Cook Celect G48378Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00827002483781), received between May 1, 2015 and Aug 24, 2023 — classified as 23 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (16 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

  THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011 VIA RIGHT COMMON FEMORAL DUE TO DEEP VEIN THROMBOSIS (DVT)AND PULMONARY EMBOLISM (PE). THE PATIENT IS ALLEGING VENA CAVA PERFORATION. THE PATIENT FURTHER ALLEGES THAT PATIENT EXPERIENCE STOMACH PAIN.

  Patient problems: Abdominal Pain; Insufficient Information; Perforation of Vessels

  MAUDE report 17610988 ↗
• InjuryFeb 27, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

  (B)(6) 2020, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿IVC FILTER WITH ONE LEG EXTENDING THROUGH THE WALLS OF THE IVC AND INTO THE WALL OF THE THIRD PART OF THE DUODENUM. NO ASSOCIATED PATHOLOGY IS APPARENT".

  Patient problems: Ambulation or Postural Difficulties; Chest Pain; Dyspnea; Insufficient Information; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 16443151 ↗
• InjuryJun 7, 2022Unintended Movement; Appropriate Device Problem Term/Code Not Available; 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) 2014, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Anxiety; Depression; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pain

  MAUDE report 14623029 ↗
• 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) 2010, 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 14605202 ↗
• 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 14444832 ↗
• 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 14444824 ↗
• 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 14444389 ↗
• 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 14443462 ↗
• InjuryMay 19, 2022Structural Problem; Device Tipped Over; Unintended Movement; Structural Problem; Device Tipped Over; Unintended Movement

  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 14443390 ↗
• InjuryMay 19, 2022Structural Problem; Unintended Movement; Structural Problem; 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; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14443388 ↗
• InjuryApr 13, 2022Structural Problem; Structural Problem

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2011. MULTIPLE PRONGS OF THE FILTER HAVE PERFORATED PATIENT'S INFERIOR VENA CAVA. ONE PRONG OF THE FILTER IS ABUTTING THE PERIOSTEUM OF PATIENT L3 VERTEBRAL BODY. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Anxiety; Perforation of Vessels

  MAUDE report 14091690 ↗
• InjuryApr 13, 2021Structural Problem; Detachment of Device or Device Component; Structural Problem; Detachment of Device or Device Component

  IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2010 VIA THE RIGHT FEMORAL APPROACH; FOLLOWED BY A SUCCESSFUL PERCUTANEOUS REMOVAL (B)(6) 2018. THE PATIENT ALLEGES VENA CAVA (VC) PERFORATION, FRACTURE, FRAGMENTS REMAIN AND EXTEND INTO L3 VERTEBRAL BODY AND RIGHT OF THE PSOAS MUSCLE. PATIENT FURTHER ALLEGES DIFFICULTY PERFORMING STRAINING TASKS; SHORTNESS OF BREATH; PAIN, EXTREMELY DEPRESSED, AND CONSTANT FEELING OF HOPELESSNESS. PER THE RETRIEVAL REPORT (SUCCESSFUL): "IVC FILTER RETRIEVAL." "FRACTURE FILTER." "INITIAL SCOUT RADIOGRAPHS DEMONSTRATED A FRACTURED INFERIOR VENA CAVA FILTER. 1 LEG PROJECTS OVER THE RIGHT LOWER QUADRANT. 2 LEGS PROJECTS ABOVE THE MAIN BODY OF THE FILTER SEPARATE FROM THE MAIN BODY. ANOTHER LEG IS FRACTURED WITH HALF STILL ATTACHED TO THE FILTER AND THE OTHER HALF EMBEDDED IN THE L3 VERTEBRAL BODY." "SUCCESSFUL ENDOVASCULAR RETRIEVAL OF ALL INTRAVASCULAR INFERIOR VENA CAVA FILTER COMPONENTS." PER THE REPORT FROM COMPUTERIZED TOMOGRAPHY (CT): "FRAGMENTS OF THE FILTER REMAINS AT THE ANTERIOR ASPECT OF THE IVC ON SERIES 2 IMAGE 42, EXTENDING INTO THE L3 VERTEBRAL BODY ON SERIES 2 IMAGE 49 AND IS 4 IMAGE 74 AND POSTE

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

  MAUDE report 11655665 ↗
• InjuryNov 12, 2020Inadequate Filtration Process; Structural Problem; Detachment of Device or Device Component; Insufficient Device Problem Information; Inadequate Filtration Process; Structural Problem; Detachment of Device or Device Component; Insufficient Device Problem Information

  NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Internal Organ Perforation; No Information; Perforation of Vessels; Pulmonary Embolism

  MAUDE report 10827418 ↗
• InjurySep 24, 2020Structural Problem; Device Tipped Over; Unintended Movement; Structural Problem; Device Tipped Over; Unintended Movement

  PER REPORT FROM CT: "FINDINGS: AN IVC FILTER IS SEEN. THE SUPERIOR 1/3 OF THE FILTER IS WITHIN THE INTRAHEPATIC PORTION OF THE IVC. THE APEX OF THE FILTER CONTACTS THE ANTERIOR WALL OF THE INTRAHEPATIC IVC. THE LONG AXIS OF THE FILTER RELATIVE TO THE VERTICAL ANTERIOR WALL MEASURES APPROXIMATELY 32°, THE POSTERIOR STRUTS OF THE IVC FILTER APPEARS TO PERFORATE THE IVC WALL. AT 7:00 POSITION, THE STRUT TIP MEASURES 5 MM FROM THE POSTERIOR IVC WALL. AT 4:00 POSITION, THE STRUT MEASURES APPROXIMATELY 5 MM FROM THE POSTERIOR IVC WALL AND CONTACTS THE JUNCTION OF THE RIGHT RENAL VEIN AND AORTA. THERE IS NO STRUT FRACTURE OR BENDING. NO STENOSIS OF THE IVC IS SEEN."

  Patient problems: Anxiety; Great Vessel Perforation; Internal Organ Perforation; Vessel Or Plaque, Device Embedded In

  MAUDE report 10579815 ↗
• InjuryJun 23, 2020Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Great Vessel Perforation; Internal Organ Perforation

  MAUDE report 10183296 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT [PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2012. PATIENT OUTCOME: IT IS ALLEGED THAT THE [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: No Information; Perforation of Vessels; Thrombosis; Vessel Or Plaque, Device Embedded In

  MAUDE report 9472021 ↗
• InjuryDec 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2012. IT IS ALLEGED THAT THE [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED."

  Patient problems: No Information

  MAUDE report 9445736 ↗
• InjuryDec 9, 2019Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO CATEGORIZATION FORM AND PPS: 'IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2013" IT IS ALSO ALLEGED "TILT", "VENA CAVA PERFORATION" & "ORGAN PERFORATION". [PT] ALLEGES: "PERFORATION - THE FILTER IS TILTED ANTERIORLY AND MEDIALLY AND THE HOOK DOES NOT CONTACT THE IVC WALL. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 12MM. ONE ANTERIOR STRUT PERFORATES THE IVC WALL 12MM AND CONTACTS THE BOWEL. ONE MEDIAL STRUT PERFORATES THE IVC WALL 5MM AND CONTACTS THE AORTA. ONE MEDIAL STRUT PERFORATES THE IVC WALL 5MM AND RESIDES WITHIN THE SOFT TISSUES. ONE POSTERIOR STRUT PERFORATES 8MM AND RESIDES WITHIN THE SOFT TISSUES. ONE LATERAL STRUT PERFORATES THE IVC WALL 7MM AND RESIDES WITHIN THE SOFT TISSUES. TWO LATERAL STRUTS PERFORATE THE IVC WALL 5MM AND 10MM AND CONTACT THE BOWEL". PATIENT OUTCOME: [PT] ALLEGES "I HAVE SHORTNESS OF BREATH AND I AM UNABLE TO WALK LONG DISTANCES DUE TO MY LEGS SWELLING. MY RIGHT THIGH IS SWOLLEN AND THE VEIN IS INFECTED WHERE THE IVC FILTER WAS IMPLANTED. REGULAR EXERCISE IS STRENUOUS TO ME NOW. LOTS OF PAIN IN MY LEFT THIGH". NUMBER OF DVT AFTER IMPLANT: "UNKNOWN".

