Gunther Tulip G03766Recalls & reported problems
William Cook Europe ApS · Gunther Tulip, Vena Cava Filter, Femoral Approach · Class 2 · Implant
All models of Gunther Tulip (4)
Data updated Oct 18, 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 10827002037660), received between May 16, 2017 and May 16, 2017 — 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 18, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Kinked1
- Material Perforation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2017Kinked; Material Perforation; Difficult to Advance; Kinked; Material Perforation; Difficult to Advance
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: " FEMORAL TULIP PLACEMENT, THE FIRST FILTER WENT RIGHT THROUGH THE SIDE OF THE DELIVERY SHEATH. THEY PLACED ANOTHER TULIP SUCCESSFULLY." ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN: "ACCESSING LEFT FEMORAL VEIN, ONCE DILATOR WAS OUT, THEY SAW IT WAS A BIT KINKED. HE THOUGHT WITH THIS MALE IN HIS 80¿S WITH A PENILE IMPLANT THAT THE PART SUPPLYING BLOOD TO THE IMPLANT COULD HAVE BEEN PRESSING ON THE VEIN OR THAT THE VEIN MAY HAVE BEEN TORTUOUS CAUSING SOME KINKING. THEY WERE NOT OVERLY CONCERNED AS THIS HAS HAPPENED WITH THE CLASSIC SYSTEM ONCE BEFORE AND THEY DID NOT HAVE ANY TROUBLE PLACING THE FILTER (B)(4). THIS TIME, WHEN ADVANCING THEY MET RESISTANCE (B)(4). THEY LOOKED ON FLURO AND THERE WAS A SLIGHT KINK AND THE HOOK WAS PROTRUDING OUT OF THE VEIN. THIS WAS HIS FIRST TIME USING FEMORAL APPROACH WITH NAVALIGN (HE HAS HAD THE JUGULAR NAVALIGN FOR OVER A YEAR AND HAS ONLY RECENTLY BEEN USING THE FEMORAL NAVALIGN AND THEY THOUGHT PERHAPS THE SHEATH TOLERATED THE TORTUOSITY OF THE FEMORAL VEIN A BIT LESS THAN THE OLD CLASSIC SYSTEM, WHICH IS POSSIBLE AS THE SHEATH IS A SMALLER FRENCH SIZE. THEY WERE ABLE TO REMOVE THE SHEATH WIT
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6568445 ↗
Other FILTER, INTRAVASCULAR, CARDIOVASCULAR devices
- Denali® Vena Cava Filter DL900FBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR22 deaths529 reports
- DENALI® Vena Cava Filter DL900JBard Peripheral Vascular, Inc. · FILTER, INTRAVASCULAR, CARDIOVASCULAR15 deaths492 reports
- Option Elite Retrievable Vena Cava Filter System 352506070EArgon Medical Devices, Inc. · Filter, Intravascular, Cardiovascular2 recalls3 deaths342 reports
- Gunther Tulip G33016Cook Incorporated · FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths348 reports
- Gunther Tulip G33017Cook Incorporated · FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths286 reports
- Cook Celect G34309William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death230 reports
- Gunther Tulip G52916William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths189 reports
- Cook Celect G34502William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths165 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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