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Cook Celect G52914Recalls & reported problems

William Cook Europe ApS · Cook Celect, Vena Cava Filter, Femoral Approach · Class 2 · Implant

Quick summary

This Cook Celect vena cava filter is an implanted filter placed through the femoral vein. Its 99 adverse event reports include 2 deaths, 86 injuries and 11 malfunctions. The reports mostly describe patients alleging the filter perforated the vena cava or nearby organs, and some describe migration, fractures or difficulty removing it. No recalls name this device.

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
99
Deaths reported
2
Injuries reported
86
Recalls naming it
0

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10827002529141), received between Dec 5, 2014 and Aug 26, 2024 — classified as 2 deaths, 86 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (69 reports).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Structural Problem69
  • Appropriate Device Problem Term/Code Not Available46
  • Device Tipped Over36
  • Obstruction of Flow23
  • Difficult to Remove20
  • Detachment of Device or Device Component17
  • Unintended Movement15
  • Insufficient Device Problem Information13

Patient problems

  • Perforation of Vessels73
  • Internal Organ Perforation53
  • Insufficient Information35
  • Anxiety27
  • Pain26
  • Thrombosis/Thrombus21
  • Device Embedded In Tissue or Plaque14
  • Depression12

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 26, 2024Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement

    PRODUCT INFORMATION HAS BEEN RECEIVED.

    Patient problems: Abdominal Pain; Anxiety; Chest Pain; Device Embedded In Tissue or Plaque; Foreign Body Embolism; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 20072066 ↗
  • InjuryJan 17, 2024Structural Problem; Structural Problem

    PATIENT ALLEGEDLY RECEIVED A COOK CELECT FILTER ON (B)(6) 2012 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING "FREQUENT PAIN IN LEG; LEG GETS VERY RED/PURPLE AND BURNS; VERY WORRIED ABOUT WHAT MAY HAPPEN", AS WELL AS LIMITED PHYSICAL ACTIVITY. PER A COMPUTED TOMOGRAPHY (CT) ABDOMEN: "AN INFERIOR VENA CAVA FILTER IS PRESENT. NO TILT OF THE FILTER IS PRESENT. THE SUPERIOR TIP OF THE FILTER IS VERY NEAR THE LEFT ANTERIOR WALL OF THE INFERIOR VENA CAVA. 2 RIGHT RENAL VEINS ARE PRESENT. THE SUPERIOR TIP OF THE FILTER IS LOCATED VERY NEAR THE LEVEL OF THE TAKEOFF OF THE RIGHT RENAL VEIN. THERE IS A CLEAR FAT PLANE BETWEEN THE OUTER WALL OF THE INFERIOR VENA CAVA AND MULTIPLE STRUTS OF THE FILTER. 2 OF THE LEFT LATERAL STRUTS OF THE FILTER EXTEND THROUGH THE LEFT LATERAL WALL OF THE INFERIOR VENA CAVA AND PROJECT INTO THE ABDOMINAL AORTA. NO INFERIOR VENA CAVA STENOSIS IS PRESENT".

    Patient problems: Internal Organ Perforation; Pain; Perforation of Vessels; Skin Burning Sensation; Skin Discoloration

    MAUDE report 18527773 ↗
  • InjuryOct 2, 2023Difficult 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 PATIENT RECEIVED A COOK CELECT INFERIOR VENA CAVA (IVC) FILTER ON 14FEB2012. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Patient problems: Abdominal Pain; Distress; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels

    MAUDE report 17851254 ↗
  • InjurySep 25, 2023Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available

    THE PATIENT RECEIVED CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA RIGHT FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). THE PATIENT IS ALLEGING DEVICE FRACTURE, ORGAN/VENA CAVA PERFORATION, AND MIGRATION. THE PATIENT FURTHER ALLEGES EXPERIENCING DVT AND PE POST FILTER PLACEMENT, GROIN PAIN, DEPRESSION, ANXIETY AND LIMITED ACTIVITY. PATIENT ALLEGEDLY RECEIVED A SECOND, NON-COOK, IVC FILTER (B)(6) 2012 DUE TO THROMBUS SURROUNDING THE COOK FILTER AND RECURRENT PE. IT IS ALLEGED PATIENT REQUIRED A THROMBECTOMY PROCEDURE TO REMOVE CLOTTING IN THE IVC. PER AN ANGIOGRAM REPORT: "IMPRESSION: 1. AGE-INDETERMINATE LEFT UPPER LOBE PULMONARY EMBOLISM IS NEW FROM THE PRIOR EXAMINATION. THERE HAS BEEN INTERVAL PLACEMENT OF AN IVC FILTER. THERE IS A SMALL RESIDUAL RIGHT BASILAR SEGMENTAL PULMONARY EMBOLISM IN ALL OF THE ADDITIONAL PULMONARY EMBOLI ARE NO LONGER SEEN". PER A COMPUTED TOMOGRAPHY (CT) ANGIOGRAM REPORT: "FINDINGS: AN IVC FILTER IS PRESENT". "IMPRESSION: 1. SIGNIFICANT INTERVAL INCREASE IN PULMONARY EMBOLI. THERE IS A NEW LARGE RIGHT MAIN PULMONARY EMBOLISM WITH EXTENSION INTO ALL THREE LOBAR VESSELS AND SEVERAL NEW SEGMENTAL PULMONARY EMBOLI A

