TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306BURecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032009475), received between Nov 21, 2017 and Sep 19, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2022Fracture; Fracture

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO SPECIFIC EVIDENCE THAT THE FILTER HAD A BROKEN STRUT AND A PREVIOUSLY PLACED RIGHT COMMON ILIAC STENT DEMONSTRATED APPROXIMATELY 50% STENOSIS WHICH REQUIRED TREATMENT WITH BALLOON ANGIOPLASTY. THE FILTER WAS REMOVED. AN 8 FRENCH SHEATH AND PIGTAIL CATHETER WERE USED IN AN ATTEMPT TO RETRIEVE THE FILTER, BUT THEN REQUIRED A LASER DEVICE TO BE INSERTED THROUGH THE RIGHT GROIN AND RIGHT NECK TO FREE UP THE FILTER FROM THE INFERIOR VENA CAVA (IVC) WALL. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF RIGHT LEG DEEP VEIN THROMBOSIS (DVT), THERE WAS SOME IMPROVEMENT WITH TPA THERAPY. THE PATIENT HAD EXPERIENCED CHEST PAIN WITH ACUTE

  Patient problems: Coagulation Disorder; Device Embedded In Tissue or Plaque; Stenosis

  MAUDE report 15446616 ↗
• InjuryMar 4, 2022Fracture; Fracture

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PERFORATIONS OF ALL STRUTS AND UNUSUAL CONFIGURATION OF STRUT SUGGESTING FRACTURE. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Pain; Perforation; Perforation of Vessels

  MAUDE report 13670229 ↗
• InjuryAug 20, 2021Material Perforation

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO FILTER PERFORATION. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF PULMONARY EMBOLISM. THE FILTER WAS DEPLOYED VIA THE PATIENT'S LEFT GROIN. THE PATIENT TOLERATED THE PROCEDURE WELL.   ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED PERFORATION OF FILTER STRUTS OUTSIDE THE INFERIOR VENA CAVA. THE PATIENT BECAME AWARE OF THE REPORTED EVENT APPROXIMATELY TEN YEARS AFTER THE INDEX PROCEDURE. THE PATIENT ALSO EXPERIENCED DEPRESSION, ANXIETY, FEAR, SWELLING, BRUISES, LEG PAIN AND ABDOMINAL PAIN.

  Patient problems: Perforation of Vessels

  MAUDE report 12350793 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF CHRONIC IRON DEFICIENCY ANEMIA, CHEST PAIN, LEFT PLEURAL EFFUSION WITH ATELECTASIS, ELEVATED LEFT HEMIDIAPHRAGM, DIABETES, GASTRIC ARTERIOVENOUS MALFORMATION, DIVERTICULOSIS, HEMORRHOIDS, ADRENAL INSUFFICIENCY, PAROXYSMAL ATRIAL FIBRILLATION, PARAPLEGIA SECONDARY TO A MOTOR VEHICLE ACCIDENT, POST-TRAUMATIC STRESS DISORDER, ALLERGIC RHINITIS, CHRONIC PAIN SYNDROME, AUTONOMIC DYSREFLEXIA, NEUROGENIC BLADDER (HAS A SUPRAPUBIC CATHETER), SEIZURES, HOMOCYSTINEMIA, PROTEIN S DEFICIENCY, HIATAL HERNIA, GASTRIC REFLUX DISEASE, GASTRIC LEIOMYOMA, CVA X2, DEGENERATIVE JOINT DISEASE, MITRAL VALVE PROLAPSE, INSOMNIA, AND HYPERCOAGULABLE STATE. THE INDICATION FOR THE FILTER PLACEMENT WAS LEFT LEG DEEP VEIN THROMBOSIS (DVT) AND INABILITY TO ANTICOAGULATE DUE TO DROP IN HEMATOCRIT AND HEMOGLOBIN. THE FILTER WAS DEPLOYED IN THE INFRARENAL INFERIOR VENA CAVA (IVC). FILTER PLACEMENT WAS IMMEDIATELY FOLLOWED BY PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE VIA THE RIGHT BASILIC VEIN. NINE DAYS POST IMPLANT, A MAGNETIC RESONANCE IMAGING (MRI) OF THE ABDOMEN WAS PERFORMED TO RULE OUT A

