WOLF Thrombectomy System, 8F FD0427-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850029546245), received between Nov 17, 2022 and Nov 29, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Entrapment of Device; Defective Device; Entrapment of Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS ENTRAPPED ON THE GUIDEWIRE. AN 8FR WOLF THROMBECTOMY CATHETER AND V-14 CONTROL WIRE WERE SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. THE PATIENT PRESENTED WITH AN OCCLUDED POPLITEAL ARTERY. ACCESS WAS ACHIEVED VIA IPSILATERAL APPROACH WITH A NON-BSC SHEATH. THE V-14 CONTROL WIRE WAS ANTEGRADE THROUGH THE POPLITEAL ARTERY. THERE WAS A HIGH ANTERIOR TIBIAL TAKEOFF WHICH STARTED AT THE TIBIAL PLATEAU. THE WOLF CATHETER WAS SUCCESSFULLY ADVANCED TO THE BLOOD CLOT. THE CLOT WAS INGESTED USING THE PIN AND PUSH TECHNIQUE. RESISTANCE WAS OBSERVED WHEN THE WOLF CATHETER WAS MOVED INTO THE DISTAL POPLITEAL. AFTER THE CLOT HAD BEEN CAPTURED, THE WOLF CATHETER WAS ATTEMPTED TO BE REMOVED OVER THE V-14 CONTROL WIRE. THE WOLF CATHETER BECAME ENTRAPPED ON THE WIRE. BOTH THE WOLF CATHETER AND V-14 WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15878389 ↗
• InjuryNov 22, 2022Mechanical Problem; Difficult to Advance; Mechanical Problem; Difficult to Advance

  IT WAS REPORTED THAT AN EMBOLISM OCCURRED. AN 8FR WOLF THROMBECTOMY CATHETER WAS SELECTED FOR USE. THE WOLF CATHETER WAS PLACED INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH AN 8F NON-BSC SHEATH. THE DEVICE WAS ADVANCED 1-2CM INTO THE TARGET VESSEL. THE THROMBUS WAS ENGAGED, AND A SLEEVE PULL WAS PERFORMED WHICH CONSUMED THE ENTIRE THROMBUS. UPON REMOVAL OF THE WOLF CATHETER, ADDITIONAL CLOT WAS OBSERVED IN THE RIGHT PROFUNDA. AN ATTEMPT WAS MADE TO RELOAD A SLEEVE ON THE WOLF CATHETER. DURING THAT PROCESS, THE INNER SHAFT WOULD NOT EXIT THE ATTACHED ROTATING HEMOSTATIC VALVE (RHV). THIS RESULTED IN BUNCHING OF THE SLEEVE AT THE DISTAL END. A NEW WOLF CATHETER WAS SELECTED, BUT IT WAS DIFFICULT TO ADVANCE TO THE SFA. A NON-BSC DEVICE WAS THEN USED TO REMOVE THE REMAINING CLOT. THERE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Embolism/Embolus

  MAUDE report 15846863 ↗
• MalfunctionNov 17, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH LEFT ILIOFEMORAL THROMBOSIS. AN 8FR WOLF THROMBECTOMY CATHETER WAS SELECTED FOR USE. A .014 GUIDEWIRE WAS ADVANCED UP THROUGH THE THROMBUS AND INTO THE AORTA, THE 8F SHEATH WAS POSITIONED TO PERFORM WOLF THROMBECTOMY. THE 8F WOLF THROMBECTOMY SYSTEM WAS ADVANCED THROUGH THE SHEATH WITHOUT ANY ISSUE OUT OF THE END OF THE 8F NON-BSC SHEATH AND 1CM INTO THROMBUS. THE PHYSICIAN CONTROLLED AND HELD WOLF SHAFT WHILE PHYSICIAN INSTRUCTED HIS ASSISTANT TO ADVANCE THE WOLF CATHETER. THE WOLF SYSTEM WAS SUCCESSFULLY OPERATED TO CAPTURE THE THROMBUS. DURING THE FINAL PULL AT THE END OF THE THROMBOSED LESION, THEY NOTICED THE CUFF WAS NO LONGER MOVING UP THE WOLF CATHETER AS IT SHOULD DUE TO A TORN SLEEVE. THE PHYSICIAN WITHDREW THE WOLF SYSTEM AS A WHOLE INTO THE 8F SHEATH AND ONCE THE FUNNEL OF THE WOLF CATHETER REACHED THE VALVE OF THE SHEATH, THE PHYSICIAN HAD EXCESSIVE RESISTANCE. THE PHYSICIAN WRAPPED THE CATHETER AROUND HIS HAND AND THE WOLF CATHETER EXTREMELY HARD. THIS ACTION CAUSED THE FUNNEL OF THE WOLF CATHETER TO SEPARATE FROM THE REST OF THE WOLF CATHETER. THE FUNNEL AND PART OF THE SLEEVE WERE STILL CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811746 ↗