Cook Celect G48372Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00827002483729), received between Feb 2, 2015 and Mar 13, 2024 — classified as 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (21 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2024Difficult to Remove; Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Difficult to Remove; Inadequate Filtration Process; Obstruction of Flow; Structural Problem

  PATIENT ALLEGEDLY RECEIVED A COOK CELECT FILTER ON (B)(6) 2010 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO BILATERAL ANKLE FRACTURES. PATIENT IS ALLEGING THE DEVICE IS UNABLE TO BE RETRIEVED, STRUTS OF IVC FILTER EXTEND BEYOND WALL OF IVC, AND, STRUT PASSES THROUGH ANTERIOR WALL OF DISTAL AORTA ABOVE THE LEVEL OF THE BIFURCATION. PATIENT NOTES AND FURTHER ALLEGES "I CONTINUE TO TAKE ELIQUIS FOR BLOOD CLOTS", "I NO LONGER ENGAGE IN STRENUOUS PHYSICAL ACTIVITY OR HEAVY LIFTING", "I DON'T HAVE A HISTORY OF BLOOD CLOTS PRIOR TO PLACEMENT OF THE IVC FILTER. I HAVE BEEN TREATED FOR BLOOD CLOTS IN MY LEGS AND LUNG", PER A COMPUTED TOMOGRAPHY (CT) REPORT: "IVC FILTER WITH MULTIPLE LEGS EXTENDING THROUGH THE WALL OF THE IVC, OF UNCERTAIN CLINICAL SIGNIFICANCE. NO PRIOR STUDIES AVAILABLE FOR COMPARISON". PER A CT REPORT: "IMPRESSION 1. EVALUATION OF SMALLER PULMONARY ARTERIES IS LIMITED BY MOTION, HOWEVER THERE IS A AREA OF HYPOATTENUATION IN THE LEFT LOWER LOBE ARTERY WHICH LIKELY REPRESENTS PULMONARY EMBOLUS. THERE ARE ADDITIONAL FILLING DEFECTS WHICH ARE FAVORED TO BE ARTIFACTUAL. NO EVIDENCE OF RIGHT HEART STRAIN. 2. LNFRARENAL IVC WITH EXTENSIVE THROMBUS EXTENDING FROM THE BILATERAL FEMO

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

  MAUDE report 18899907 ↗
• InjuryJun 28, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2012. APPROXIMATELY 9 YEARS AND 2 MONTHS LATER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN. THE SCAN DEMONSTRATED MULTIPLE STRUTS PERFORATING THROUGH THE CAVAL WALL. ONE STRUT ABUTS THE RIGHT PSOAS MUSCLE, AND ANOTHER APPEARS TO PERFORATE THE VERTEBRAL BODY CAUSING A BONY REACTION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

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

  MAUDE report 14848109 ↗
• InjuryJun 21, 2022Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; Structural Problem; Device Tipped Over

  THE FOLLOWING INFORMATION IS ALLEGED: THE PLAINTIFF RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2010. APPROXIMATELY ELEVEN YEARS LATER, A REVIEW OF THE PLAINTIFF'S COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE IVC FILTER WAS TILTED ANTERIORLY. THE FILTER STRUTS ALSO PERFORATED UP TO 18MM WITH A STRUT CONTACTING THE RIGHT HEPATIC LOBE AND TWO STRUTS THAT PERFORATED INTO THE SOFT TISSUES. THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2019 FROM CAUSES UNRELATED TO THE IVC FILTER. SPECIFIC DETAILS SURROUNDING THE PATIENT'S EXPIRATION ARE CURRENTLY UNKNOWN, AND THERE IS NO REPORTED ALLEGATION OF WRONGFUL DEATH AT THIS TIME. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Obstruction/Occlusion; Perforation of Vessels

  MAUDE report 14754521 ↗
• InjuryJun 20, 2022Inadequate 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) 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; Thrombosis/Thrombus

  MAUDE report 14743759 ↗
• 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) 2011, 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 14691309 ↗
• InjuryMay 19, 2022Inadequate Filtration Process; Inadequate Filtration Process

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

  Patient problems: Pulmonary Embolism

  MAUDE report 14444966 ↗
• 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 14444844 ↗
• InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  ADDITIONAL INFORMATION PROVIDED THE PATIENT ALLEGEDLY RECEIVED THE CELECT FILTER ON (B)(6) 2011.

  Patient problems: Anxiety; Depression; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14444759 ↗
• InjuryMay 19, 2022Difficult to Remove; Obstruction of Flow; Structural Problem; Detachment of Device or Device Component; Difficult to Remove; Obstruction of Flow; Structural Problem; 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; Obstruction/Occlusion; Perforation of Vessels; Stenosis; Thrombosis/Thrombus

  MAUDE report 14444677 ↗
• InjuryMay 19, 2022Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  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 14444663 ↗
• 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 14444506 ↗
• InjuryMay 19, 2022Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; 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: Anxiety; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 14444285 ↗
• 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: Anxiety; Perforation of Vessels

  MAUDE report 14444146 ↗
• 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 14444040 ↗
• InjuryMay 19, 2022Inadequate Filtration Process; Obstruction of Flow; Structural Problem; Device Tipped Over; Inadequate Filtration Process; 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; Perforation of Vessels; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 14443704 ↗
• InjuryApr 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) 2010, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Anxiety; Depression; Dyspnea; Insufficient Information; Internal Organ Perforation; Pain; Perforation of Vessels; Syncope/Fainting

