Gunther TulipRecalls & reported problems across all models
William Cook Europe ApS · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 368
- Deaths reported
- 7
- Injuries reported
- 188
- Recalls
- 1
We found 4 models of Gunther Tulip by William Cook Europe ApS in the FDA's device registry (GUDID). Together they are named in 368 adverse event reports in the FDA's MAUDE database, received between Jan 28, 2015 and Sep 8, 2025 — classified as 7 deaths, 188 injuries, 170 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (79 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Gunther Tulip recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 14, 2022Class IIITerminated
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Z-0875-2022 · Root cause: Labeling design · names 3 of these models · Recall details · FDA record ↗
Most reported Gunther Tulip problems
Device problems
- Appropriate Device Problem Term/Code Not Available85
- Structural Problem79
- Difficult to Remove46
- Malposition of Device45
- Device Tipped Over43
- Difficult or Delayed Activation34
- Activation Failure29
- Obstruction of Flow26
Patient problems
- Perforation of Vessels85
- No Known Impact Or Consequence To Patient82
- No Clinical Signs, Symptoms or Conditions74
- Insufficient Information48
- No Consequences Or Impact To Patient43
- Internal Organ Perforation38
- Pain28
- Anxiety24
Gunther Tulip models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gunther Tulip G52916FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths189 reports
- Gunther Tulip G52917FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall4 deaths111 reports
- Gunther Tulip G52918FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death67 reports
- Gunther Tulip G03766FILTER, INTRAVASCULAR, CARDIOVASCULAR1 report
Recent Gunther Tulip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathSep 8, 2025Inadequate Filtration Process; Inadequate Filtration Process
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2025, A FILTER WAS PLACED IN THE INFERIOR VENA CAVA (IVC) VIA THE RIGHT JUGULAR VEIN. AFTER FILTER PLACEMENT, THE PATIENT RETURNED TO THE ROOM. SUBSEQUENTLY (TIMING UNKNOWN), CARDIAC ARREST OCCURRED AND THE PATIENT DIED. THE PHYSICIAN DOES NOT KNOW THE CAUSE BECAUSE SHE HAS NOT DONE AN AUTOPSY, BUT SHE THINKS THE BLOOD CLOT MAY HAVE SLIPPED THROUGH THE FILTER AND CAUSED PULMONARY EMBOLISM. ON (B)(6) 2025: AFTER OVARIAN TUMOR REMOVAL, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2025: D-DIMER LEVEL WAS HIGH (12.2), AND AN ULTRASOUND CONFIRMED DEEP VENOUS THROMBOSIS (DVT), BUT PULMONARY EMBOLISM (PE) WAS NOT CONFIRMED. INTRAVENOUS (IV) HEPARIN 3.5CC WAS STARTED. ON (B)(6) 2025: AN IVC FILTER WAS PLACED TO PREVENT DVT DISPERSION. HEPARIN 3CC/6H WAS ADMINISTERED 4 TIMES. ON (B)(6) 2025: THE PATIENT BEGAN TO GET OUT OF BED, AND WAS ABLE TO STAND WITHOUT ANY PROBLEMS, SO WAS TRANSFERRED FROM THE ICU TO THE GENERAL WARD. WHEN THE PATIENT BEGAN STEPPING FOR REHABILITATION PURPOSES, SHE LOST CONSCIOUSNESS AT 15:07. HER PULSE WEAKENED AND SHE WENT INTO CARDIAC ARREST, SO SHE WAS MOVED TO THE CATHETERIZATION
Patient problems: Embolism/Embolus
MAUDE report 22990676 ↗InjuryMay 28, 2025Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: GUNTHER TULIP FILTER REPLACEMENT. THE GUNTHER THAT HAD BEEN PLACED WAS SUCCESSFULLY RETRIEVED, AND THE LEGS OF THE NEWLY PLACED IGTCFS-65-1-JUG-TULIP BECAME TANGLED AND DID NOT DEPLOY. THE GUNTHER THAT HAD BEEN PLACED WAS REMOVED USING THE DEVICE (GTRS) THAT WAS USED TO RETRIEVE IT, AND A DIFFERENT DEVICE WAS PLACED. PATIENT OUTCOME: NO HEALTH HAZARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22094482 ↗MalfunctionJan 16, 2025Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE