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Cook Celect G48373Recalls & reported problems

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

Quick summary

This Cook Celect filter is a device placed in a large vein in the abdomen to catch blood clots. Its 78 reports include 1 death and 61 injuries, and many describe the filter tilting, embedding in the vein wall, or being hard to remove, with some describing the vein or organs being pierced. Many reports are legal claims alleging these problems, and some describe filter pieces found in the body. 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
78
Deaths reported
1
Injuries reported
61
Recalls naming it
0

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00827002483736), received between Oct 14, 2011 and Sep 19, 2023 — classified as 1 death, 61 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (41 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.

Most reported problems

Device problems

  • Structural Problem41
  • Device Tipped Over29
  • Appropriate Device Problem Term/Code Not Available26
  • Difficult to Remove25
  • Malposition of Device12
  • Detachment of Device or Device Component11
  • Obstruction of Flow11
  • Insufficient Device Problem Information10

Patient problems

  • Perforation of Vessels48
  • Internal Organ Perforation36
  • Anxiety21
  • Insufficient Information14
  • Pain12
  • Device Embedded In Tissue or Plaque9
  • Stenosis9
  • Depression7

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

  • InjurySep 19, 2023Difficult 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

    IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA FILTER (IVC) ON (B)(6) 2011. APPROXIMATELY 4 MONTHS LATER, THE PATIENT UNDERWENT INITIAL VENOGRAPHY WITH THE INTENTION OF REMOVING THE FILTER. BUT, BECAUSE VENOGRAPHY SHOWED THE FILTER TO BE SLIGHTLY TILTED WITH THE HOOK OF THE FILTER EMBEDDED IN THE INFERIOR VENA CAVA WALL WHICH PREVENTED ALL ABILITY TO REMOVE IT, THE FILTER WAS LEFT IN PLACE AS A PERMANENT FILTER. APPROXIMATELY 10 YEARS LATER, THE CELECT IVC FILTER BROKE AND PIECES FLOWED INTO THE PATIENT'S BLOODSTREAM, INCLUDING A PIECE THAT PIERCED THE HEART. THE PATIENT EXPERIENCED IMMEDIATE PAIN AND DISCOMFORT AND WAS IMMEDIATELY EVALUATED IN [HOSPITAL] WHERE A BROKEN PIECE WAS FOUND IN THE HEART. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE, THE FOLLOWING DAY, A PHYSICIAN STOPPED THE BLEED AND CLOSED THE HOLE. HOWEVER, THE PIECE IN THE PATIENT'S HEART WAS NOT ABLE TO BE REMOVED. IT WAS DISCOVERED ADDITIONAL PIECES HAD BROKEN OFF AND TRAVELED THROUGHOUT THE PATIENT'S BODY WHICH THE PHYSICIAN COULD NOT REMOVE. APPROXIMATELY ONE MONTH LATER AN ABDOMINAL SURGERY WAS PERFORMED TO REMOVE THE PIECES; HOWEVER, THERE WERE THREE PIECES WHICH COULD NOT BE REMOVED

    Patient problems: Anxiety; Device Embedded In Tissue or Plaque; Discomfort; Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation; Pain; Perforation of Vessels

    MAUDE report 17773362 ↗
  • InjuryJul 11, 2023Obstruction 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

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS (DVT)/ PULMONARY EMBOLISM. PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION, AND TILT. PATIENT ALLEGES "SHARP PAINS, SWELLING IN THE AREA, LEG PAIN." PATIENT CAN NO LONGER ENGAGE IN "LEFT WEIGHTS, SQUAT, WALKING LONG PERIOD OF TIME." "ONE DVT BEFORE [FILTER IMPLANT] BROKE OFF WENT TO MY CHEST HAD SOME AFTER THE IVC FILTER". PER COMPUTED TOMOGRAPHY (CT) REPORT, "IVC: EVIDENCE FOR AN INFRARENAL VENA CAVA FILTER. THE CEPHALAD APEX IS APPROXIMATELY 1 CM CAUDAL TO THE LOWER, LEFT RENAL VEIN. THERE IS LEFTWARD TILT OF THE LONG AXIS WITH THE APEX ABUTTING THE LEFT LATERAL WALL OF THE IVC. THERE IS NO CONVINCING EVIDENCE FOR A SIGNIFICANTLY BENT OR FRACTURED FILTER STRUT. THERE IS EVIDENCE FOR FILTER STRUT PERFORATION ALONG THE RIGHT ANTEROLATERAL ASPECT WITH SINGLE STRUT EXTENDING APPROXIMATELY 2.7 MM BEYOND THE IVC INTO THE ADJACENT ADIPOSE TISSUES. EVIDENCE FOR FILTER STRUT PERFORATION ALONG THE RIGHT POSTERIOR LATERAL ASPECT OF THE IVC EXTENDING APPROXIMATELY 2.8 MM BEYOND THE IVC ABUTTING THE VENTRAL SURFACE OF THE RIGHT PSOAS. NO EVIDENCE OF INFERIOR VENA CAVA STENOSI

