OptEase Vena Cava FilterRecalls & reported problems across all models

We found 3 models of OptEase Vena Cava Filter by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2017 and Jan 20, 2023 — classified as 1 death, 27 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported OptEase Vena Cava Filter problems

OptEase Vena Cava Filter models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OptEase Vena Cava Filter 466F230AF

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  1 death19 reports
• OptEase Vena Cava Filter 466F220B

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  8 reports
• OptEase Vena Cava Filter 466F230AJ

  FILTER, INTRAVASCULAR, CARDIOVASCULAR
  5 reports

Recent OptEase Vena Cava Filter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2023Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  AS REPORTED, DURING PLACEMENT OF A 55 OPTEASE JUGULAR RETRIEVABLE VENA CAVA FILTER, A JUGULAR APPROACH WAS MADE; HOWEVER, THE COMPLAINT DEVICE WAS IMPLANTED AT AN IMPROPER REGION. THE FILTER WAS NOT IN THE INFERIOR VENA CAVA BUT IN A BRANCH OF THE INFERIOR VENA CAVA. THE BLOOD VESSELS WERE THIN, AND THE FILTER DID NOT DEPLOY AT ALL. THE PHYSICIAN TRIED TO COLLECT THE FILTER, BUT IT WAS NOT POSSIBLE BECAUSE THERE WAS NO HOOK ON THE TOP OF THE FILTER, BECAUSE IT WAS COLLECTED ONLY FROM THE LOWER LIMBS. ALTHOUGH THERE WAS NO HOOK, THE UPPER PART OF THE FILTER WAS PULLED OUT WITH A GOOSENECK, AND THE FILTER WAS UNFOLDED BY ABOUT TWO-THIRDS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218784 ↗
• InjuryOct 17, 2022Fracture; Difficult to Remove; Migration; Fracture; Difficult to Remove; Migration

  AS REPORTED BY THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO INFERIOR VENA CAVA (IVC) THROMBOSIS, FRACTURE OF THE FILTER AND PAIN. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT, INCLUDING MULTIPLE SURGERIES. 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; Device Embedded In Tissue or Plaque; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15614351 ↗
• InjuryJul 5, 2022Unintended Movement; Unintended Movement

  AS REPORTED IN THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO THE SUPERIOR END OF THE FILTER IS AT THE T11-12 INTERSPACE (SUPRARENAL LOCATION). THE FILTER IS TILTED ANTERIORLY AND LATERALLY AT THE SUPERIOR END AND CONTACTS THE INFERIOR VENA CAVA (IVC WALL). THE FILTER IS TILTED POSTERIORLY AT THE INFERIOR END AND CONTACTS THE IVC WALL. ALL THE STRUTS OF THE FILTER PERFORATE THE IVC UP TO 5MM. TWO (2) ANTERIOR STRUTS PERFORATE THE IVC WALL BOTH 5MM AND CONTACT THE RIGHT HEPATIC LOBE. ONE (1) MEDIAL STRUT PERFORATES THE IVC WALL 5MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) POSTERIOR STRUT PERFORATES THE IVC WALL 5MM AND CONTACTS THE RIGHT ADRENAL GLAND. ONE (1) POSTERIOR STRUT PERFORATES THE IVC WALL 5MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) LATERAL STRUT PERFORATES THE IVC WALL 5MM AND CONTACTS THE RIGHT HEPATIC LOBE. 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 S

  Patient problems: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14918782 ↗
• InjuryMay 27, 2022Positioning Problem; Unintended Movement; Unintended Movement

  AS REPORTED IN THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING BUT NOT LIMITED TO FILTER PERFORATION. AS A DIRECT AND PROXIMATE RESULT, 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 SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES.

  Patient problems: Coagulation Disorder; Perforation; Perforation of Vessels

  MAUDE report 14522880 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL TEAM, THE PATIENT UNDERWENT PLACEMENT OF THE OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, OCCLUSION THAT CAUSES INJURY AND DAMAGES TO THE PATIENT.

