Cook Celect G34502Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 10827002345024), received between Apr 28, 2015 and Feb 12, 2025 — classified as 2 deaths, 97 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (37 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 14, 2022Terminated

   IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

   Z-0876-2022 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Premature Activation; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362586 ↗
• MalfunctionOct 25, 2024Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON INSERTING THE FILTER INTO THE SHEATH, THE PHYSICIAN DID NOT INITIALLY FEEL RESISTANCE, BUT THEN FELT A GREAT DEAL OF RESISTANCE AND THEN NO AGAIN NO RESISTANCE. THE PHYSICIAN KNEW THAT SOMETHING MUST HAVE OCCURRED SO THE ENTIRE SYSTEM WAS REMOVED AS A WHOLE. THE TINES OF THE FILTER BECAME CAUGHT AT THE ACCESS SITE. PHYSICIAN PERFORMED A SMALL CUT DOWN TO REMOVE THE DEVICE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531725 ↗
• InjuryJan 30, 2024Improper or Incorrect Procedure or Method; Sharp Edges; Improper or Incorrect Procedure or Method; Sharp Edges

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

  Patient problems: Perforation of Vessels

  MAUDE report 18605076 ↗
• InjuryOct 20, 2023Obstruction of Flow; Structural Problem; Device Tipped Over; Obstruction of Flow; Structural Problem; Device Tipped Over

  IT IS ALLEGED THAT THE PATIENT RECEIVED A GUNTHER TULIP INFERIOR VENA CAVA FILTER (IVC) ON (B)(6) 2014 DUE TO DEEP VEIN THROMBOSIS (DVT). APPROXIMATELY 7 YEARS AND 4 MONTHS LATER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN (¿CT SCAN¿) REVIEW WHICH SHOWED MULTIPLE LEGS OF THE FILTER PERFORATING THROUGH THE IVC AND PERFORATING INTO THE AORTA. THE FILTER PERFORATED 3 MM THROUGH THE INFERIOR VENA CAVA, CAUSING ABDOMINAL PAIN. PATIENT HAS ALSO EXPERIENCED PAIN AND DISTRESS RESTRICTING THEIR ABILITY TO ENGAGE IN ACTIVITIES OF DAILY LIVING. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

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

  MAUDE report 17974770 ↗
• InjuryAug 28, 2023Structural Problem; Structural Problem

  PATIENT ALLEGEDLY RECEIVED A CELECT PLATINUM (PT) INFERIOR VENA CAVA (IVC) FILTER ON (B)(6)2016 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO POST DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). THE PATIENT ALLEGES VENA CAVA PERFORATION AND ORGAN PERFORATION. THE PATIENT FURTHER ALLEGES ABDOMINAL PAIN. (B)(6) 2021, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿THE FILTER IS NOT TILTED BUT THE CONE OF THE FILTER IS AGAINST THE RIGHT WALL OF THE IVC. THE ANTERIOR STRUT PENETRATES 10 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM. THE LEFT STRUT PENETRATES 12 MM THROUGH THE IVC WALL. THE POSTERIOR STRUT PENETRATES 10 MM THROUGH THE IVC WALL. THE RIGHT STRUT PENETRATES 11 MM THROUGH THE IVC WALL. IT PENETRATES INTO THE DUODENUM.¿

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

  MAUDE report 17637416 ↗
• InjuryJul 27, 2023Structural 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

