WOLF Thrombectomy System, 14F FD0364-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850029546054), received between Aug 29, 2023 and Nov 27, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2023Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  REPORTABLE ON ANALYSIS COMPLETED ON 30OCT2023. IT WAS REPORTED THAT THE CATHETER FUNNEL WAS DIFFICULT TO EXPAND. A 12MM WOLF VENOUS CATHETER WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. THE 12MM WOLF CATHETER WAS PREPPED AND DELIVERED THROUGH THE WOLF SHEATH. IT WAS OBSERVED THE WOLF FUNNEL COULD NOT FULLY DEPLOY DUE TO OVERSIZING. IT WAS AT THIS POINT THEY REALIZED THEY SHOULD HAVE CHOSEN AN 8MM FUNNEL. DURING REMOVAL OF THE WOLF CATHETER, THERE WAS FORCE CREATED FROM THE OVERSIZING AND COMPRESSED THE END OF THE WOLF SHEATH. THE WOLF CATHETER AND SHEATH WERE SUCCESSFULLY REMOVED WITH NO HARM TO THE PATIENT. A NEW WOLF SHEATH WAS INSERTED SUCCESSFULLY, AND AN 8MM FUNNEL WOLF CATHETER WAS UTILIZED IN THE SAME ANATOMY SUCCESSFULLY WITHOUT ANY ISSUES. AS THE THROMBECTOMY PROGRESSED INTO A LARGER VENOUS ANATOMY (PROXIMAL FEMORAL ARTERY) IT WAS OBSERVED A LARGER FUNNEL WOLF CATHETER MAY BE BENEFICIAL TO USE IN THIS PROXIMAL ANATOMY. A SECOND 12MM FUNNEL WOLF CATHETER WAS DECIDED TO BE PREPPED AND USED IN THE PROXIMAL FEMORAL AND COMMON FEMORAL. THE SECOND 12MM FUNNEL WOLF CATHETER WAS PREPPED AND ADVANCED THROUGH THE WOLF SHEATH SUCCESSFULLY. WHILE DEPLOYING THE 12MM FUNNEL ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210860 ↗
• MalfunctionAug 29, 2023Defective Device; Detachment of Device or Device Component; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SLEEVE DETACHED. A 12MM WOLF VENOUS THROMBECTOMY CATHETER WAS SELECTED FOR USE IS THE DISTAL FEMORAL VEIN. THE 12MM WOLF VENOUS CATHETER WAS SUCCESSFULLY ADVANCED THROUGH THE WOLF SHEATH. HOWEVER, THE FUNNEL ON THE WOLF VENOUS CATHETER COULD NOT DEPLOY AS IT WAS TOO LARGE. THE WOLF VENOUS CATHETER AND SHEATH WERE SUCCESSFULLY REMOVED AND EXCHANGED FOR NEW DEVICES. AN 8MM WOLF VENOUS THROMBECTOMY CATHETER WAS ADVANCED TO THE TARGET LESION AND SUCCESSFULLY USED. AS THE THROMBECTOMY PROCEDURE PROGRESSED INTO LARGER VENOUS ANATOMY (PROXIMAL FEMORAL ARTERY), IT WAS DETERMINED A LARGER WOLF VENOUS CATHETER WAS REQUIRED. A 12MM WOLF VENOUS CATHETER WAS THEN ADVANCED TO THE PROXIMAL FEMORAL VEIN, HOWEVER, IT WAS OBSERVED THAT THE CATHETER WAS TOO LARGE AS WELL. DURING REMOVAL OF THE WOLF VENOUS CATHETER INTO THE WOLF SHEATH, THE 12MM FUNNEL SLEEVE DETACHED. THE 12MM FUNNEL WOLF CATHETER, SLEEVE AND WOLF SHEATH WERE ALL ABLE TO BE REMOVED FROM THE PATIENT EASILY WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646310 ↗