    Patient problems: Depression; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels; Pulmonary Embolism; Thrombosis/Thrombus

    MAUDE report 17809110 ↗
  • InjurySep 11, 2023Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available

    AWARE DATE CORRECTION

    Patient problems: Insufficient Information; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 17719485 ↗
  • InjuryJul 11, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

    PATIENT ALLEGEDLY RECEIVED A CELECT FILTER ON (B)(6)2012 VIA THE RIGHT COMMON FEMORAL VEIN POST PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING VENA CAVA PERFORATION AND ORGAN PERFORATION. PER A CT LUMBAR SPINE: "FINDINGS: FILTER TYPE: COOK CELECT. IVC STENOSIS: NO. FILTER POSITION: BELOW THE RENAL VEINS. FILTER MIGRATION: NONE. FILTER FRACTURE/BENDING: NO. FILTER TILT: NO. FILTER PENETRATION: YES. OTHER FINDINGS: YES. IMPRESSIONS: THE ANTERIOR STRUT PENETRATES 22 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM". "THE LEFT STRUT PENETRATES 21 MM THROUGH THE IVC WALL". "THE POSTERIOR STRUT PENETRATES 20 MM THROUGH THE IVC WALL. IT PENETRATES INTO AN INTERVERTEBRAL DISC". "THE RIGHT STRUT PENETRATES 14 MM THROUGH THE IVC WALL". "A LEFT ARM STRUT PENETRATES 14 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE AORTA". A LEFT ARM STRUT PENETRATES 13 MM THROUGH THE IVC WALL".

    Patient problems: Insufficient Information; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 17297598 ↗
  • InjuryMay 26, 2023Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

    THE PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO POST TRAUMA. THE PATIENT ADDITIONALLY ALLEGES A FAILED FILTER RETRIEVAL ATTEMPT ON (B)(6) 2013 FOLLOWED BY A SUCCESSFUL PERCUTANEOUS RETRIEVAL ON (B)(6) 2023. THE PATIENT ALLEGES LOWER BACK PAIN, VERTEBRAE PENETRATION, AND LIMITED ACTIVITY. (B)(6) 2013, PER A REPORT FROM RETRIEVAL REPORT (ATTEMPTED); ¿FINDINGS: ILIAC VENOGRAM AND INFERIOR VENACAVOGRAM DEMONSTRATES NO ILIAC OR RENAL VENOUS ANOMALIES, AND NO CAVAL ANOMALIES. CAVAL DIAMETER IS WITHIN NORMAL LIMITS. THERE IS NO THROMBUS IN THE ILIAC VEINS OR INFERIOR VENA CAVA. HOWEVER, THERE IS SIGNIFICANT FILTER TILT, WITH THE NOSE OF THE COOK CELECT FILTER ABUTTING THE LEFT ASPECT OF THE INFERIOR VENA CAVA AT THE LEVEL OF THE SUPERIOR L3 VERTEBRAL BODY. BECAUSE OF THE SIGNIFICANT TILT, RETRIEVAL WAS NOT POSSIBLE.¿ (B)(6) 2021, PER A REPORT FROM COMPUTED TOMOGRAPHY 2; ¿THE FILTER IS TILTED 45 DEGREES TO THE LEFT WITH ITS PROXIMAL CONE AGAINST THE IVC WALL. THE ANTERIOR STRUT PENETRATES 11 MM THROUGH THE IVC WALL. THE LEFT STRUT PENETRATES 10 MM THOUGH THE IVC WALL. THE POSTERIOR STRUT PENETRATES 12 MM THROUGH THE IVC WALL. IT PENETRATES

    Patient problems: Abdominal Pain; Device Embedded In Tissue or Plaque; Internal Organ Perforation; Pain; Perforation of Vessels

    MAUDE report 17009582 ↗
  • InjuryMay 26, 2023Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available

