Cook Celect G52909Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10827002529097), received between Dec 23, 2014 and May 26, 2023 — classified as 3 deaths, 37 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (30 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

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Inadequate Filtration Process; Structural Problem; Appropriate Device Problem Term/Code Not Available; Inadequate Filtration Process; Structural Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2015 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING ORGAN AND VENA CAVA PERFORATION. PATIENT ALLEGES "ABDOMINAL AND BACK PAIN AS WELL AS SHORTNESS OF BREATH (SOB)", AND POST FILTER PLACEMENT PE. (B)(6) 2021: PER CT REPORT, "FILTER POSITION: BELOW THE RENAL VEINS." "FILTER PENETRATION: YES." "THE FILTER IS NOT TILTED BUT THE CONE OF THE FILTER IS AGAINST THE ANTERIOR WALL OF THE IVC. AXIAL IMAGE 109. THE ANTERIOR STRUT STRUT PENETRATES 15 MM THROUGH THE IVC WALL. SAGITTAL IMAGE 84. THE LEFT STRUT PENETRATES 16 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE LEFT COMMON ILIAC ARTERY. CORONAL IMAGE 41. THE POSTERIOR STRUT PENETRATES 9 MM THROUGH THE IVC WALL. IT PENETRATES INTO A VERTEBRA WHERE THERE ARE CHRONIC REACTIVE CHANGES. SAGITTAL IMAGE 83. THE RIGHT STRUT PENETRATES 0 MM THROUGH THE IVC WALL. CORONAL IMAGE 42."

  Patient problems: Abdominal Pain; Dyspnea; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels; Pulmonary Embolism

  MAUDE report 17009661 ↗
• InjuryApr 17, 2023Structural Problem; Detachment of Device or Device Component; Unintended Movement; Structural Problem; Detachment of Device or Device Component; Unintended Movement

  30OCT2021, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿THE ANTERIOR STRUT PENETRATES 22 MM THROUGH THE IVC WALL. IT PENETRATES ALL THE THROUGH THE DUODENUM. THE LEFT STRUT PENETRATES 21 MM THROUGH THE IVC WALL. THE POSTERIOR STRUT IS NOT SEEN. IT IS FRACTURED AND MIGRATED OFF OF THE FIELD OF VIEW. THE RIGHT STRUT PENETRATES 18 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE AORTA. A LEFT ARM STRUT PENETRATES 13 MM THROUGH THE IVC WALL. ONLY 7 FILTER ARMS ARE SEEN. THERE SHOULD BE 8 ARMS. ONE ARM IS MISSING WHICH REPRESENTS A FRACTURE WITH MIGRATION OF THE ARM OFF THE IMAGE SET. A POSTERIOR ARM STRUT PENETRATES 12 MM THROUGH THE IVC WALL.¿

  Patient problems: Abdominal Pain; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 16752029 ↗
• InjuryApr 17, 2023Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO PRE-BARIATRIC SURGERY. THE PATIENT ALLEGES VENA CAVA PERFORATION AND ORGAN PERFORATION. THE PATIENT FURTHER ALLEGES ABDOMINAL PAIN, AND STRESS. (B)(6) 2011, PER A REPORT FROM VENOGRAM; ¿LARGE THROMBUS FOUND. IVC WAS NOT REMOVED.¿ (B)(6), PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿THE DEGREE OF TILT: 15 DEGREES OF RIGHTWARD TILT. THE APEX OF THE FILTER IS TOUCHING THE RIGHT SIDE OF THE IVC WALL. FILTER POSITION: NORMAL. APEX IS 6 MM BELOW THE RIGHT RENAL VEIN ORIFICE. THE STRUTS ARE ABOVE THE AORTIC BIFURCATION. STRUT PERFORATION: THE LEFT ANTEROLATERAL STRUT EXTENDS 4 MM BEYOND THE IVC WALL AND ABUTS THE AORTA. THE RIGHT ANTERIOR STRUT EXTENDS 4 MM BEYOND THE IVC WALL. STRUT FRACTURE OR BENDING: NONE. IVC STENOSIS: NONE.¿

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

  MAUDE report 16751421 ↗
• InjuryJan 18, 2023Obstruction of Flow; Structural Problem; Obstruction of Flow; Structural Problem

