Cook Celect G34309Recalls & reported problems
William Cook Europe ApS · Celect Platinum Vena Cava Filter Set for Jugular Vein Approach · Class 2 · Implant
All models of Cook Celect (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Celect filter set has 230 adverse event reports, including 146 malfunctions, 80 injuries and 1 death. The reports mostly describe the filter not releasing or deploying properly and tilting into the vessel wall, with some describing vessel perforation. 1 recall, started in February 2022 and now closed, was a labeling update. Reports fell from 6 in the previous 12 months to 1 in the most recent 12 months.
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
- 230
- Deaths reported
- 1
- Injuries reported
- 80
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 10827002343099), received between Feb 15, 2016 and Dec 10, 2025 — classified as 1 death, 80 injuries, 146 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (34 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 16, 2026.
Reports received per month
Recalls naming this device
- Feb 14, 2022Terminated
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Z-0876-2022 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available45
- Malposition of Device34
- Difficult or Delayed Activation31
- Activation Failure25
- Structural Problem20
- Device Tipped Over19
- Difficult to Remove19
- Difficult or Delayed Positioning15
Patient problems
- No Known Impact Or Consequence To Patient64
- No Consequences Or Impact To Patient59
- Perforation of Vessels42
- No Clinical Signs, Symptoms or Conditions41
- Internal Organ Perforation15
- Insufficient Information14
- No Information10
- No Code Available7
Recent adverse event reports
The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Activation Problem; Activation Problem
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNKNOWN PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET, G34309, WAS USED. DEVICE WAS PREPPED PER PROTOCOL. FILTER WOULD NOT RELEASE FROM HOOK UPON PRESSING BLUE BUTTON. RE-SHEATHED FILTER AND REMOVED FROM THE SHEATH. DEPLOYED FILTER ON TABLETOP. OPENED NEW FILTER AND WAS ABLE TO DEPLOY THAT FINE. PATIENT OUTCOME: NO ADDITIONAL PROCEDURES NECESSARY. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23765994 ↗InjurySep 19, 2025Device Tipped Over; Device Tipped Over
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INFERIOR VENA CAVA (IVC) FILTER DEPLOYMENT WAS UNSUCCESSFUL. TWO RETRIEVAL SETS WERE UTILIZED TO REMOVE THE FILTER. A NEW ACCESS SITE WAS ESTABLISHED, AND A SECOND DEVICE OF THE SAME TYPE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: DELAY WITH UNKNOWN OF THE LENGHT OF TIME. WHAT WAS THE INDICATION FOR FILTER PLACEMENT? PE PREVENTION. IF KNOWN, HOW LONG WAS THE FILER IMPLANTED IN THE PATIENT? FEW MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096241 ↗InjurySep 5, 2025Device Tipped Over; Activation Problem; Device Tipped Over; Activation Problem
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INFERIOR VENA CAVA (IVC) FILTER DEPLOYMENT WAS UNSUCCESSFUL. TWO RETRIEVAL SETS WERE UTILIZED TO REMOVE THE FILTER. A NEW ACCESS SITE WAS ESTABLISHED, AND A SECOND DEVICE OF THE SAME TYPE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: DELAY WITH UNKNOWN OF THE LENGTH OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976479 ↗InjuryApr 29, 2025Device Tipped Over; Device Tipped Over