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

  MAUDE report 12264525 ↗
• InjuryJul 30, 2021Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF CHRONIC BACK PAIN (SIX BACK SURGERIES), RESIDUAL LEFT LOWER EXTREMITY WEAKNESS, TOXIC OVERDOSE AND CHRONICALLY IMMOBILE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SHORTNESS OF BREATH, CHEST PAIN, DIAPHORESIS, NAUSEA AND WORSENING LEFT LEG SWELLING. THE INDICATION FOR THE FILTER IMPLANT WAS SADDLE PULMONARY EMBOLISM WITH PROXIMAL CLOT IN THE POPLITEAL VEIN AND DEEP VEIN THROMBOSIS OF THE RIGHT LEG. THE FILTER WAS PLACED VIA THE RIGHT BRACHIAL VEIN AND WAS DEPLOYED IN GOOD POSITION WITH THE TIP AT THE TOP OF THE L2 LEVEL. ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED FILTER TILT. THE PATIENT BECAME AWARE OF THE REPORTED EVENT APPROXIMATELY ELEVEN YEARS AND TWO MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT ALSO REPORTS MENTAL ANGUISH RELATED TO THE FILTER.

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

  MAUDE report 12255127 ↗
• InjuryFeb 14, 2020Fracture; Difficult to Remove; Failure to Align; Fracture; Difficult to Remove; Failure to Align

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO TILT, PERFORATION OF ALL STRUT(S) OUTSIDE THE WALL OF THE INFERIOR VENA CAVA (IVC) WITH MULTIPLE STRUTS PERFORATING INTO SURROUNDING TISSUE/ORGANS AND FRACTURE OF ONE OR MORE OF THE STRUTS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF HYPERTENSION, GOUT AND NEUROPATHY. PRIOR TO THE IMPLANT, THE PATIENT PRESENTED AT THE EMERGENCY ROOM (ER) WITH SYNCOPE, REQUIRED RESUSCITATION AND WAS DIAGNOSED WITH ACUTE MYOCARDIAL INFARCTION (MI) SECONDARY TO THROMBOSIS OF THE LEFT CIRCUMFLEX ARTERY (LCX) ARTERY. ALSO IDENTIFIED AT THE TIME WAS EXTENSIVE BILATERAL AND SADDLE PULMONARY THROMBOSIS (PT). AN ULTRASO

  Patient problems: Internal Organ Perforation; No Code Available; Perforation of Vessels; Stenosis; Thrombosis

  MAUDE report 9711885 ↗
• InjuryMay 14, 2019Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING BUT NOT LIMITED TO FRACTURED, STRUT PIECES EMBEDDED IN THE INFERIOR VENA CAVA (IVC) WALL AND INABILITY TO RETRIEVE FILTER STRUTS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) INDICATES THAT THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY 157 MONTHS AND 23 DAYS POST IMPLANTATION. THE PPF STATES THAT THE FILTER EMBEDDED IN THE WALL OF THE IVC AND THE DEVICE WAS UNABLE TO BE RETRIEVED. AT AROUND THIS TIME, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ABDOMINAL PAIN. THE PATIENT UNDERWENT AN ATTEMPT TO REMOVE THE IVC FILTER PERCUTANEOUSLY, HOWEVER, THE REMOVAL PROCEDURE WAS UNSUCCESSFUL. THE FRACTURED STRUTS ARE REMAINING AROUND THE M

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8607863 ↗
• InjuryApr 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL DEPARTMENT, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING BUT NOT LIMITED TO BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE IVC. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF MORBID OBESITY. DURING IMPLANTATION OF THE FIRST FILTER VIA THE RIGHT COMMON FEMORAL VEIN, THE PHYSICIAN EMPLOYED AN INFRARENAL INFERIOR VENA CAVA (IVC) FILTER WITHOUT DIFFICULTY. APPROXIMATELY ON OR ABOUT FOUR DAYS POST IMPLANTATION OF THE SECOND IVC FILTER, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE CHEST DUE TO ABDOMINAL PAIN, SHORTNESS OF BREATH AND HISTORY OF GASTRIC BANDING. THE CT SCAN REPORT NOTES THERE ARE PULMONARY EMBOLI WITHIN THE RIGHT LOWER LOBE AND MILD DEP

  Patient problems: No Code Available; Pulmonary Embolism; Respiratory Distress; Thrombosis

  MAUDE report 8476053 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS INDICATED IN A LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, BLOOD CLOTS, CLOTTING AND OCCLUSION OF IVC FILTER. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES.

  Patient problems: Coagulation Disorder; Occlusion

  MAUDE report 7050252 ↗