WOLF Thrombectomy System, 14F FD0364-03Recalls & reported problems
Devoro Medical Inc. · WOLF Thrombectomy System, 14F - 8mm Funnel x 110cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850029546030), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (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
Device problems
- Difficult to Advance1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2023Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. A WOLF VENOUS THROMBECTOMY CATHETER WAS SELECTED FOR USE. TO BEGIN THE PROCEDURE, A VENOGRAM WAS PERFORMED AND IVUS WAS UTILIZED TO CONFIRM CLOT WAS ACUTE AND MEASURE VESSEL SIZE FROM IVC DOWN TO PROXIMAL POPLITEAL-DISTAL SFV (10MM VESSEL). THROUGH THE 14FR WOLF SHEATH, THE PHYSICIAN ADVANCED WOLF CATHETER INTO CLOT AND WAS ABLE TO PULL IN CLOT WITH ABOUT 20CM OF THE SLEEVE. UPON 3RD 1CM ADVANCEMENT, THE PHYSICIAN MET A LOT OF RESISTANCE AND NOTED THAT THE CATHETER WOULD BOUNCE BACKWARDS. THE PHYSICIAN STOPPED AND THEN ATTEMPTED TO PULL ON THE SLEEVE, THINKING HE WAS IN CLOT. HE DID THIS AND ALSO APPLIED FORWARD PRESSURE ON THE CATHETER. ONCE HE FULLY ARTICULATED THE SLEEVE, HE REMOVED FOR INSPECTION AND DID A VENOGRAM WHEN A VESSEL PERFORATION WAS NOTED. HE REWIRED, ADVANCED THE SHEATH PAST THE PERFORATION, AND OPTED TO GO DOWN TO A 6MM FUNNELED WOLF CATHETER. HE DID 2 SUCCESSFUL SLEEVE PULLS UP TO THE COMMON FEM VEIN AND THEN DID A FINAL SLEEVE PULL BACK WITH THE 8MM WOLF CATHETER. NEXT, A WOLF THROMBECTOMY SHEATH WAS SELECTED FOR USE. THREE ASPIRATIONS WERE PERFORMED WITH THE WOLF SHEATH. IT WAS OBSERVED A FEW TIMES THAT THE VA
Patient problems: Perforation of Vessels
MAUDE report 17603461 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
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- Indigo System LITNG7XTORQ130-APenumbra, Inc. · Peripheral mechanical thrombectomy with aspiration100 reports
- Indigo System LITNG12XTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death80 reports
- ClotTriever XL Catheter AS-0235Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 recall9 deaths20 reports
- Indigo System LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 reports
- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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