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 86-YEAR-OLD FEMALE UNDERWENT A FILTER PLACEMENT PROCEDURE IN WHICH A G34309-IGTCFS-65-1-JUG-CELECT-PT, WAS USED. THE FILTER DID NOT DEPLOY CORRECTLY. IT WAS TILTED INTO THE WALL. A GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET HAD TO BE USED TO RETRIEVE THE FILTER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER G34309-IGTCFS-65-1-JUG-CELECT-PT. ADDITIONAL INFORMATION RECEIVED 10JAN2025: THE FILTER WAS DEPLOYED VIA JUGULAR APPROACH. DURING IMPLANTATION PROCEDURE DIFFICULTIES WERE XTREME TILT BUT NO PERFORATION WERE ENCOUNTERED. THE FILTER WAS RETRIEVED WITH FILTER RETRIEVAL SETS AND SHEATHS. THEY HAD TO USE MULTIPLE TYPES OF RETRIEVAL SETS. THE TILT WAS OBSERVED RIGHT AFTER DEPLOYMENT THE TILT DID EVOLVE DURING FOLLOW UP IMAGES FROM THE INITIAL IMPLANT ORIENTATION. PATIENT OUTCOME: DELAY, THE RETRIEVAL AND HAD TO DO ANOTHER PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21924293 ↗MalfunctionFeb 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 52-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET, G34309, WAS USED. THE FILTER PUNCTURED THROUGH TO DISTAL END OF THE SHEATH BEFORE THEY WERE READY TO DEPLOY. THE CASE WAS ABLE TO BE COMPLETED ONCE THE FAULTY DEVICE WAS REMOVED AND A NEW DEVICE WAS OPENED. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21311776 ↗MalfunctionNov 12, 2024Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE DEPLOYMENT THE PHYSICIAN NOTICED ONE FOOT OF THE FILTER WOULD NOT EXPAND. DECISION WAS MADE TO REMOVE THE DEFECTIVE DEVICE. A SECOND FILTER WAS OPENED AND DEPLOYED WITHOUT ISSUE. 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 20664461 ↗InjuryNov 6, 2024Activation Failure; Activation Failure
ACCORDING TO THE INITIAL REPORTER, DURING THE DEPLOYMENT, THE PHYSICIAN NOTICED ONE FOOT OF THE FILTER WOULD NOT EXPAND. DECISION WAS MADE TO REMOVE THE DEFECTIVE DEVICE. A SECOND FILTER WAS OPENED AND DEPLOYED WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620943 ↗InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT PLATINUM INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2019. 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 20532483 ↗MalfunctionSep 27, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHILE THE PHYSICIANS WERE TRYING TO DEPLOY THE FILTER, THE ARMS OPENED UP BUT THE LEGS DID NOT. LIKE THEY WERE CAUGHT ON EACH OTHER. THE PHYSICIANS HAD TO RETRIEVE IT AND PLACE A NEW FILTER. ONCE RETRIEVED, WHEN THEY PULLED IT OUT OF THE SHEATH, THE LEGS OF THE FILTER OPENED. PATIENT OUTCOME THE CASE WAS ABLE TO BE COMPLETED AND FURTHER INTERVENTIONS WERE NOT NEEDED BECAUSE OF THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20319780 ↗InjuryMay 14, 2024Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A FILTER PLACEMENT PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET, G34309, WAS USED. THE PATIENT HAD BILATERAL CLOTS IN WHICH ONE HAD DISLODGED. PATIENT HAS COLON CANCER AND IS SCHEDULED TO UNDERGO COLON RESECTION ON (B)(6) 2024 AND THE PHYSICIAN WANTED THE FILTER PLACED AS A PRECAUTION FOR PULMONARY EMBOLISM. DURING THE FILTER PLACEMENT PROCEDURE, THE PHYSICIAN FIRED THE FILTER INTO PLACE AND THE TINES DID NOT EXPAND. THE FILTER THEN TIPPED WHERE THE PHYSICIAN INTENDED TO DEPLOY THE FILTER. AFTER THE FILTER TIPPED THE TINES EXPANDED. ATTEMPTS WERE MADE TO MOVE AND REALIGN, HOWEVER THE TIP OF THE FILTER WAS POINTING INTO THE VENA CAVA WALL AND COULD NOT BE MOVED, AND THE PHYSICIAN HAD TO LEAVE THE FILTER IN PLACE. A RETRIEVAL WIRE COULD NOT BE USED AS THE FILTER TIP WAS IN THE VENA CAVA WALL. A SECOND FILTER WAS THEN DEPLOYED BELOW THE FIRST FILTER THAT WAS TILTED. THE PHYSICIAN CONFIRMED THE PATIENT IS DOING WELL, BUT THERE IS CONCERN OF THE TILTED FILTER AND THE TIP IN THE VENA CAVA WALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19308520 ↗InjuryApr 23, 2024Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A FILTER PLACEMENT PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET, (B)(6), WAS USED. THE PATIENT HAD BILATERAL CLOTS IN WHICH ONE HAD DISLODGED. PATIENT HAS COLON CANCER AND IS SCHEDULED TO UNDERGO COLON RESECTION ON (B)(6) 2024 AND THE PHYSICIAN WANTED THE FILTER PLACED AS A PRECAUTION FOR PULMONARY