INFERIOR VENA CAVA FILTER DID NOT COME OFF WHEN IT WAS DEPLOYED. IT WAS PLACED BACK INTO THE SHEATH AND REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER IGTCFS-65-1-JUG-TULIP FROM THE HOSPITAL INVENTORY AND IT WAS SUCCESSFULLY PLACED. THE FILTER DID NOT COME OFF THE INTRODUCER HOOK EVEN WHEN THE BLUE RELEASE BUTTON WAS PRESSED. THE FILTER WAS DEPLOYED IN THE JUGULAR VEIN, JUST BELOW THE RENAL VEIN. DUE TO THE FILTER RELEASE FAILURE, IT WAS PLACED BACK INTO THE SHEATH AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21165822 ↗InjuryDec 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2017. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20833863 ↗MalfunctionNov 14, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN THE INFERIOR VENA CAVA WAS ACCESSED FROM THE JUGULAR VEIN FOR IVC FILTER PLACEMENT, THE FILTER FAILED TO EXPAND, SO THE FILTER WAS RETURNED INTO THE SHEATH AND ABANDONED FILTER PLACEMENT. AS THERE WAS NO REPLACEMENT DEVICE AVAILABLE ON THE DAY, THE PROCEDURE WAS RESCHEDULED. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20680641 ↗MalfunctionSep 30, 2024Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE INFERIOR VENA CAVA WAS APPROACHED FROM THE RIGHT JUGULAR VEIN. AFTER DETERMINING THE PLACEMENT POSITION JUST BELOW THE RENAL VEIN, THE PHYSICIAN DEPLOYED THE FILTER AND ATTEMPTED TO RELEASE IT, BUT THE FILTER WAS NOT RELEASED, SO HE COVERED THE FILTER WITH THE SHEATH AGAIN AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF A TEMPORARY FILTER FROM ANOTHER MANUFACTURER. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20331974 ↗MalfunctionSep 30, 2024Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS WAS A CASE OF EMERGENCY SURGERY. THERE WAS A BLOOD CLOT IN BOTH LEGS AND THE RIGHT INTERNAL JUGULAR VEIN. APPROACHED FROM THE RIGHT INTERNAL JUGULAR VEIN. THE PHYSICIAN PRESSED THE RED SAFETY LOCK AND THEN THE BLUE RELEASE BUTTON BUT THE FILTER WAS NOT RELEASED. HE PRESSED THE BLUE RELEASE BUTTON SEVERAL TIMES BUT THE FILTER WAS NOT RELEASED SO THE DEVICE WAS REMOVED FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED BY USING COMPETITOR'S PRODUCT (BD/DENALI IVC FILTER) INSTEAD OF IGTCFS-65-1-JUG-TULIP. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20331847 ↗InjuryAug 7, 2024Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels
MAUDE report 19928009 ↗MalfunctionMar 13, 2024Failure to Advance; Failure to Advance
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DOCTOR WAS TRYING TO PERFORM AN INFERIOR VENA CAVA FILTER PLACEMENT. PREPPED DEVICE PER PROTOCOL. FOUND THAT WHEN HE TRIED TO UNSHEATH FILTER, THERE WAS RESISTANCE SO STOPPED AND REMOVED EVERYTHING FROM PATIENT. NO HARM TO PATIENT. A NEW FILTER WAS OPENED AND PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18892642 ↗InjuryFeb 21, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PHYSICIAN WENT TO DEPLOY THE FILTER, BUT THE FILTER WOULD NOT DEPLOY. THE PHYSICIAN WAS ABLE TO GET FILTER TO EVENTUALLY DEPLOY (THE FILTER DEPLOYED CROOKED), BUT IT TOOK A LOT OF WORK TO DO SO, IN THAT PURSUIT, THE USER HAD TO OPEN AND USE A SNARE TO REPOSITION / ALIGN THE FILTER ACCORDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18751718 ↗InjuryFeb 6, 2024Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18648692 ↗InjuryJan 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DOCTOR WAS TRYING TO DEPLOY A JUG CELECT FILTER THAT WOULD NOT DETACH (B)(4). HE HAD TO OPEN A SECOND FILTER THAT WAS A JUG TULIP AND HAD THE SAME ISSUE (B)(4). HE TRIED APPLYING FORWARD PRESSURE TO UNHOOK THE FILTER BUT THAT PUSHED THE FILTER INTO THE RENAL VEIN. HE HAD TO OPEN A RETRIEVAL SYSTEM AND RETRIEVE THIS FILTER. HE HAD TO OPEN A THIRD FILTER FOR PLACEMENT.
