLE TO BE SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619198 ↗
• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) ,2025, A 46-YEAR-OLD MALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 20 DAYS. DURING THE THROMBECTOMY, WHILE REMOVING THE REVCORE CATHETER FROM THE PATIENT, THE RADIOPAQUE TIP SEPARATED FROM THE CATHETER BUT REMAINED ON THE GUIDEWIRE. THE PHYSICIAN WAS ABLE TO BE ADVANCED AND OUT OF THE PATIENT'S BODY THROUGH THE PROTRIEVE SHEATH THAT WAS IN THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. THE PATIENT DID NOT EXPERIENCE ANY INJURY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND APPROXIMATELY 85% OF THE PATIENT'S CLOT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856326 ↗
• MalfunctionMay 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A 65-YEAR-OLD FEMALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 30 DAYS. DURING THE THROMBECTOMY, WHILE RECAPTURING THE CORING ELEMENT OF THE REVCORE THROMBECTOMY CATHETER (REVCORE), THE OUTER SHEATH CONTINUED FORWARD AND PUSHED THE RADIOPAQUE TIP OFF THE END OF THE DEVICE. THE REVCORE CATHETER WAS REMOVED FROM THE PATIENT WHILE THE RADIOPAQUE TIP REMAINED ON THE GUIDEWIRE. ANOTHER CATHETER WAS OPENED AND ADVANCED OVER THE WIRE. THE CATHETER PUSHED THE RADIOPAQUE TIP INTO THE PROTRIEVE SHEATH. THE RADIOPAQUE TIP WAS EXTERNALIZED FROM THE VALVE OF THE PROTRIEVE SHEATH. THE CASE WAS COMPLETED AND APPROXIMATELY 100% OF THE PATIENT'S CLOT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979608 ↗
• MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A FEMALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 60 DAYS. DURING THE THROMBECTOMY, THE RADIOPAQUE TIP OF THE REVCORE THROMBECTOMY CATHETER (REVCORE) HAD SEPARATED FROM THE CATHETER. A PROTRIEVE SHEATH ASPIRATED THE TIP THROUGH THE PATIENT'S INTERNAL JUGULAR VEIN. THE PROTRIEVE SHEATH WITH THE COLLECTED RADIOPAQUE TIP WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654930 ↗
• MalfunctionFeb 12, 2025Entrapment of Device; Entrapment of Device

  A 71-YEAR-OLD FEMALE WITH THROMBUS IN AN ILIAC STENT UNDERWENT A THROMBECTOMY WITH INARI DEVICES TO TREAT HER DEEP VEIN THROMBOSIS (DVT). THE PATIENT HAD 5 STENTS IN PLACE OVER 14 YEARS. REVCORE WAS USED A YEAR PRIOR WHEN SHE PRESENTED TO THE EMERGENCY DEPARTMENT. THE PLAN WAS TO USE A CLOTTRIEVER SHEATH 16FR TO ACCESS LEFT FEMORAL VEIN, BUT THE SHEATH WOULD NOT ADVANCE INTO THE ACCESS SITE. THE SHEATH WAS PULLED BACK AND OFF THE WIRE. HOWEVER, THE WHITE INTERNAL DILATOR HAD CAUGHT ON THE SHEATH AND WAS NOT SMOOTH, SO A COOK SHEATH 16FR. WAS USED INSTEAD. IMAGING WAS PERFORMED PRIOR TO THE REVCORE BEING ADVANCED OVER THE GUIDEWIRE AND POSITIONED NEAR THE THROMBUS IN THE STENT. THE REVCORE ELEMENT WAS OPENED SLOWLY, AND IMAGING WAS PERFORMED WHILE ROTATING THE CORING ELEMENT. NO RESISTANCE WAS FELT SO THE PHYSICIAN INCREASED THE ELEMENT SIZE SLOWLY UNDER IMAGING. AT THIS POINT, SOME RESISTANCE WAS FELT SO THE PHYSICIAN PULLED THE REVCORE DISTAL WHILE ROTATING CLOCKWISE THEN COUNTERCLOCKWISE. ROTATIONS WERE STOPPED AND IMAGING WAS PERFORMED. THE REVCORE WAS RE-SHEATHED AND REMOVED. RESISTANCE WAS MET UPON REMOVAL FROM THE STENT. IMAGING REVEALED THAT THE REVCORE WAS ENGAGED WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370418 ↗
• MalfunctionDec 11, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ON (B)(6) 2024 AN 82-YEAR-OLD MALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT 28 DAYS. AFTER SEVERAL SUCCESSFUL PASSES COMPLETED USING A REVCORE THROMBECTOMY CATHETER (REVCORE), THE PHYSICIAN COMPLETED ONE MORE PASS TO REMOVE THE LAST REMAINING CLOT. AS THE PHYSICIAN COLLAPSED THE CORING ELEMENT, IT WAS NOTED ON IMAGING THAT THE TIP DID NOT MOVE, AND THE MEDICAL TEAM REALIZED THE TIP HAD SEPARATED FROM THE DEVICE. THE CATHETER WAS REMOVED, AND THE TIP REMAINED IN THE PATIENT'S VESSEL. IMAGING SHOWED 100% OF THE CLOT WAS REMOVED FROM THE PATIENT'S VESSEL. IN THE FOLLOWING DAYS, THE PATIENT UNDERWENT A VENOUS CUTDOWN AND THE REVCORE TIP WAS REMOVED SUCCESSFULLY.

