Gunther Tulip G52918Recalls & reported problems
William Cook Europe ApS · Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach · Class 2 · Implant
All models of Gunther Tulip (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Gunther Tulip vena cava filter set is implanted to trap blood clots in the inferior vena cava. The 67 reports mostly describe difficulty releasing or deploying the filter from its delivery system, filters tipping over or sitting in the wrong spot, and trouble removing them later, along with vessel perforation. One report mentions a death and 37 mention injuries. One recall, started in February 2022 and closed, updated the labeling to revise the device description, indications, contraindications, warnings and potential adverse events.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 67
- Deaths reported
- 1
- Injuries reported
- 37
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10827002529189), received between May 10, 2016 and Mar 13, 2024 — classified as 1 death, 37 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (20 reports).
1 FDA recall record name this device's 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, 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.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Structural Problem20
- Appropriate Device Problem Term/Code Not Available15
- Difficult to Remove10
- Malposition of Device9
- Insufficient Device Problem Information8
- Device Tipped Over7
- Difficult or Delayed Activation6
- Difficult or Delayed Positioning6
Patient problems
- Perforation of Vessels20
- No Known Impact Or Consequence To Patient19
- Anxiety10
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions10
- Internal Organ Perforation9
- No Consequences Or Impact To Patient8
- Pain8
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryNov 6, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; Perforation of Vessels; Peripheral Edema
MAUDE report 18073558 ↗InjuryJan 23, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER WOULD NOT COME OFF THE DEPLOYMENT SYSTEM. ANOTHER IGTCFS-65-1-UNI-TULIP WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. ACCESS WAS IN THE JUGULAR TO BE ABLE TO RETRIEVE THE SYSTEM THROUGH THE PATIENTS NECK. THE FILTER WAS DEPLOYED WITH FEMORAL APPROACH AND DESIRED PLACEMENT SITE WAS IVC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16222800 ↗InjuryAug 3, 2022Difficult or Delayed Activation; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN PLACED FILTER, NO DEVIATION FROM HOW HE ALWAYS PLACES THEM, FROM THE RIGHT FEMORAL VEIN APPROACH. MESSAGE WAS THAT THE RED ¿LOCK¿ ON THE IVC FILTER WASN¿T WORKING PROPERLY. THE FILTER WOULD NOT DEPLOY AND THEN IT ENDED UP DEPLOYING IN THE SHEATH. THEY TRIED TO RESHEATH IT SINCE IT WAS ONLY PARTIALLY OUT OF THE SHEATH, HOWEVER THAT JUST MESSED THE SECONDARY STRUTS UP. ULTIMATELY, THE PHYSICIAN GOT INTERNAL JUGULAR ACCESS AND HAD TO SNARE THE SHEATH TO HOLD IT IN PLACE WHILE THE TECH SLOWLY RETRACTED THE DEPLOYMENT SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15159101 ↗InjuryAug 1, 2022Improper 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 PHYSICIAN PLACED FILTER ¿ NO DEVIATION FROM HOW HE ALWAYS PLACES THEM, FROM THE RIGHT FEMORAL VEIN APPROACH. MESSAGE WAS THAT THE RED ¿LOCK¿ ON THE IVC FILTER WASN¿T WORKING PROPERLY. THE FILTER WOULD NOT DEPLOY AND THEN IT ENDED UP DEPLOYING IN THE SHEATH. THEY TRIED TO RESHEATH IT SINCE IT WAS ONLY PARTIALLY OUT OF THE SHEATH, HOWEVER THAT JUST MESSED THE SECONDARY STRUTS UP. ULTIMATELY, THE PHYSICIAN GOT INTERNAL JUGULAR ACCESS AND HAD TO SNARE THE SHEATH TO HOLD IT IN PLACE WHILE THE TECH SLOWLY RETRACTED THE DEPLOYMENT SHEATH. PATIENT OUTCOME: THE PHYSICIAN LEFT THE FILTER IN PLACE, AND WILL RETRIEVE IN A FEW WEEKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15137644 ↗MalfunctionJul 8, 2022Difficult or Delayed Activation; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN THE PHYSICIAN TRIED TO DEPLOY THE FILTER, IT WOULD NOT COME OFF OF THE JUGULAR DEPLOYMENT SYSTEM. THE FILTER WOULD NOT COME OFF AFTER PUSHING THE RELEASE. A NEW G52918-IGTCFS-65-1-UNI-TULIP WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14954272 ↗InjuryJun 21, 2022Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2018, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Insufficient Information; Perforation of Vessels
MAUDE report 14754195 ↗InjuryJun 15, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2017, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14696099 ↗InjuryJun 8, 2022Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2018, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Bowel Perforation; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels
MAUDE report 14633885 ↗InjuryJun 7, 2022Difficult to Remove; Structural Problem; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2017, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Anxiety; Insufficient Information; Internal Organ Perforation
MAUDE report 14623741 ↗DeathJun 6, 2022Obstruction of Flow; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2016, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. THE PATIENT HAS REPORTEDLY EXPIRED. SPECIFIC DETAILS SURROUNDING THE PATIENT'S EXPIRATION ARE CURRENTLY UNKNOWN, AND THERE IS CURRENTLY NO REPORTED ALLEGATION OF WRONGFUL DEATH. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Abdominal Pain; Anxiety; Chest Pain; Depression; Dyspnea; Insufficient Information; Pain; Perforation of Vessels; Thrombosis/Thrombus
MAUDE report 14603522 ↗InjuryMay 19, 2022Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Abdominal Pain; Anxiety; Depression; Device Embedded In Tissue or Plaque; Perforation; Perforation of Vessels; Thrombosis/Thrombus
MAUDE report 14444747 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PE. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Pulmonary Embolism
MAUDE report 14444576 ↗InjuryMay 19, 2022Structural Problem; Device Tipped Over; Unintended Movement; Structural Problem; Device Tipped Over; Unintended Movement
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Anxiety; Perforation of Vessels
MAUDE report 14444574 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Internal Organ Perforation; Perforation of Vessels
MAUDE report 14444270 ↗InjuryMay 19, 2022Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING FILTER PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Anxiety; Internal Organ Perforation; Perforation of Vessels
MAUDE report 14444116 ↗InjuryMay 19, 2022Structural Problem; Structural Problem
IT IS ALLEGED THAT "PATIENT RECEIVED A COOK CELECT FILTER. PATIENT IS ALLEGING PERFORATION PF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."