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

  MAUDE report 9436738 ↗
• InjuryDec 3, 2019Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available

  'IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2013". IT IS ALSO ALLEGED "TILT", "VENA CAVA PERFORATION" & "ORGAN PERFORATION". [PT] ALLEGES "I HAVE SHORTNESS OF BREATH AND I AM UNABLE TO WALK LONG DISTANCES DUE TO MY LEGS SWELLING. MY RIGHT THIGH IS SWOLLEN AND THE VEIN IS INFECTED WHERE THE IVC FILTER WAS IMPLANTED. REGULAR EXERCISE IS STRENUOUS TO ME NOW. LOTS OF PAIN IN MY LEFT THIGH". [PT] ALLEGES: "PERFORATION: THE FILTER IS TILTED ANTERIORLY AND MEDIALLY AND THE HOOK DOES NOT CONTACT THE IVC WALL. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 12MM. ONE ANTERIOR STRUT PERFORATES THE IVC WALL 12MM AND CONTACTS THE BOWEL. ONE MEDIAL STRUT PERFORATES THE IVC WALL 5MM AND CONTACTS THE AORTA. ONE MEDIAL STRUT PERFORATES THE IVC WALL 5MM AND RESIDES WITHIN THE SOFT TISSUES. ONE POSTERIOR STRUT PERFORATES 8MM AND RESIDES WITHIN THE SOFT TISSUES. ONE LATERAL STRUT PERFORATES THE IVC WALL 7MM AND RESIDES WITHIN THE SOFT TISSUES. TWO LATERAL STRUTS PERFORATE THE IVC WALL 5MM AND 10MM AND CONTACT THE BOWEL".

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

  MAUDE report 9402295 ↗
• InjuryMar 20, 2018Fracture; Migration or Expulsion of Device; Difficult to Remove; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Fracture; Migration or Expulsion of Device; Difficult to Remove; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2010". PATIENT OUTCOME: "[PT] ALLEGES MIGRATION, TILT, VENA CAVA PERFORATION, FRACTURE, DEVICE IS UNABLE TO BE RETRIEVED AND SUBSEQUENT PE AND DTV"

  Patient problems: Perforation of Vessels; Pulmonary Embolism; Thrombosis

  MAUDE report 7351848 ↗
• InjuryOct 19, 2017Entrapment of Device; Migration or Expulsion of Device; Structural Problem; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Migration or Expulsion of Device; Structural Problem; Appropriate Device Problem Term/Code Not Available

  PER CT REPORT, (B)(6) 2017, IVC FILTER NOTED. TILTING OF THE APEX OF THE EMBEDMENT OF THE APEX FILTER INTO THE IVC WALL. THERE IS APPROXIMATELY 13 DEGREE TILT. THERE IS ALSO PERFORATION OF THE PRIMARY STRUTS INTO THE MESENTERY.

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

  MAUDE report 6961243 ↗
• MalfunctionOct 2, 2017Migration or Expulsion of Device; Difficult to Remove; Malposition of Device; Migration or Expulsion of Device; Difficult to Remove; Malposition of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER ON (B)(6) 2015". ADDITIONAL INFORMATION RECEIVED 14SEP2017: PATIENT RECEIVED AN IMPLANT ON (B)(6) 2015 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO MOTOR VEHICLE ACCIDENT, PULMONARY EMBOLISM. PATIENT OUTCOME: PATIENT EXPERIENCES DEVICE UNABLE TO BE RETRIEVED, TILT; PATIENT IS ALLEGING MIGRATION, ANXIETY. RETRIEVAL WAS ATTEMPTED ON (B)(6) 2015.

  Patient problems: Anxiety

  MAUDE report 6907200 ↗
• MalfunctionMay 24, 2017Difficult to Remove; Unintended Movement; Insufficient Device Problem Information; Difficult to Remove; Unintended Movement; Insufficient Device Problem Information

  DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER IN (B)(6) 2012." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: No Information

  MAUDE report 6590010 ↗
• InjuryMar 23, 2017Migration or Expulsion of Device; Difficult to Remove; Structural Problem; Unintended Movement; Insufficient Device Problem Information; Migration or Expulsion of Device; Difficult to Remove; Structural Problem; Unintended Movement; Insufficient Device Problem Information

  DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A CELECT FILTER ON (B)(6) 2013." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: Abdominal Pain; Device Embedded In Tissue or Plaque; Internal Organ Perforation; No Information; Numbness; Perforation

  MAUDE report 6427095 ↗
• MalfunctionMar 8, 2017Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A CELECT FILTER PLACED 2 YEARS PRIOR WAS TILTED AND PERFORATING THE IVC. IN THE IMAGES YOU CAN SEE THE SECONDARY LEGS LOOK ODD AND ONCE IT WAS REMOVED ONE OF THE SECONDARY LEG WAS WRAPPED AROUND PRIMARY LEG. THE FILTER CAME OUT SMOOTH WITH NO HARM TO THE PATIENT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Perforation of Vessels

  MAUDE report 6386528 ↗