  Patient problems: Foreign Body Embolism

  MAUDE report 20906960 ↗
• MalfunctionDec 10, 2024Entrapment of Device; Entrapment of Device

  ON (B)(6) 2024, A 39-YEAR-OLD MALE PATIENT UNDERWENT A DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD PREEXISTING STENTS PLACED IN THE LEFT COMMON ILIAC AND THE LEFT EXTERNAL ILIAC VEINS. THE CLOT AGE WAS ESTIMATED AT 21 DAYS. DURING THE THROMBECTOMY, THE REVCORE CATHETER BECAME CAUGHT ON ONE OF THE PATIENT'S PREEXISTING STENT STRUTS BUT THE ENTIRE DEVICE WAS ABLE TO BE RESHEATHED AND REMOVED FROM THE PATIENT. BALLOON ANGIOPLASTY AND INTRAVASCULAR ULTRASOUND (IVUS) DID NOT SHOW ANY ISSUES WITH THE PATIENT'S STENT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT WITH APPROXIMATELY 100% CLOT REMOVED. THE PATIENT RETURNED APPROXIMATELY ONE WEEK POST-PROCEDURE AND PRESENTED WITH SWELLING. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED NO INJURY TO THE PATIENT'S VEIN, BUT THE PATIENT HAD RE-THROMBOSED AND A STENT STRUT WAS BROKEN. THE PATIENT WAS THEN TREATED WITH LYRICS AND A SECOND STENT WAS PLACED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20898131 ↗
• MalfunctionOct 17, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  ON (B)(6) 2024, A 56-YEAR-OLD FEMALE UNDERWENT A LOWER LEFT EXTREMITY (LLE) DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD PRE-EXISTING STENTS IN HER LLE AND UNDERWENT A SUCCESSFUL LLE DVT SIX MONTHS PRIOR. UPON A FOLLOW-UP VISIT, IT WAS NOTED THAT THE SAME REGION HAD THROMBOSED. OVER THE FIRST THREE HOURS OF THE THROMBECTOMY, MULTIPLE ATTEMPTS TO CROSS THE LESION WERE MADE USING VARIOUS WIRE AND CATHETER COMBINATIONS, AS WELL AS VENOPLASTY. THE WIRE WAS EVENTUALLY EXTERNALIZED SUCCESSFULLY. REVCORE WAS THEN INTRODUCED, AND THE CORING ELEMENT WAS EXPANDED, WITHOUT THE USE OF INTRAVASCULAR ULTRASOUND (IVUS). THE DEVICE BECAME STUCK IN AN AREA WHERE THE PATIENT'S STENTS OVERLAPPED. THE CATHETER WAS PULLED FORCEFULLY TO FREE THE DEVICE. THE ENTIRE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT INJURY, EXCLUDING THE NOSE CONE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE NOSE CONE; HOWEVER, THEY WERE UNSUCCESSFUL. THE NOSE CONE REMAINS IN THE PATIENT'S VESSEL, EMBEDDED IN THE PATIENT'S STENT/CLOT AND IS UNLIKELY TO MOBILIZE. THE CASE ENDED WITH NO ADDITIONAL ISSUES. A FINAL VENOGRAM REVEALED THERE WERE NO FLOW ISSUES, AND THE COLLATERALS REMAINED INTA

