OptEase Vena Cava Filter 466F230AJRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032072882), received between Oct 6, 2020 and Jan 20, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (3 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 5 most recent of 5 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 6, 2020Difficult to Remove; Difficult to Remove

  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, OCCLUSION AND FILTER IRRETRIEVABLE. DOCUMENTED ATTEMPTS TO REMOVE THE FILTER WERE NOT PROVIDED. PER THE IMPLANT RECORDS, THE PATIENT WAS REPORTED TO HAVE A PREOPERATIVE DIAGNOSIS OF ACUTE DEEP VENOUS THROMBOSIS (DVT) OF THE RIGHT COMMON FEMORAL VEIN AND SEVERE MITRAL REGURGITATION. ON ULTRASOUND, THE RIGHT JUGULAR VEIN WAS LARGE, WIDELY PATENT AND EASILY COMPRESSIBLE WITH NO EVIDENCE OF DEEP VENOUS THROMBOSIS. FLUOROSCOPY WAS USED TO IDENTIFY THE BILATERAL RENAL VEINS. THE OPTEASE INFERIOR VENA CAVA (IVC) WAS DEPLOYED UNDER DIRECT VISUALIZATION AND WAS FOUND TO BE IN GOOD POSITION BETWEEN THE BIFURCATION OF THE ILIACS AND THE SUPERIOR RENAL VEIN. THE FILTER WAS PLACED BELOW THE RENAL VEINS. THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS BLOOD CLOTS, CLOTTING AND OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC), IN ADDITION TO AN UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE ATTEMPTED APPROXIMATELY

  Patient problems: Coagulation Disorder; Occlusion

  MAUDE report 10635929 ↗