Patient problems: Failure of Implant
MAUDE report 18493689 ↗InjuryJan 3, 2024Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DOCTOR WAS TRYING TO DEPLOY A JUG CELECT FILTER THAT WOULD NOT DETACH (B)(4). HE HAD TO OPEN A SECOND FILTER THAT WAS A JUG TULIP AND HAD THE SAME ISSUE (B)(4). HE TRIED APPLYING FORWARD PRESSURE TO UNHOOK THE FILTER BUT THAT PUSHED THE FILTER INTO THE RENAL VEIN. HE HAD TO OPEN A RETRIEVAL SYSTEM AND RETRIEVE THIS FILTER. HE HAD TO OPEN A THIRD FILTER FOR PLACEMENT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18434507 ↗MalfunctionDec 12, 2023Premature Activation; Premature Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: APPROACHED FROM THE RIGHT JUGULAR VEIN TO THE INFERIOR VENA CAVA. THE DEVICE WAS ADVANCED TO THE IMPLANTATION POSITION AND THE FILTER WAS EXPANDED, BUT WHEN IT WAS RE-STOWED INTO THE DELIVERY SHEATH TO ADJUST THE IMPLANTATION POSITION, THE DELIVERY CATHETER (FILTER CATHETER) WAS FOUND TO BE DETACHED FROM THE FILTER. THEREFORE, THE DELIVERY CATHETER (FILTER CATHETER) WAS COMPLETELY REMOVED, A 0.014 WIRE GUIDE WAS LOOPED AND BROUGHT INTO THE SHEATH, HOOKED ONTO THE HOOK OF THE FILTER, AND THE DELIVERY SHEATH WAS REMOVED (BECAUSE IT COULD FALL OUT INTO THE BODY IF REMOVED AS IS). THE PROCEDURE WAS COMPLETED BY USING ANOTHER IGTCFS-65-1-JUG-TULIP WITH A DIFFERENT LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18309509 ↗MalfunctionDec 4, 2023Premature Activation; Improper or Incorrect Procedure or Method; Premature Activation; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2023: AFTER THE USER DEPLOYED THE FILTER, HE WAS ATTEMPTING TO RE-SHEATH THE FILTER, AND THE FILTER HOOK WAS RELEASED FROM THE FILTER CATHETER WITHOUT INTENTION. THE FILTER WAS INSIDE THE CATHETER SHEATH AT THE UNINTENDED RELEASE, SO HE REMOVED THE WHOLE SYSTEM WITH THE FILTER INSIDE FROM THE PATIENT BODY AND ENDED THE PROCEDURE. (B)(6) 2023: HE CONDUCTED ANOTHER FILTER PLACEMENT USING ANOTHER IGTCFS-65-1-JUG-TULIP AND PLACED A FILTER SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT HAD TO BE UNDER SECOND FILTER PLACEMENT NEXT DAY. ALTHOUGH THE PATIENT IS DOING FINE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18259239 ↗
Other William Cook Europe ApS products
All William Cook Europe ApS devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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