  Patient problems: Foreign Body In Patient

  MAUDE report 20474948 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT WITH DEEP VEIN THROMBOSIS (DVT) AND PREEXISTING VENOUS STENTS UNDERWENT THROMBECTOMY WITH INARI DEVICES ON (B)(6) 2024. THE CLOT AGE WAS ESTIMATED AT 180 DAYS. DURING THROMBECTOMY, FLOWTRIEVER CATHETER, XL DISKS WERE PLACED ABOVE THE PATIENT'S INFERIOR VENA CAVA (IVC) FILTER AND INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO OBTAIN MEASUREMENTS. AFTER ACCESS WAS OBTAINED, A REVCORE THROMBECTOMY CATHETER (REVCORE) WAS ADVANCED INTO THE LEFT POPLITEAL VEIN. THE REVCORE WAS USED AT THE PROXIMAL EDGES OF THE STENT AND MOVED DISTALLY, USING THE SCRUBBING TECHNIQUE. NO CLOT WAS REMOVED AFTER THREE PASSES. ON THE FOURTH PASS, THE PHYSICIAN MOVED THE DEVICE INFERIOR TO SUPERIOR, TOWARDS THE CONFLUENCE, AND THE MEDICAL TEAM NOTICED THE RADIOPAQUE TIP WAS SEPARATED FROM THE CATHETER AND REMAINING ON THE GUIDEWIRE, INFERIOR TO THE STENT. THE MEDICAL TEAM ATTEMPTED TO SNARE AND ASPIRATE THE TIP; HOWEVER, THE TIP WAS IRRETRIEVABLE. THE RADIOPAQUE TIP REMAINS IN THE PATIENT, AND A COOK COVERED STENT WAS PLACED ON TOP OF THE TIP. THE CASE WAS CONCLUDED. THERE WAS NO RESULTING PATIENT INJURY OR DAMAGE TO THE PREEXISTING STENTS. POSTOPERATIVELY, THE PATIENT IS DOING WELL IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19262242 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A 50-YEAR-OLD MALE PATIENT WITH A LOWER-LEFT EXTREMITY (LLE) DEEP VEIN THROMBOSIS (DVT) AND PREEXISTING VENOUS STENT UNDERWENT THROMBECTOMY WITH INARI DEVICES ON (B)(6), 2024. THE CLOT AGE WAS ESTIMATED AT 21 DAYS. DURING THROMBECTOMY, THE PATIENT WAS POSITIONED SUPINE AND THE CLOTTRIEVER SHEATH, 13FR (CT SHEATH) WAS INSERTED INTO THE LEFT POPLITEAL VEIN AND THE PROTRIEVE SHEATH (PT SHEATH) WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN. THE REVCORE CATHETER WAS ADVANCED THROUGH THE CT SHEATH IN THE POPLITEAL VEIN AND COMPLETED TWO SUCCESSFUL PASSES CENTRAL TO PERIPHERAL, WITH THE CORING ELEMENT OPENED LESS THAN HALF FULL SIZE. WHILE REPOSITIONING FOR A THIRD PASS, THE MEDICAL TEAM NOTICED THE REVCORE CATHETER RADIOPAQUE TIP AND CORING ELEMENT HAD SEPARATED AS THE RADIOPAQUE TIP WAS OBSERVED AT THE CENTRAL END OF THE IMPLANTED STENT AND THE CORING ELEMENT WAS OBSERVED AT THE PERIPHERAL END OF THE STENT. THE PHYSICIAN THEN ADVANCED THE GUIDEWIRE THROUGH AND EXTERNAL TO THE PT SHEATH UNTIL THE RADIOPAQUE TIP WAS SAFELY REMOVED FROM THE PATIENT. THE REMAINDER OF THE REVCORE CATHETER WAS SAFELY REMOVED THOUGH THE ORIGINAL POINT OF ACCESS, VIA THE CT SHEATH IN THE LEFT POPLITEAL VEIN. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169611 ↗
• InjuryNov 6, 2023Material Separation; Detachment of Device or Device Component; Device Damaged by Another Device; Migration; Material Separation; Detachment of Device or Device Component; Device Damaged by Another Device; Migration

  PATIENT FOLLOW UP WITH THE PHYSICIAN WAS OBTAINED SHORTLY AFTER THE PROCEDURE AND AGAIN SEVERAL WEEKS LATER. THE PHYSICIAN CONFIRMED THE PATIENT WAS DOING WELL AND THERE HAS BEEN NO SEQUELAE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18080825 ↗