  PER A REPORT FROM COMPUTED TOMOGRAPHY (CT),"IVC STENOSIS: NO. FILTER POSITION: BELOW THE RENAL VEINS. FILTER MIGRATION: NONE. FILTER FRACTURE/BENDING: YES. FILTER TILT: YES. FILTER PENETRATION: YES. OTHER FINDINGS: YES. IMPRESSIONS: ONLY 6 FILTER ARMS ARE SEEN. THERE SHOULD BE 8 ARMS. TWO ARMS ARE MISSING WHICH REPRESENTS A FRACTURE WITH MIGRATION OF THE ARM OFF THE IMAGE SET. ALSO ONE OF THE REMAINING ARMS IS BENT 90 DEGREES FROM ITS NORMAL POSITION. THIS ARM PENETRATES 14 MM THROUGH THE IVC WALL. CORONAL IMAGE 62. THE FILTER IS TILTED TO THE LEFT WITH ITS PROXIMAL CONE 11 MM THROUGH THE IVC WALL. CORONAL IMAGE 61. THE ANTERIOR RIGHT STRUT PENETRATES 8 MM THROUGH THE IVC WALL. CORONAL IMAGE 62. THE ANTERIOR LEFT STRUT PENETRATES 100 MM THROUGH THE IVC WALL. CORONAL IMAGE 63. THE POSTERIOR RIGHT STRUT PENETRATES 6 MM THROUGH THE IVC WALL. CORONAL IMAGE 67. THE POSTERIOR LEFT STRUT PENETRATES 0 MM THROUGH THE IVC WALL, SAGITTAL IMAGE 45."

  Patient problems: Perforation of Vessels

  MAUDE report 17409722 ↗
• InjuryJul 24, 2023Unintended Movement; Unintended Movement

  ACCORDING TO THE INITIAL REPORTER, UPON INSERTION OF THE FILTER, THE FILTER DETACHED FROM THE CATHETER BUT WOULD NOT OPEN. IT WAS RETRIEVED SUCCESSFULLY WITH A CLOVER SNARE. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH AN IJ FILTER OF THE SAME TYPE. THE DOCTOR SPECULATED THAT THE FILTER WOULD NOT OPEN BECAUSE OF PLAQUE OR BEING INSIDE A DISSECTION PLANE. HE DOES NOT THINK THAT THE DEVICE MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376293 ↗
• InjuryJul 18, 2023Improper or Incorrect Procedure or Method; Unintended Movement; Improper or Incorrect Procedure or Method; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340895 ↗
• InjuryJul 17, 2023Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Structural Problem; Device Tipped Over; Appropriate Device Problem Term/Code Not Available

  THE PATIENT RECEIVED THE FILTER DUE TO DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE). THE PATIENT IS ALLEGING VENA CAVA PERFORATION, AND TILT. THE PATIENT FURTHER ALLEGES FEAR THAT FILTER MIGHT CAUSE FURTHER DAMAGE AS IT HAS NOT YET BEEN REMOVED. PER A CT OF ABDOMEN AND PELVIS: "VASCULATURE: LNFRARENAL IVC FILTER IS PRESENT WITH MINIMAL IF ANY RIGHTWARD ANGULATION. THE DISTAL ASPECTS OF THE LONGEST STRUTS DEMONSTRATE MINIMAL PENETRATION BEYOND THE WALL OF IVC, UP TO 3 MM. THERE MAY BE MINIMAL PENETRATION INTO THE RIGHT PSOAS MUSCLE FROM THE POSTERIOR STRUT. THERE IS NO EVIDENCE OF A BREAK. THE UPPER ASPECT OF THE FILTER IS APPROXIMATELY 6 MM FROM THE RIGHT RENAL VEIN".

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

  MAUDE report 17331926 ↗
• MalfunctionJun 23, 2023Failure to Advance; Difficult or Delayed Activation; Failure to Advance; Difficult or Delayed Activation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189377 ↗
• MalfunctionJun 23, 2023Failure to Advance; Difficult or Delayed Activation; Failure to Advance; Difficult or Delayed Activation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189321 ↗
• InjuryJun 6, 2023Difficult to Remove; Structural Problem; Device Tipped Over; Difficult to Remove; Structural Problem; Device Tipped Over

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2018. APPROXIMATELY 3 YEARS LATER THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY SCAN ("CT SCAN") OF THE ABDOMEN, WHICH SHOWED THE FILTER TILTED WITH APEX AGAINST THE CAVAL WALL. MULTIPLE STRUTS PERFORATE THE IVC, ONE OF WHICH IS CONTACTING THE VERTEBRAL BODY AND CAUSING A BONY REACTION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Depression; Device Embedded In Tissue or Plaque; Pain; Perforation of Vessels; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 17071116 ↗
• InjuryApr 25, 2023Device Tipped Over; Device Tipped Over