    THE PATIENT ALLEGEDLY RECEIVED AN IMPLANT (B)(6) 2012 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO POST DEEP VEIN THROMBOSIS (DVT). THE PATIENT ALLEGES MIGRATION, VENA CAVA PERFORATION, FRACTURE, ORGAN PERFORATION, STENOSIS, AND CAVAL THROMBOSIS. THE PATIENT FURTHER ALLEGES A BROKEN STRUT, AORTA PERFORATION/VEIN CAUSING EXCESS FLUID IN LEGS, LEG SWELLING/ULCERS, REQUIRED WOUND CARE TO HEAL WOUNDS, LIMITED ACTIVITY, PAIN, ANXIETY/DEPRESSION. PERCUTANEOUS FILTER REMOVAL ON (B)(6) 2021 DUE TO COMPLICATIONS/INJURIES. 06MAY2021, PER A REPORT FROM COMPUTED TOMOGRAPHY; "THERE IS AN IVC FILTER IN PLACE WITH MARKED STENOSIS OR POSSIBLY OCCLUSION OF THE INFRARENAL IVC NEAR THE JUNCTURE OF THE RIGHT AND LEFT COMMON ILIAC VEINS". "THERE IS A FRACTURED LIMB IN THE SOFT TISSUE IMMEDIATELY ADJACENT TO THE RENAL PELVIS AND PROXIMAL URETER". ¿IVC FILTER IN THE INFRARENAL IVC IS FRACTURED WITH SEVERAL FEET EXTENDING INTO SURROUNDING STRUCTURES AS DESCRIBED ABOVE INCLUDING THE RIGHT COMMON ILIAC ARTERY. THERE IS OCCLUSION OF THE INFRARENAL IVC WITH EXTENSIVE ABDOMINAL WALL VENOUS COLLATERAL CHANNELS.¿ 28OCT2021, PER A REPORT FROM RETRIEVAL REPORT (SUCCESSFUL); ¿SUCCESSFUL REMOVAL OF PARTIALLY THROMBOSED

    Patient problems: Insufficient Information; Internal Organ Perforation; Obstruction/Occlusion; Perforation of Vessels; Stenosis; Swelling/ Edema; Thrombosis/Thrombus; Ulcer

    MAUDE report 17009558 ↗
  • MalfunctionApr 19, 2023Device Tipped Over; Device Tipped Over

    PATIENT ALLEGEDLY RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER VIA THE LEFT COMMON FEMORAL VEIN ON (B)(6) 2013. PER A REPORT FROM IMPLANT REPORT; ¿WITH THESE FINDINGS, WE ADVANCED A COOK SELECT SHEATH INTO THE VENA CAVA AT THE LEVEL OF L2 AND DEPLOYED A COOK SELECT FILTER. IT WAS A BIT ANGULATED BECAUSE OF THE NATURE OF [PATIENT'S] ANATOMY. [PATIENT] HAS HAD MULTIPLE PREVIOUS ABDOMINAL SURGERIES AND HAS SCARRING AND THE CATHETER DID NOT TRACK THE ANGULATION WELL PASSED THE CONFLUENCE OF THE VENA CAVA. WE DID NOT DO COMPLETION VENOGRAPHY TO AVOID CONTRAST NEPHROPATHY".

    Patient problems: Insufficient Information

    MAUDE report 16768064 ↗
  • InjuryMar 29, 2023Structural Problem; Unintended Movement; Structural Problem; Unintended Movement

    PATIENT ALLEGEDLY RECEIVED A COOK CELECT FILTER DUE TO DEEP VEIN THROMBOSIS (DVT). PATIENT IS ALLEGING DEVICE MIGRATION AND VENA CAVA PERFORATION. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING FEAR, ANXIETY, WORRY, LIMITED PHYSICAL ACTIVITIES, DEPRESSION PER A REPORT FROM CT2: "CAVAL PERFORATION: YES. 9 O'CLOCK 7.10 MM GRADE 2. 8:30 O'CLOCK 4.70 MM GRADE 2. 7 O'CLOCK 5.80 MM. TILT: NO. MIGRATION: YES. CAVAL FILTER IS SEEN AT THE BIFURCATION. PERTINENT NEGATIVES: NONE. ADDITIONAL FINDINGS: NONE".

