Cook Celect G03767Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002037677), received between Jul 8, 2016 and Sep 8, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO STUDY: (B)(4) PT ¿ (B)(6): GRADE 1 & 3 FILTER LEG INTERACTION WITH IVC WALL . ON (B)(6) 2016, THE PATIENT RECEIVED A CELECT® FILTER. PRIMARY REASON FOR FILTER PLACEMENT WAS A CURRENT DEEP VEIN THROMBOSIS DUE TO A FAILURE OF ANTICOAGULATION. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 24 MM. THERE WAS NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. USING THE RIGHT COMMON FEMORAL VEIN AS THE ACCESS SITE, A CELECT® FILTER WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PULMONARY EMBOLISM. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. FILTER TILT, EXTRAVASATION OF CONTRAST, OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT WAS NOT ASSESSED DUE TO THE TECHNICAL LIMITS OF IVUS. ANALYSIS OF THE PLACEMENT PROCEDURE IVUS REVEALED NO IVC ANATOMIC ANOMALY OR THE PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE

  Patient problems: Internal Organ Perforation

  MAUDE report 6850985 ↗
• MalfunctionJul 8, 2016Malposition of Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO STUDY: THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 22.0 MM. THERE WAS NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. USING THE RIGHT COMMON FEMORAL VEIN AS THE ACCESS SITE, A CELECT® FILTER (LOT # E3110992) WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PULMONARY EMBOLISM (PE). THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. EVIDENCE OF FILTER FRACTURE, DEFORMATION, TILT, MIGRATION, EXTRAVASATION OF CONTRAST, OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST IS NOT ASSESSABLE DUE INTRAVASCULAR ULTRASOUND (IVUS) FILTER PLACEMENT. ON (B)(6) 2016, POST-PROCEDURE X-RAY, (ONE DAY POST-PROCEDURE): SITE: NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, MIGRATION (SITE QUERIED), OR TILT. ON (B)(6) 2016, PRE-RETRIEVAL X-RAY, (106 DAYS POST-PROCEDURE): SITE: NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. TILT = 16 DEGREES. PATIENT OUTCOME: THE PATIENT REMAINS IN THE CLINICAL STUDY AND NO OTHER DEVICE RELATED ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5777779 ↗