    Patient problems: Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels; Swelling/ Edema; Thrombosis/Thrombus

    MAUDE report 17297636 ↗
  • InjuryJun 13, 2023Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

    PATIENT ALLEGEDLY RECEIVED A CELECT IVC FILTER ON (B)(6) 2011 VIA THE RIGHT FEMORAL VEIN DUE TO MOTOR VEHICLE ACCIDENT, FOLLOWED BY AN UNSUCCESSFUL, PERCUTANEOUS RETRIEVAL ATTEMPT ON (B)(6) 2011.THE PATIENT IS ALLEGING ORGAN/VC PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED AND TILT. THE PATIENT FURTHER ALLEGES EMOTIONAL DISTRESS, MENTAL ANGUISH AND LIMITED PHYSICAL ACTIVITY.

    Patient problems: Device Embedded In Tissue or Plaque; Emotional Changes; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 17119993 ↗
  • InjuryApr 24, 2023Structural Problem; Detachment of Device or Device Component; Unintended Movement; Structural Problem; Detachment of Device or Device Component; Unintended Movement

    THE PATIENT ALLEGEDLY RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012 VIA THE RIGHT FEMORAL VEIN. (B)(6) 2013, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿IMPRESSION: OVERALL UNCHANGED POSITION OF THE INFERIOR VENA CAVA FILTER AT LEVEL OF L1-L2. SEVERAL OF THE FILTER ANCHOR TIPS APPEAR TO COURSE BEYOND THE MARGINS OF THE CAVAL WALL.¿. (B)(6) 2013, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿THERE IS AN IVC FILTER IN PLACE. SEGMENTS OF THE FILTER LEGS APPEAR TO PASS THROUGH THE WALL OF THE INFERIOR VENA CAVA.¿. (B)(6) 2018, PER A REPORT FROM COMPUTED TOMOGRAPHY; "THERE IS REDEMONSTRATION OF AN INFERIOR VENA CAVA FILTER LOCATED IN THE INFRARENAL IVC, UNCHANGED IN LONGITUDINAL POSITION, WITH MARKED INTERVAL INCREASE IN STRUT EXTENSION THROUGH THE IVC WALL, INCLUDING A RIGHT ANTERIOR STRUT EXTENDING APPROXIMATELY 2 CM TOWARD THE RIGHT LOWER QUADRANT, IN VICINITY OF MULTIPLE LOOPS OF SMALL BOWEL, A LEFT ANTERIOR STRUT APPEARING TO EXTEND THROUGH THE RIGHT INFRARENAL AORTIC WALL, AND A POSTERIORLY DIRECTED STRUT EXTENDING THROUGH THE SUPERIOR ENDPLATE· OF THE 13 VERTEBRAL BODY. NO EVIDENCE OF ACTIVE HEMORRHAGE OR HEMATOMA FORMATION". ¿IMPRESSION: 1. INTERVAL INCREASE IN EXTENSIO

    Patient problems: Internal Organ Perforation; Perforation of Vessels

    MAUDE report 16796169 ↗
  • InjuryJan 4, 2023Structural 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: Abdominal Pain; Chest Pain; Depression; Dyspnea; Insufficient Information; Perforation of Vessels

    MAUDE report 16094724 ↗
  • InjuryDec 7, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; Device Tipped Over; Unintended Movement; 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: Chest Pain; Dyspnea; Insufficient Information; Perforation of Vessels

    MAUDE report 15931606 ↗
  • InjuryNov 30, 2022Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Difficult to Remove; Obstruction of Flow; 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) 2013. APPROXIMATELY EIGHT YEARS LATER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN WHICH REVEALED SEVERAL IVC FILTER FRAGMENTS, AS WELL AS PROTRUSIONS OF THE FILTER INTO ABDOMINAL SPACES. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Device Embedded In Tissue or Plaque; Dyspnea; Foreign Body Embolism; Internal Organ Perforation; Pain; Perforation of Vessels; Peripheral Edema; Stenosis; Thrombosis/Thrombus