    Patient problems: Anxiety; Depression; Perforation of Vessels

    MAUDE report 16637646 ↗
  • InjuryJan 17, 2023Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available

    IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels; Stenosis

    MAUDE report 16184353 ↗
  • InjuryNov 7, 2022Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available

    IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Anxiety; Depression; Dyspnea; Hyperresponsive to stimuli; Insufficient Information; Internal Organ Perforation; Numbness; Obstruction/Occlusion; Pain; Perforation of Vessels; Peripheral Edema; Pulmonary Embolism; Swelling/ Edema; Thrombosis/Thrombus

    MAUDE report 15745206 ↗
  • InjurySep 16, 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 CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012, 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 15439422 ↗
  • InjurySep 2, 2022Difficult to Remove; Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available

    IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Chest Pain; Fatigue; Insufficient Information; Internal Organ Perforation; Perforation of Vessels; Thrombosis/Thrombus

    MAUDE report 15348456 ↗
  • InjuryJul 27, 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 CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Perforation of Vessels

    MAUDE report 15115618 ↗
  • InjuryJul 21, 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 INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2010, 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 15075069 ↗
  • InjuryJun 28, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Difficult to Remove; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement

    THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014. APPROXIMATELY SIX YEARS AND FIVE MONTHS, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) TEST WHICH REVEALED THAT THE FILTER MIGRATED AND PERFORATED THE IVC WITH MULTIPLE LIMBS OF THE FILTER PROJECTING BEYOND THE CONFINES OF THE VESSEL LUMEN. IT ALSO REVEALED THAT THE FILTER HAD FRACTURED WITH ONE OF THE BROKEN LIMBS OF THE FILTER BEING LODGED IN THE LOWER POLE OF THE RIGHT KIDNEY AND ONE BROKEN LIMB LOCATED WITHIN THE RIGHT MIDDLE LOBE LUNG PARENCHYMA. FURTHERMORE THE FOLLOWING MONTH, THE PATIENT UNDERWENT AN COMPLEX FILTER REMOVAL SURGERY DUE TO TILTING AND SUBSEQUENT INJURIES RESULTING IN UNSUCCESSFUL REMOVAL OF THE EMBEDDED FRAGMENT. THE PATIENT FURTHER ALLEGES PAIN, DISTRESS, AND LIMITED MOBILITY. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Device Embedded In Tissue or Plaque; Distress; Foreign Body In Patient; Internal Organ Perforation; Pain; Perforation of Vessels

    MAUDE report 14846305 ↗
  • MalfunctionJun 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6)2011, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Discomfort; Dizziness; Dyspnea; Insufficient Information

    MAUDE report 14618055 ↗
  • InjuryMay 25, 2022Difficult to Remove; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Difficult to Remove; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component

    THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011. THE PATIENT'S IVC FILTER SUBSEQUENTLY FRACTURED AND TILTED RESULTING IN DIFFUSE FILTER STRUT PENETRATION INTO THE CAVAL WALL. ALSO, A SINGLE FILTER TINE BECAME EMBEDDED IN THE RIGHT LUNG. THE PATIENT FURTHER ALLEGES PAIN AND MENTAL DISTRESS. APPROXIMATELY EIGHT YEARS AND ONE MONTH LATER, THE PATIENT UNDERWENT A COMPLEX FILTER RETRIEVAL PROCEDURE, HOWEVER A FRACTURED PORTION OF THE FILTER COULD NOT BE REMOVED. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Anxiety; Chest Pain; Depression; Device Embedded In Tissue or Plaque; Embolism/Embolus; Foreign Body In Patient; Pain; Perforation of Vessels; Thrombosis/Thrombus; Unspecified Mental, Emotional or Behavioral Problem

    MAUDE report 14497653 ↗
  • InjuryMay 25, 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 CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012, 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 14497470 ↗
  • InjuryMay 25, 2022Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available

    IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Aneurysm; Insufficient Information; Perforation of Vessels; Pulmonary Hypertension; Swelling/ Edema; Thrombosis/Thrombus

    MAUDE report 14496932 ↗
  • InjuryMay 19, 2022Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component

    IT IS ALLEGED THAT "PATIENT RECEIVED A COOK CELECT FILTER. PATIENT IS ALLEGING PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Patient problems: Anxiety; Internal Organ Perforation; Perforation of Vessels; Thrombosis/Thrombus

    MAUDE report 14445066 ↗
  • InjuryMay 19, 2022Structural Problem; Structural Problem

    IT IS ALLEGED THAT "PATIENT RECEIVED A COOK CELECT FILTER. PATIENT IS ALLEGING PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Patient problems: Internal Organ Perforation

    MAUDE report 14445021 ↗
  • 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 14444911 ↗
  • InjuryMay 19, 2022Inadequate 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

    IT IS ALLEGED THAT "PATIENT RECEIVED A COOK CELECT FILTER. PATIENT IS ALLEGING FRACTURE. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Patient problems: Anxiety; Insufficient Information; Perforation of Vessels; Pulmonary Embolism; Thrombosis/Thrombus

    MAUDE report 14444851 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.