WOLF Thrombectomy System, 7F FD0427-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850029546238), received between Mar 8, 2023 and Jun 9, 2023 — 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 18, 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.

• MalfunctionJun 9, 2023Material Deformation; Material Deformation

  REPORTABLE UPON ANALYSIS COMPLETED ON 22MAY2023. IT WAS REPORTED THAT THE CATHETER HAD KINKED. A 7FR WOLF ARTERIAL THROMBECTOMY CATHETER WAS SELECTED FOR USE. LEFT FEMORAL ACCESS WAS OBTAINED AND A GUIDE SHEATH WAS INSERTED OVER THE BIFURCATION INTO THE RIGHT COMMON FEMORAL ARTERY. A 7FR WOLF ARTERIAL THROMBECTOMY CATHETER WAS ADVANCED. UPON INGESTING THE CLOT USING A PIN AND PULL METHOD, RESISTANCE WAS OBSERVED. AFTER THE SLEEVE HAD CAPTURED THE CLOT, THE INNER CATHETER WAS ATTEMPTED TO BE REMOVED. HOWEVER, DURING REMOVAL THE SHAFT SNAPPED IN HALF. THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED. A SECOND DEVICE, SAME MODEL, WAS SELECTED FOR USE. THE REMAINING CLOT WAS SUCCESSFULLY REMOVED USING THIS CATHETER. UPON REMOVAL, IT WAS OBSERVED THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURE AT THE KINKED AREA ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099415 ↗
• MalfunctionApr 19, 2023Mechanical Problem; Defective Device; Detachment of Device or Device Component; Mechanical Problem; Defective Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHAFT DETACHED. LEFT FEMORAL ACCESS WAS OBTAINED USING A NON-BSC 7FR SHEATH THAT WENT UP AND OVER THE BIFURCATION, AND WAS PARKED IN THE RIGHT COMMON FEMORAL ARTERY. AFTER CROSSING FROM ABOVE AND BELOW, DR. HAD A NON-BSC 300CM .014 GUIDEWIRE THAT EXTENDED FROM THE NON-BSC SHEATH, THROUGH THE SUPERFICIAL FEMORAL ARTERY (SFA) LESION, DOWN THE ANTERIOR TIBIAL ARTERY AND EXITING A SMALL SHEATH IN THE PATIENTS RIGHT FOOT, WHERE A HEMOSTAT WAS CLAMPED ON THE WIRE TO ENSURE WIRE ACCESS WOULD NOT BE LOST. A 7FR WOLF ARTERIAL THROMBECTOMY CATHETER WAS ADVANCED TO THE TARGET LOCATION. WHILE PINNING AND PULLING THE DEVICE TO CAPTURE THE CLOT, RESISTANCE WAS NOTED. WHILE FINISHING THE SLEEVE PULL, AND REMOVAL OF THE INNER CATHETER, THE SHAFT SNAPPED IN HALF. THE CATHETER WAS THEN REMOVED FROM THE PATIENT. A NEW DEVICE, SAME MODEL, WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16772559 ↗
• InjuryMar 8, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THERE WAS LOSS OF BLOOD FLOW TO THE FOOT. THE WOLF THROMBECTOMY SYSTEM WAS SELECTED TREATMENT OF THROMBOSIS OF LEFT LOWER EXTREMITY FEMORAL PERONEAL SYNTHETIC BYPASS GRAFT (PLACED IN 2019). THE WOLF WAS CHOSEN AFTER THE PATIENT PULLED OUT THE EKOS CATHETER PREMATURELY OVERNIGHT, FOLLOWED BY ASPIRATION THROMBECTOMY WITH A NON-BSC DEVICE AND SUBSEQUENT PLACEMENT OF A STANDARD THROMBOLYSIS CATHETER. THE PATIENT WAS BROUGHT BACK TO THE LAB AND ONCE THROMBOLYSIS CATHETER WAS REMOVED, PHYSICIAN CONFIRMED PATIENT HAD BLOOD FLOW IN THE PERONEAL AND INTO THE FOOT, HOWEVER, HAD A 25CM OCCLUSION IN THE PROXIMAL PORTION OF THE BYPASS GRAFT. DURING WOLF PLACEMENT, THE PHYSICIAN HAD COMPLETED THE FIRST SLEEVE PULL AND CONFIRMED WIRE MOVEMENT THROUGH THE INNER SHAFT. WHILE REMOVING, THE CATHETER AND INNER SHAFT/SLEEVE BECAME TIGHT AND UNABLE TO REMOVE WITHOUT LOSING WIRE. THE REMOVAL WAS STOPPED, AND THE CATHETER WAS PUSHED FURTHER DISTAL AND THEN REMOVING THE INNER SHAFT WITH THE NON-BSC WIRE TO RELOAD AND TRY AGAIN. ONLY MINIMAL CLOT WAS ABLE TO BE REMOVED, SO PHYSICIAN OPTED TO RUN TWO OTHER NON-BSC DEVICES WITH MINIMAL CLOT REMOVED. AS A RESULT, IT APPEARED THAT CLOT WAS

  Patient problems: Embolism/Embolus

  MAUDE report 16503919 ↗