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2013. THE PATIENT WAS DIAGNOSED WITH A PERFORATION OF THE IVC ON (B)(6) 2019. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 16194342 ↗
• InjuryJan 18, 2023Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT INTERNAL JUGULAR VEIN AS A PRECAUTION PRIOR TO SURGERY. PATIENT IS ALLEGING FRACTURE, ORGAN AND VENA CAVA PERFORATION, AND TILT. PATIENT ALLEGES "PERFORATION INTO THE ABDOMINAL AORTA, DUODENUM, AND INTO L2 VERTEBRAL BODY RIGHT SIDE; 19.51 DEGREE CORONAL TILT AND 6.22 DEGREE SAGITTAL TILT; FRACTURE OF 6 O'CLOCK ARM; POSSIBLE MIGRATION. TILT IS AT LEVEL OF LEFT RENAL VEIN CONFLUENCE." PER COMPUTED TOMOGRAPHY REPORT, "CAVAL PERFORATION: YES. GRADE 4 PERFORATION OF 3 O'CLOCK LEG INTO THE ABDOMINAL AORTA. GRADE 4 PENETRATION OF 6 O'CLOCK LEG INTO L2 VERTEBRAL BODY RIGHT SIDE. GRADE 4 PERFORATION OF 3 O'CLOCK LEG INTO DUODENUM AND GRADE 4 PERFORATION OF 12 O'CLOCK LEFT INTO DUODENUM." TILT: YES. 19.51 DEGREE CORONAL TILT AND 6.22 DEGREE SAGITTAL TILT." "MIGRATION. POSSIBLE. TILT IS AT LEVEL OF LEFT RENAL VEIN CONFLUENCE." "FRACTURE OF 6 O'CLOCK ARM."

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

  MAUDE report 16194071 ↗
• InjurySep 12, 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 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; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels

  MAUDE report 15401781 ↗
• InjuryJun 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 CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014, 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; Internal Organ Perforation; Pain; Perforation of Vessels; Stenosis; Thrombosis/Thrombus

  MAUDE report 14848138 ↗
• 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 14444910 ↗
• 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 14444756 ↗
• 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: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14444692 ↗
• 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 14444558 ↗
• InjuryMay 19, 2022Detachment of Device or Device Component; 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: Insufficient Information

  MAUDE report 14444466 ↗
• 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 14444260 ↗
• 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 14444194 ↗
• 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 14444187 ↗
• InjuryMay 19, 2022Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

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

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

  MAUDE report 14443608 ↗
• InjuryMar 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 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 13840748 ↗
• MalfunctionMar 14, 2022Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER DID NOT DEPLOY. NEW FILTER FROM SAME LOT WAS USED WITHOUT ISSUES. PROCEDURE COMPLETED IN LESS THAN 30 MINUTES. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13756891 ↗
• InjuryFeb 25, 2022Inadequate Filtration Process; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Inadequate Filtration Process; 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) 2014, 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; Pulmonary Embolism

  MAUDE report 13604282 ↗
• InjuryFeb 17, 2022Difficult to Remove; Structural Problem; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Structural Problem; 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) 2010, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

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

  MAUDE report 13554243 ↗
• InjuryFeb 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 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: Anxiety; Depression; Device Embedded In Tissue or Plaque; Insufficient Information; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 13502647 ↗
• InjuryJan 19, 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

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 DUE TO BLOOD CLOTS. PATIENT IS ALLEGING TILT AND VENA CAVA/ORGAN PERFORATION, AND DEVICE IS UNABLE TO BE RETRIEVED. THE PATIENT FURTHER ALLEGES PAIN, DISCOMFORT, ANXIETY, AND LIMITED PHYSICAL ACTIVITY.

  Patient problems: Anxiety; Discomfort; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels

  MAUDE report 13292344 ↗
• InjuryDec 1, 2021Structural 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) 2010, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Anxiety; Emotional Changes; Insufficient Information; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 12910095 ↗
• InjuryOct 21, 2021Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available

  PER COMPUTED TOMOGRAPHY REPORT, "FILTER CONE POSITION: BELOW THE RENAL VEINS." "FILTER PENETRATION: YES." "THE ANTERIOR RIGHT SIDE FILTER LEG PERFORATES 18 MM THROUGH THE IVC WALL..." "THE POSTERIOR LEFT SIDE FILTER LEG PERFORATES 13MM THROUGH THE IVC WALL..." "THE ANTERIOR LEFT SIDE FILTER LEG PERFORATES 19 MM THROUGH THE IVC WALL AND ITS TIP PENETRATES THE AORTA...".

  Patient problems: Insufficient Information; Perforation of Vessels

  MAUDE report 12674876 ↗
• InjurySep 13, 2021Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Inadequate Filtration Process; Obstruction of Flow; 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) 2011, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

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

  MAUDE report 12462489 ↗