    MAUDE report 15885890 ↗
  • InjurySep 14, 2022Component Incompatible; Difficult or Delayed Activation; Component Incompatible; Difficult or Delayed Activation

    DESCRIPTION ACCORDING TO INITIAL REPORTER: DOCTOR WAS PLACED IVC FILTER WHEN THE FILTER DID NOT RELEASE FROM THE DELIVERY SYSTEM. WHEN DOCTOR WENT TO RETRACT THE DELIVERY SYSTEM, THE FILTER WAS STILL ATTACHED WITHOUT THE DOCTOR KNOWING AND THE FILTER PULLED INTO BACK TO ILIAC VEIN. THE DOCTOR PUT THE PATIENT TO SLEEP AND WHEN THEY PULLED HARD, THE FILTER DISENGAGED FROM DELIVERY SYSTEM. THE FILTER WAS LEFT IN PLACE AND A NEW FILTER WAS PLACED SUCCESSFULLY. IT WAS EXPLAINED TO THE REP. BY THE DOCTOR THAT THE FILTER LEFT IN PLACE WOULD POSE NO PROBLEMS TO THE PATIENT. THE PATIENT IS IN STABLE CONDITION. ADDITIONAL INFORMATION FROM (B)(4) MANUFACTURER REF. 3002808486-2022-00859: A COOK CELECT FILTER WAS THEN PLACED FOR OUR SHEATH. THE SHEATH WAS THEN BACKED UP TO UNCOVER THE FILTER, AND THE FILTER WAS DEPLOYED UNDER DIRECT FLOUROSCOPIC VISUALIZATION. HOWEVER, IT WOULD NOT RELEASE. ULTIMATELY THE FILTER WAS MOVED FROM THE IVC INTO THE RIGHT ILIAC VEIN, AND DUE TO THE MAL-DEPLOYMENT OF THE FILTER AND THE INABILITY FOR IT TO RELEASE FROM THE PUSH ROD OF THE COOK CELECT DELIVERY SYSTEM, THE DECISION WAS MADE TO LEAVE IT IN THE RIGHT ILIAC VEIN. IT SHOULD BE NOTED THAT PRIOR TO THIS THE PA

    Patient problems: Anxiety

    MAUDE report 15417603 ↗
  • InjurySep 12, 2022Obstruction of Flow; Structural Problem; Obstruction of Flow; Structural Problem

    THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014. APPROXIMATELY 3 YEARS AND 8 MONTHS LATER THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) OF THEIR ABDOMEN/PELVIS. THE CT SCAN INDICATED THAT THE FILTER PERFORATED 9MM THROUGH THE IVC WALL AND INTO THE ABDOMINAL AORTA. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

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

    MAUDE report 15401771 ↗
  • InjuryAug 24, 2022Structural Problem; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Structural Problem; Detachment of Device or Device Component; Unintended Movement; 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: Device Embedded In Tissue or Plaque; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 15284147 ↗
  • InjuryJun 28, 2022Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over; Difficult to Remove; Obstruction of Flow; Structural Problem; Device Tipped Over

    THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2010. THE PATIENT'S FILTER PERFORATED THROUGH THEIR IVC. ONE PRONG OF THE FILTER IS PERFORATING THE DUODENUM, AND A SECOND PRONG IS ABUTTING THE L3 VERTEBRAL BODY. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

    Patient problems: Anxiety; Device Embedded In Tissue or Plaque; Internal Organ Perforation; Obstruction/Occlusion; Perforation of Vessels; Stenosis; Thrombosis/Thrombus

    MAUDE report 14847465 ↗
  • InjuryJun 27, 2022Component Incompatible; Component Incompatible