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805234 ↗
• InjuryApr 24, 2023Structural 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)2017, AND THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

  Patient problems: Anxiety; Insufficient Information; Perforation of Vessels

  MAUDE report 16796382 ↗
• InjuryApr 18, 2023Device Tipped Over; Device Tipped Over

  ACCORDING TO THE INITIAL REPORTER, G34502 E4355500 (SUBJECT OF THIS REPORT) WAS DEPLOYED TILTED SO FILTER WAS RETRIEVED AND A NEW FILTER WAS PLACED. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761208 ↗
• InjuryApr 12, 2023Improper or Incorrect Procedure or Method; Device Tipped Over; Improper or Incorrect Procedure or Method; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHEN THE PHYSICIANS WENT TO DEPLOY THE FILTER, THE RESIDENT THAT WAS DOING IT INSTEAD OF PIN AND PULLING, PUSHED THE DEVICE FORWARD AND THEN PULLED IT BACK WHICH CAUSED THE SECONDARY STRUCTURE OF THE FILTER TO ENGAGE AND EXPAND WHEN THEY RELEASED THE FILTER. IT CAUSED THE FILTER TO TILT SIGNIFICANTLY. THEN PHYSICIANS HAD TO GO IN AND RETRIEVE THE FILTER AND USE A FILTER FROM ANOTHER MANUFACTURER. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723354 ↗
• InjuryApr 10, 2023Device Tipped Over; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN WAS UNHAPPY WITH THE ANGLE THAT FILTER WAS DEPLOYED AND CHOSE TO RETRIEVE THE FILTER. HE PLACED A NEW FILTER VIA FEMORAL. NO HARM TO PATIENT. ADDITIONAL INFORMATION RECEIVED ON 17MAR2023: FILTER WAS RETRIEVED RIGHT AWAY IMPLANTED AND RETRIEVED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708822 ↗
• InjuryMar 30, 2023Improper or Incorrect Procedure or Method; Device Tipped Over; Improper or Incorrect Procedure or Method; Device Tipped Over

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16641256 ↗
• InjuryMar 23, 2023Improper or Incorrect Procedure or Method; Device Tipped Over; Improper or Incorrect Procedure or Method; Device Tipped Over

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596348 ↗
• InjuryMar 22, 2023Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

  15MAR2021, PER A REPORT FROM COMPUTED TOMOGRAPHY 2; "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: NO. IMPRESSIONS: THE FILTER IS NOT TILTED BUT THE CONE OF THE FILTER IS AGAINST THE POSTERIOR WALL OF THE IVC. THE ANTERIOR STRUT PENETRATES 1.4 MM THROUGH THE IVC WALL. THE LEFT STRUT PENETRATES 1.9 MM THROUGH THE IVC WALL. THE POSTERIOR STRUT PENETRATES 6 MM THROUGH THE IVC WALL. THE RIGHT STRUT PENETRATES 5 MM THROUGH THE IVC WALL.¿

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

  MAUDE report 16591335 ↗
• InjuryMar 9, 2023Difficult to Insert; Difficult to Insert

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN STATED THAT THE FILTER JUMPED OUT OF THE SHEATH. THE PHYSICIAN DID NOT FEEL THE TACTILE BUMP ON THE DELIVERY SYSTEM THAT SHOULD HAVE ALERTED HIM TO PAUSE THE ADVANCEMENT. THE PHYSICIAN TRIED TO RE-SHEATH THE FILTER. THE SECONDARY LEGS WERE BENT POINTING TOWARD THE PATIENT'S HEAD. THE FILTER HAD NOT BEEN RELEASED FROM THE DELIVERY SYSTEM BUT COULD NOT BE RE-SHEATHED. THEY TRIED TO RETRIEVE IT BUT COULD NOT GET THE CLOVER SNARE TO CAPTURE THE HOOK. THE PHYSICIAN USED GRASPER FORCEPS TO GRASP THE FILTER AND ADVANCE A 16 FR SHEATH OVER THE FILTER TO RETRIEVE IT. AS THE SHEATH COVERED THE SECONDARY LEGS, THE GRASPER RELEASED THE FILTER AND THE SHEATH CAME OFF. THE LEGS THEN STRAIGHTENED OUT TO THE NORMAL POSITION. THE PHYSICIAN PROCEEDED TO DEPLOY THE FILTER SUCCESSFULLY. THIS PROBLEM DID EXTEND THE TIME REQUIRED TO COMPLETE THE PROCEDURE TO AROUND 4 HOURS. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511083 ↗
• InjuryMar 7, 2023Difficult to Insert; Difficult to Insert