  Patient problems: Coagulation Disorder; Obstruction/Occlusion

  MAUDE report 14517424 ↗
• InjuryMay 16, 2022Defective Component

  AS REPORTED IN THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT. THE PATIENT IS AT RISK OF SUFFERING INJURIES, POSSIBLY PERMANENT AND LIFE-THREATENING, AND WILL REQUIRE EXTENSIVE MEDICAL CARE, MONITORING AND TREATMENT DUE TO LONG TERM IMPLANT OF THE INFERIOR VENA CAVA (IVC FILTER). THE PATIENT SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND OTHER LOSSES, NOT LIMITED TO THE APPREHENSION AND RISK ASSOCIATED WITH RETAINING A DEFECTIVE DEVICE INSIDE THE BODY. APPROXIMATELY FIVE MONTHS AFTER THE INDEX PROCEDURE AN ABDOMINAL COMPUTED TOMOGRAPHY (CT) SCAN WAS DONE TO EVALUATE THE INFERIOR VENA CAVA, UNSPECIFIED INJURY. THE IMAGES DEPICT A CORDIS TYPE IVC FILTER AND INCOMPLETELY VISUALIZED RIGHT COMMON AND EXTERNAL ILIAC VENOUS STENTS. THE IMAGES REVEALED: CHOLECYSTECTOMY CLIPS, SEVERAL SUBCUTANEOUS VENOUS COLLATERAL AND THE INFERIOR VENA CAVA (IVC) FILTER WAS NOTED. THERE WAS NO EVIDENCE TO SUGGEST IVC PERFORATION ON THE IMAGES. ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Coagulation Disorder; Obstruction/Occlusion; Pulmonary Embolism

  MAUDE report 14407634 ↗
• DeathApr 4, 2022Fracture; Fracture

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE 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 FRACTURE AND ORGAN 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Internal Organ Perforation; Perforation of Vessels

  MAUDE report 14005768 ↗
• InjuryMar 24, 2022Difficult to Remove; Unintended Movement; Difficult to Remove; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO TILT, PERFORATION, AND AN UNSUCCESSFUL REMOVAL ATTEMPT. 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: Coagulation Disorder; Embolism/Embolus; Perforation; Perforation of Vessels; Stenosis; Thrombosis/Thrombus

  MAUDE report 13896504 ↗
• InjuryMar 4, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE 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 AND PAIN. 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: Coagulation Disorder; Pain; Unspecified Tissue Injury

  MAUDE report 13669040 ↗
• InjuryJan 13, 2022Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO: ORGAN PERFORATION AND TILT. AS A DIRECT AND PROXIMATE RESULT, 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: Internal Organ Perforation; Perforation of Vessels

  MAUDE report 13254299 ↗
• InjuryJan 6, 2022Unintended Movement; Unintended Movement

  AS REPORTED IN THE LEGAL BRIEF A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO FILTER TILTING. AS A DIRECT AND PROXIMATE RESULT, 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 SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13176215 ↗
• InjuryAug 27, 2021Unintended Movement; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO FILTER TILTING. AS A DIRECT AND PROXIMATE RESULT, 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 SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES. PER THE IMPLANT RECORDS, THE PATIENT WAS REPORTED TO HAVE A HISTORY OF ACUTE SADDLE PULMONARY EMBOLISM (PE) WITHOUT ACUTE COR PULMONALE. PLACEMENT OF THE INFERIOR VENA CAVA (IVC) FILTER WAS ADVISED FOR LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) WITH CONTRAINDICATION TO ANTICOAGULATION TO PREVENT A PE. UTILIZING ROUTINE STERILE TECHNIQUE, AN ULTRASOUND OF THE RIGHT INTERNAL JUGULAR VEIN WAS PERFORMED, CONFIRMING A WIDELY PATENT RIGHT INTERNAL JUGULAR VEIN. USING DIRECT ULTRASOUND GUIDANCE, THE RIGHT INTERNAL JUGULAR VEIN WAS PUNCTURED, AND A GUIDEWIRE WAS ADVANCED INTO THE INFERIOR VENA CAVA UNDER FLUOROSCOPY GUIDANCE, FOLLOWED BY A CATHETER. A DIAGNOSTIC VENA CAVOGRAM WAS THEN PERFORM

  Patient problems: Anxiety; Chest Pain; Dyspnea; Pain; Unspecified Tissue Injury

  MAUDE report 12376611 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE 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. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF DEEP VEIN THROMBOSIS (DVT) IN LEFT POPLITEAL, ABDOMINAL PAIN, ATYPICAL CHEST PAIN, DYSPNEA, MULTIPLE GASTROINTESTINAL BLEEDING, MULTIPLE BILATERAL PULMONARY EMBOLISMS, ANGIOECTASIAS OF ESOPHAGUS AND COLON, IRON DEFICIENCY ANEMIA, CHRONIC CRAMPS, HYPOTENSION AND SCLERODERMA WHICH INCLUDES TELANGIECTASIA. THE PATIENT WAS HOSPITALIZED TWO WEEKS PRIOR FOR ANEMIA. THE PATIENT PRESENTED AT THE HOSPITAL WITH SHARP RIGHT UPPER QUADRANT PAIN THAT RADIATED TO RIGHT SHOULDER AND BACK. IT WORSENED WITH BREATHING. SHE EXPERIENCED DIFFICULTY BREATHI