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A COOK CELECT FILTER WAS THEN PLACED FOR OUR SHEATH. THE SHEATH WAS THEN BACKED UP TO UNCOVER THE FILTER, AND THE FILTER WAS DEPLOYED UNDER DIRECT FLOUROSCOPIC VISUALIZATION. HOWEVER,IT WOULD NOT RELEASE. ULTIMATELY THE FILTER WAS MOVED FROM THE IVC INTO THE RIGHT ILIAC VEIN, AND DUE TO THE MAL-DEPLOYMENT OF THE FILTER AND THE INABILITY FOR IT TO RELEASE FROM THE PUSH ROD OF THE COOK CELECT DELIVERY SYSTEM, THE DECISION WAS MADE TO LEAVE IT IN THE RIGHT ILIAC VEIN. IT SHOULD BE NOTED THAT PRIOR TO THIS THE PATIENT BECAME INCREASINGLY ANXIOUS AND UNCOMFORTABLE, AND DUE TO THE PATIENT'S MORBID OBESITY AND CONCERN FOR ADEQUATE AIRWAY CONTROL WITH INCREASING DOSES OF CONSCIOUS SEDATION, WE ELECTED TO CONVERT THE CASE TO GENERAL ENDOTRACHEAL ANESTHESIA, AND AS SUCH THE ANESTHESIA SERVICE INTUBATED THE PATIENT WHILE WE PAUSED TO GET THIS COMPLETED. ONCE THIS WAS DONE, WE RE-ENGAGED INTO THE PROCEDURE. THE SHEATH IN THE GROIN WAS USED TO HELP DISASSEMBLE THE PUSH SHAFT ASSEMBLY OF THE COOK CELECT DEVICE FROM THE ACTUAL IVC FILTER, WHICH WAS ULTIMATELY DEPLOYED IN THE DISTAL EXTERNAL ILIAC VEIN. THEREAFTER A WIRE WAS READVANCED UP INTO TH

    Patient problems: Anxiety

    MAUDE report 14828930 ↗
  • InjuryJun 23, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

    PATIENT ALLEGEDLY RECEIVED TWO IMPLANTS ON (B)(6) 2012 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS. THE PATIENT ALLEGES TILT AND VENA CAVA PERFORATION. THE PATIENT FURTHER ALLEGES FOUR PRONGS PERFORATED THE INFERIOR VENA CAVA (IVC), 5 DEGREE TILT RIGHT TO LEFT, AND 3 DEGREE TILT ANTERIOR POSTERIOR. (B)(6) 2017, PER A REPORT FROM COMPUTED TOMOGRAPHY; POSITIVE FOR CAVAL PERFORATION. SUPERIOR EXTENT OF FILTER IS AT THE SUPERIOR L2 VERTEBRAL BODY. INFERIOR EXTENT MID L3 VERTEBRAL BODY. FOUR PRONGS HAVE PERFORATED THE IVC. MAXIMUM DISTANCE PRONG PERFORATED IS 4MM. CORONAL IMAGES SHOW 5-DEGREE TILT RIGHT-TO-LEFT. SAGITTAL IMAGES SHOW 30DEGREE TILT ANTERIOR-POSTERIOR. DIAMETER OF IVC DIRECTLY ABOVE IS 19MM X 11MM.

    Patient problems: Perforation of Vessels

    MAUDE report 14795403 ↗
  • InjuryJun 14, 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) 2013, 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 14691315 ↗
  • InjuryJun 6, 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) 2012, 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 14603386 ↗
  • InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

    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; Depression; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 14444909 ↗
  • 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 FRACTURE. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels; Thromboembolism; Thrombosis/Thrombus; Unspecified Gastrointestinal Problem

    MAUDE report 14444823 ↗
  • 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 CELECT FILTER. PATIENT IS ALLEGING PERFORATION OF ORGAN. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Patient problems: Anxiety; Internal Organ Perforation; Obstruction/Occlusion; Perforation of Vessels; Stenosis

    MAUDE report 14444659 ↗
  • InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

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

    Patient problems: Internal Organ Perforation; Perforation of Vessels

    MAUDE report 14444561 ↗
  • InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

    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: Discomfort; Dyspnea; Numbness; Pain; Perforation; Perforation of Vessels

    MAUDE report 14444535 ↗
  • InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

    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

    MAUDE report 14444224 ↗
  • 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 14444210 ↗
  • InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

    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; Emotional Changes; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 14444198 ↗
  • InjuryMay 19, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Difficult to Remove; Structural Problem; Device Tipped Over; Detachment of Device or Device Component

    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; Foreign Body In Patient; Insufficient Information; Perforation of Vessels

    MAUDE report 14444166 ↗
  • 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: Anxiety; Internal Organ Perforation; Perforation of Vessels

    MAUDE report 14443868 ↗

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