  ACCORDING TO THE INITIAL REPORTER, THE DOCTOR STATED THAT THE FILTER JUMPED OUT OF THE SHEATH. THE DOCTOR DID NOT FEEL THE TACTILE BUMP ON THE DELIVERY SYSTEM THAT SHOULD HAVE ALERTED HIM TO PAUSE THE ADVANCEMENT. THE DOCTOR TRIED TO RE-SHEATH THE FILTER. THE SECONDARY LEGS WERE BENT POINTING TOWARD THE PATIENT'S HEAD. THE FILTER HAD NOT BEEN RELEASED FROM THE DELIVERY SYSTEM BUT COULD NOT BE RE-SHEATHED. THEY TRIED TO RETRIEVE IT BUT COULD NOT GET THE CLOVER SNARE TO CAPTURE THE HOOK. THE DOCTOR USED GRASPER FORCEPS TO GRASP THE FILTER AND ADVANCE A 16 FR SHEATH OVER THE FILTER TO RETRIEVE IT. AS THE SHEATH COVERED THE SECONDARY LEGS, THE GRASPER RELEASED THE FILTER AND THE SHEATH CAME OFF. THE LEGS THEN STRAIGHTENED OUT TO THE NORMAL POSITION. THE DOCTOR PROCEEDED TO DEPLOY THE FILTER SUCCESSFULLY. THIS PROBLEM DID EXTEND THE TIME REQUIRED TO COMPLETE THE PROCEDURE TO AROUND 4 HOURS. THE REP WAS CALLED IN AFTER THE INITIAL DEPLOYMENT ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494733 ↗
• InjuryFeb 23, 2023Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET, G34502, WAS USED. WHEN THE PHYSICIAN DEPLOYED THE FILTER THE SECONDARY STRUTS DID NOT OPEN PROPERLY. THE STRUTS BENT BACKWARDS. FILTER WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A COMPETITORS DEVICE. FILTER WAS DEPLOYED BELOW THE LOWEST RENAL LIKE INTENDED, ACCESS THROUGH FEM. FILTER WAS PLACED AND IMMEDIATE RETRIEVAL FOLLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16426133 ↗
• InjuryFeb 20, 2023Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET, G34502, WAS USED. WHEN THE PHYSICIAN DEPLOYED THE FILTER THE SECONDARY STRUTS DID NOT OPEN PROPERLY. THE STRUTS BENT BACKWARDS. FILTER WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A COMPETITORS DEVICE. FILTER WAS DEPLOYED BELOW THE LOWEST RENAL LIKE INTENDED, ACCESS THROUGH FEM. FILTER WAS PLACED AND IMMEDIATE RETRIEVAL FOLLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402095 ↗
• InjuryOct 18, 2022Difficult to Remove; Obstruction of Flow; Structural Problem; Difficult to Remove; Obstruction of Flow; Structural Problem

  THE FOLLOWING INFORMATION IS ALLEGED: THE PATIENT RECEIVED A CELECT PLATINUM (PT) INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2014. APPROXIMATELY 6 YEARS LATER THE PATIENT WAS DIAGNOSED WITH ACUTE THROMBOSIS OF THE IVC FILTER, LEADING TO VENOUS THROMBECTOMY AND THROMBOLYSIS, AND FURTHER, THE PATIENT HAS BEEN TOLD THE FILTER CANNOT BE REMOVED. PATIENT ALLEGES FILTER THROMBOSIS, PERFORATION OF THE VENA CAVA, AND PAIN. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED, BUT NOT YET PROVIDED.

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

  MAUDE report 15624821 ↗