  MAUDE report 14223743 ↗
• InjuryApr 27, 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) 2010. APPROXIMATELY 7 YEARS AND 7 MONTHS LATER THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE PATIENT'S ABDOMEN/PELVIS. THE CT SCAN REVEALED THAT THE TINES OF THE IVC FILTER HAD PERFORATED OUTSIDE THE WALL OF THE IVC AND THAT A STRUT WAS IN CONTACT WITH THE RIGHT POSTERIOR LATERAL WALL OF THE AORTA. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Perforation of Vessels; Stenosis; Thrombosis/Thrombus

  MAUDE report 14223168 ↗
• InjuryFeb 16, 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) 2011, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Dyspnea; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Internal Organ Perforation; Perforation of Vessels; Swelling/ Edema

  MAUDE report 13546482 ↗
• InjuryOct 29, 2021Device Tipped Over; Physical Resistance/Sticking; Device Tipped Over; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 12718188 ↗
• InjuryOct 7, 2021Structural Problem; Device Tipped Over; Structural Problem; Device Tipped Over

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2013 VIA THE RIGHT INTERNAL JUGULAR DUE TO PULMONARY EMBOLISM. PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, ORGAN PERFORATION. PATIENT FURTHER ALLEGES: FEAR, STRESS, ANXIETY AND LOSS OF ENJOYMENT OF LIFE, DEPRESSION. REPORT FROM COMPUTED TOMOGRAPHY (CT): "IVC FILTER: LOCATION OF THE IVC FILTER IS NORMALLY LOCATED WITHIN THE IVC WITH THE TIP 28 MM INFERIOR TO THE RENAL VEIN. ANGLE OF TILT: MILD POSTERIOR TILT IS NOTED. STRUTS: THE IVC FILTER STRUTS SHOW 4.3 MM OF EXTENSION THROUGH THE INFERIOR VENA CAVA WALL. THE MEDIAL LIMB CLOSELY ABUTS ADJACENT LATERAL WALL OF THE AORTA WITHOUT DEFINITE INTRALUMINAL EXTENSION. NO FRACTURE. RECOMMEND STRUTS ARE SEEN."

  Patient problems: Anxiety; Depression; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 12592100 ↗
• InjuryJun 9, 2021Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Structural Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO VENOUS THROMBOSIS/ PULMONARY EMBOLISM (PE). PATIENT IS ALLEGING VENA CAVA PERFORATION. PATIENT FURTHER ALLEGES "KEPT GETTING BLOOD CLOTS, SWOLLEN TO WHERE VEINS WOULD APPEAR AND PAIN SHARP AND UNBEARABLE, ALSO HAD TO LEARN HOW TO WALK AGAIN." "A LOT OF STANDING AND WALKING REQUIRES BREAKS IN-BETWEEN." "I HAD TO LEARN HOW TO WALK AGAIN, NEEDED HELP GETTING A BATH, AND FEEDING OR CHANGING." REPORTEDLY THE FILTER WAS REMOVED (B)(6) 2020.

  Patient problems: Insufficient Information; Pain; Perforation of Vessels; Thrombosis/Thrombus

  MAUDE report 11970495 ↗
• InjuryApr 30, 2021Obstruction of Flow; Obstruction of Flow

  NO ADDITIONAL EVENT INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11757329 ↗
• InjuryOct 4, 2019Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO INITIAL REPORTER: "A FRACTURE HAD OCCURRED AT AN UNKNOWN TIME AFTER FILTER PLACEMENT. FILTER PLACEMENT OCCURRED IN 2010. A SINGLE PRIMARY STRUT WAS FOUND FRACTURED. IT SAT PERFORATING THE IVC JUST BELOW THE MAIN BODY OF THE FILTER. PATIENT WAS ASYMPTOMATIC SO THE DECISION WAS MADE TO LEAVE THE FRACTURED STRUT AS TO NOT MAKE THE SITUATION WORSE. THE MAIN BODY OF THE FILTER WAS SUCCESSFULLY RETRIEVED." PER MEDWATCH REPORT - PT HAD IVC FILTER PLACED (B)(6) 2010. RECENT RADIOLOGY TESTS PERFORMED SHOWED IVC FILTER FRACTURE AND PERFORATION OF ONE STRUT INTO INFRARENAL AORTA. IVC FILTER WITH 3 REMAINING PRIMARY STRUTS INTACT AND 8 SECONDARY STRUTS INTACT REMOVED VIA INTERVENTIONAL RADIOLOGY PROCEDURE (B)(6) 2019. 1 STRUT RETAINED IN INFRARENAL AORTA (EXTRALUMINAL) DUE TO HIGH RISK OF HEMORRHAGE IF REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 9156771 ↗
• InjuryAug 22, 2018Fracture; Difficult to Remove; Fracture; Difficult to Remove

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2010 ((B)(4)) AND A CELECT FILTER ON (B)(6) 2010 ((B)(4))". ALLEGED: MIGRATION, TILT, VENA CAVA PERFORATION, FRACTURE, ORGAN PERFORATION, DEVICE IS UNABLE TO BE RETRIEVED PATIENT OUTCOME: PATIENT ALLEGES NECK PAIN, IMMOBILITY, DIZZINESS, ANXIETY, LACK OF SLEEP, PARANOIA, LOSS OF APPETITE AND SHORTNESS OF BREATH.

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

  MAUDE report 7804037 ↗
• MalfunctionOct 20, 2017Migration or Expulsion of Device; Difficult to Remove; Malposition of Device; Migration or Expulsion of Device; Difficult to Remove; Malposition of Device

  SUCCESSFUL RETRIEVAL OF FILTER PERFORMED (B)(6) 2018.

  Patient problems: Abdominal Pain; Anxiety

  MAUDE report 6964339 ↗