Patient problems: Perforation of Vessels
MAUDE report 14443866 ↗InjuryMar 28, 2022Obstruction of Flow; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2018 , AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels; Stenosis
MAUDE report 13933877 ↗InjuryMar 9, 2022Difficult to Remove; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Detachment of Device or Device Component; Unintended Movement; Difficult to Remove; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Detachment of Device or Device Component; Unintended Movement
THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2015. THE PATIENT'S IVC FILTER FRACTURED AND SEVERAL PRONGS PERFORATED THE IVC AND FURTHER PERFORATED AND ABUTTED OTHER ORGANS. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE FILTER BUT A FRAGMENT REMAINS EMBEDDED IN THE SPINE. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Anxiety; Depression; Device Embedded In Tissue or Plaque; Internal Organ Perforation; Perforation of Vessels; Pulmonary Embolism; Stenosis; Thrombosis/Thrombus
MAUDE report 13712439 ↗InjuryMar 9, 2022Difficult to Remove; Structural Problem; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2015, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Cramp(s) /Muscle Spasm(s); Fatigue; Headache; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Perforation of Vessels
MAUDE report 13711865 ↗InjuryFeb 25, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2016, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Insufficient Information; Internal Organ Perforation; Perforation of Vessels
MAUDE report 13605111 ↗InjuryFeb 11, 2022Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2015, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.
Patient problems: Anxiety; Insufficient Information; Perforation of Vessels
MAUDE report 13517735 ↗InjuryDec 7, 2021Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: A PATIENT UNDERWENT AN IVC FILTER PLACEMENT PROCEDURE IN WHERE A GUNTHER TULIP VENA CAVA FILTER WAS PLACED, ACCESS ACHIEVED VIA RIGHT GROIN. THE TECH ASKED THE DISTRICT MANAGER IF THE FILTER WOULD DEPLOY WITHOUT PUSHING THE RED BUTTON. DISTRICT MANAGER ADVISED THE RED BUTTON HAD TO BE PUSHED. WHEN REMOVING THE FILTER IT WAS NOTED THAT THE FILTER DID NOT FULLY DEPLOY. THE FILTER WAS RE-SHEATHED AND WENT OVER ALL OF FILTER EXCEPT THE HOOK. WHEN TRYING TO REMOVE THE HOOK GOT CAUGHT ON THE FILTER. THE PHYSICIAN CUT THE DEVICE OUTSIDE OF THE PATIENT WITH WIRE CUTTERS. THEN USED AN 11FR SHEATH, UNKNOWN MANUFACTURE, AND WAS ABLE TO COVER THE HOOK AND REMOVED SUCCESSFULLY. SUTURED UP THE RIGHT GROIN. USED A CELECT UNI FILTER ON LEFT SIDE TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: NO ADDITIONAL INFORMATION REGARDING THE PATIENTS OUTCOME HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12955234 ↗InjuryDec 7, 2021Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure
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 12947708 ↗InjuryJun 11, 2021Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: GAINED ACCESS AND TOOK SEVERAL VENOGRAMS WHICH WERE NORMAL. TRIED TO DEPLOY THE FILTER BUT WHEN FILTER WAS RELEASED IT FAILED TO OPEN UP. WHILE THEY WERE PREPARING JUGULAR ACCESS TO RETRIEVE FILTER, THE PHYSICIAN PRODDED THE FILTER WITH THE SHEATH AND IT OPENED UP. THE HOOK ENDED UP IN THE RIGHT RENAL VEIN. THEY WERE UNSURE WHETHER THE FILTER JUMPED UP TO THE LEVEL OF THE RENALS OR WHETHER THE BLOOD FLOW CARRIED IT UP TO THE RENALS. THEY ATTEMPTED TO RETRIEVE THE HOOK BY FEMORAL ACCESS USING THE GTRS RETRIEVAL KIT TO PULL IT OUT OF THE RENAL VEIN BUT WERE UNSUCCESSFUL. THEY FINISHED PROCEDURE WITHOUT FURTHER INCIDENT. NO FURTHER INTERVENTION IS PLANNED AT THIS TIME. THE PHYSICIAN IS GOING TO CONSULT WITH PATIENT¿S ONCOLOGIST REGARDING HIS LONG TERM PROGNOSIS WITH CANCER TO DETERMINE ADVISABILITY OF ATTEMPTING FILTER RETRIEVAL AT A LATER DATE. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11981977 ↗
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 · each recall links to the FDA recall notice
- 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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