  Patient problems: Perforation of Vessels

  MAUDE report 12351182 ↗
• InjuryAug 2, 2021Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF MORBID OBESITY AND HYPERCOAGULABLE STATE. THE INDICATION FOR THE FILTER PLACEMENT WAS PROPHYLAXIS PRIOR TO GASTRIC BYPASS SURGERY DUE TO A HIGH RISK FOR THROMBOEMBOLISM. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND WAS DEPLOYED AT THE L2-L3 INTERVERTEBRAL DISK. APPROXIMATELY EIGHT MONTHS LATER A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN WAS PERFORMED, THE INDICATION FOR THE EXAM WAS NOT PROVIDED. RESULTS NOTED THE FILTER IS IN PLACE, A 3CM RIGHT ADNEXAL CYST, SMALL FAT CONTAINING VENTRAL HERNIA AND DIFFUSE SIGNIFICANT FATTY LIVER. ONE YEAR AND FOUR MONTHS LATER A DUPLEX ULTRASOUND OF THE LOWER EXTREMITIES WAS PERFORMED. HISTORY NOTED AT THE TIME OF THE EXAM WAS ELEVATED D-DIMER, ANEMIA AND ANXIETY. THE EXAM WAS NEGATIVE FOR DEEP VEIN THROMBOSIS. APPROXIMATELY THREE YEARS AND FIVE MONTHS POST IMPLANT AN ABDOMINAL CT SCAN WAS PERFORMED FOR ABDOMINAL PAIN. RESULTS OF THE SCAN NOTED THE FILTER IS TILTED AND ONE LEG OF THE FILTER QUESTIONABLY PROJECTS BEYOND THE IVC. THE FILTER APPEARS INTACT. THE LIVER WAS NOTED TO APPEAR NORMAL IN THIS SCAN. ADDITIONAL INFORMATION RECEI

  Patient problems: Perforation of Vessels

  MAUDE report 12264567 ↗
• InjuryJun 2, 2021Filling Problem; Therapeutic or Diagnostic Output Failure

  THE PATIENT IS REPORTED TO HAVE A HISTORY OF DVT AND PRIOR TO THE INDEX PROCEDURE, RESULTS OF A BILATERAL LOWER EXTREMITY ULTRASOUND SHOWED A RECENT DVT WITHIN THE MID AND RIGHT LOWER SUPERFICIAL FEMORAL VEIN. PER THE OPERATIVE REPORT, THE RIGHT FEMORAL VEIN WAS PUNCTURED FOLLOWED BY PLACEMENT OF A SHEATH, AND A GUIDEWIRE AND CATHETER WERE USED TO SELECT THE RIGHT AND LEFT RENAL VEINS. DIGITAL SUBTRACTION ANGIOGRAPHY WAS USED TO OBTAIN A CAVOGRAM. AN OPTEASE VENA CAVA FILTER WAS PLACED BELOW THE LEVEL OF THE RENAL VEINS. CONTRAST INJECTION FOLLOWING PLACEMENT OF THE FILTER DEMONSTRATED APPROPRIATE POSITIONING. THERE WERE NO COMPLICATIONS. THE REVIEW OF THE ADDITIONAL MEDICAL RECORDS PROVIDED REVEALED THAT ABOUT THREE DAYS AFTER THE FILTER WAS IMPLANTED, THE PATIENT UNDERWENT AN ABDOMINAL ULTRASOUND. THE REPORT NOTED THAT THE GALLBLADDER HAD BEEN SURGICALLY REMOVED, IN ADDITION TO A HYPOECHOIC LESION ON THE LEFT LOBE OF THE LIVER (RELATED TO INJURY) AND A SIMPLE CYST WITHIN THE MIDPOLE OF THE RIGHT KIDNEY. APPROXIMATELY A MONTH AFTER THE FILTER WAS IMPLANTED, AN ABDOMINAL X-RAY WAS PERFORMED FOR PERSISTENT PAIN POST LAPAROTOMY FOR STAB WOUND, AND GASTRIC DISTENTION WAS OBSERVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11919094 ↗

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