EMBOLISM. DURING THE FILTER PLACEMENT PROCEDURE, THE PHYSICIAN FIRED THE FILTER INTO PLACE AND THE TINES DID NOT EXPAND. THE FILTER THEN TIPPED WHERE THE PHYSICIAN INTENDED TO DEPLOY THE FILTER. AFTER THE FILTER TIPPED THE TINES EXPANDED. ATTEMPTS WERE MADE TO MOVE AND REALIGN, HOWEVER THE TIP OF THE FILTER WAS POINTING INTO THE VENA CAVA WALL AND COULD NOT BE MOVED, AND THE PHYSICIAN HAD TO LEAVE THE FILTER IN PLACE. A RETRIEVAL WIRE COULD NOT BE USED AS THE FILTER TIP WAS IN THE VENA CAVA WALL. A SECOND FILTER WAS THEN DEPLOYED BELOW THE FIRST FILTER THAT WAS TILTED. THE PHYSICIAN CONFIRMED THE PATIENT IS DOING WELL, BUT THERE IS CONCERN OF THE TILTED FILTER AND THE TIP IN THE VENA CAVA WALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19162033 ↗InjurySep 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT PLATINUM (PT) INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2015. 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 17833103 ↗InjuryAug 7, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2023 - DIFFICULT DEPLOYMENT OF A CELECT PLATINUM FILTER. ADDITIONAL INFORMATION RECEIVED 28JUL2023: FILTER DIDN¿T DEPLOY FROM THE HOOK INITIALLY. PATIENT OUTCOME: THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: THEY HAD TO RETRIEVE THE MAL-DEPLOYED FILTER AND PLACE ANOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17469079 ↗MalfunctionAug 2, 2023Improper 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: ON (B)(6) 2023 - DIFFICULT DEPLOYMENT OF A CELECT PLATINUM FILTER. ADDITIONAL INFORMATION RECEIVED 28JUL2023: FILTER DIDN¿T DEPLOY FROM THE HOOK INITIALLY. PATIENT OUTCOME: THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: THEY HAD TO RETRIEVE THE MAL-DEPLOYED FILTER AND PLACE ANOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17441450 ↗MalfunctionJul 20, 2023Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: LOT E4393441 WOULD NOT DETACH AND LOT E4391727 LEGS WOULD NOT OPEN ALL THE WAY. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: PHYSICIAN PLACED AN FILTER FROM ANOTHER MANUFACTURER. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17359974 ↗MalfunctionMay 16, 2023Difficult or Delayed Activation; 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 16937424 ↗MalfunctionMay 2, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PATIENT WAS UNDERGOING PLANNED PLACEMENT OF AN INFERIOR VENA CAVA (IVC) FILTER THROUGH JUGULAR VEIN. A J-WIRE WAS ADVANCED UNDER FLUORO AND ITS TRAJECTORY CONFIRMED TO BE IN THE IVC. THE DEVICE WAS PREPPED AND THE DEVICE SHEATH ADVANCED OVER WIRE INTO ABDOMINAL IVC. THE FILTER DEVICE WAS THEN ADVANCED OVERWIRE AND ATTEMPTED TO BE DEPLOYED HOWEVER DESPITE APPROPRIATE DEPLOYMENT SEQUENCE, THE FILTER DID NOT COME FREE OF THE DELIVERY SYSTEM. IT WAS THEREFORE RE-SHEATED AND WITHDRAWN. ON THE BACK TABLE IT WAS ATTEMPTED TO BE DEPLOYED BUT DID NOT COME FREE READILY AND HAD TO BE MANUALLY PULLED OFF THE TRIGGER WIRE. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16852486 ↗MalfunctionApr 24, 2023Difficult or Delayed Activation; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER WOULD NOT DEPLOY BECAUSE THE HOOK WOULD NOT DISENGAGE FROM THE FILTER. ANOTHER FILTER WAS GRABBED OFF THE SHELF (SAME ONE) AND COMPLETED SUCCESSFULLY. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16793931 ↗InjuryApr 17, 2023Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over
PATIENT ALLEGEDLY RECEIVED A CELECT PLATINUM (PT) IVC FILTER ON 10APR2017 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO HISTORY OF DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION, AND TILT. PATIENT ALSO ALLEGES "ABDOMINAL PAIN AND DISCOMFORT." PER CT REPORT, "IVC FILTER WITH: 5 MM PSOAS MUSCLE, AND 3 MM MESENTERIC PERFORATION. TILTING WITH THE APEX AGAINST THE IVC WALL. NO FRACTURE, STENOSIS, OR MIGRATION."
Patient problems: Abdominal Pain; Discomfort; Internal Organ Perforation; Perforation of Vessels
MAUDE report 16756132 ↗InjuryJan 18, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available
PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2016 VIA THE RIGHT INTERNAL JUGULAR DUE TO POST TRAUMA. THE PATIENT ALLEGES ORGAN AND VENA CAVA PERFORATION. THE PATIENT FURTHER ALLEGES PAIN ON RIGHT SIDE, RESTLESSNESS, AND LOSS OF BREATH. ON 29JAN2021, PER A REPORT FROM COMPUTED TOMOGRAPHY 2; ¿IMPRESSIONS: THE ANTERIOR STRUT PENETRATES 8 MM THROUGH THE IVC WALL. THE LEFT STRUT PENETRATES 8 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE AORTA. THE POSTERIOR STRUT PENETRATES 5 MM THROUGH THE IVC WALL. THE RIGHT PENETRATES 10 MM THROUGH THE IVC WALL.¿
Patient problems: Dyspnea; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels
MAUDE report 16194162 ↗InjuryJan 13, 2023Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement
19DEC2020, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿COOK CELECT FILTER. CAVAL PERFORATION: YES. 8 O'CLOCK 7.0 MM GRADE 2. 9 O'CLOCK 6.3 MM GRADE 2. TILT: NO. MIGRATION: YES. SUPERIOR STRUTS OF THE CAVAL FILTER EXTEND SUPERIOR TO THE RENAL VEINS. ADDITIONAL FINDINGS: NOTE THAT THERE IS AN INFRARENAL CAVAL GRAFT, CAVAL FILTER IS PARTIALLY WITHIN THE GRAFT AND PARTIALLY SUPERIOR TO THE GRAFT. THERE IS DISCONTINUITY OF THE GRAFT WITH MULTIPLE FRACTURED FRAGMENTS WITHIN THE GRAFT. RADIOPAQUE MATERIAL SEEN WITHIN THE GRAFT CONSISTENT WITH CHRONIC THROMBUS.¿
Patient problems: Anxiety; Depression; Device Embedded In Tissue or Plaque; Obstruction/Occlusion; Perforation of Vessels; Pulmonary Embolism; Stenosis; Thrombosis/Thrombus
MAUDE report 16162656 ↗InjurySep 9, 2022Difficult to Open or Close; Difficult to Open or Close
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER WOULD NOT OPEN AND A RETRIEVAL KIT THEN HAD TO BE OPENED AND THE FILTER REMOVED. ANOTHER FILTER THEN HAD TO BE OPENED AND THIS ONE HAD NO ISSUES. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15394953 ↗InjurySep 8, 2022Difficult to Open or Close; Activation Failure; Difficult to Open or Close; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER WOULD NOT OPEN AND A RETREIVAL KIT THEN HAD TO BE OPENED AND THE FILTER REMOVED. ANOTHER FILTER THEN HAD TO BE OPENED AND THIS ONE HAD NO ISSUES. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15378693 ↗InjuryAug 29, 2022Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT PLATINUM (PT) 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: Anxiety; Depression; Insufficient Information; Perforation of Vessels
MAUDE report 15315498 ↗MalfunctionAug 26, 2022Difficult to Remove; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available
IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT PLATINUM (PT) 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; Pain; Thrombosis/Thrombus
MAUDE report 15303073 ↗
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
- Gunther Tulip G52916William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths189 reports
- Cook Celect G34502William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths165 reports
- Cook Celect G34505William Cook Europe ApS · FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death131 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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