OptEase Vena Cava Filter 466F220BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032009420), received between Jul 17, 2020 and Oct 17, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 12, 2020Fracture; Unintended Movement; Fracture; Unintended Movement

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A 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 FRACTURE, PERFORATION OF IVC, TILT, AND PERFORATION ABUTTING ORGAN. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE FILTER WAS IMPLANTED PROPHYLACTICALLY PRIOR TO BARIATRIC SURGERY. THE PATIENT WAS TO HAVE A GASTRIC BYPASS PROCEDURE. A FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. INITIALLY A G-2 FILTER (MANUFACTURER: BARD) WAS ADVANCED INTO THE PATIENT. THEN IT WAS DETERMINED THAT THIS WOULD NOT WORK AND THE G-2 FILTER WAS NOT DEPLOYED. IT WAS DETERMINED THAT AN OPTEASE FILTER WOULD BE USED. THE OPTEASE FILTER WAS ADVANCED AND DEPLOYED SUCCESSFULLY. AN ANGIOGRAM SHOWED THAT THE LOCATION OF THE FILTER WAS APPROPRIATE. IT WAS 3 CM DISTAL TO THE LOWEST RENAL VEIN ON THE RIGHT SIDE. THERE WERE NO COMPLICATIONS. INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED FRACTURE WITHIN THE INFERIOR VENA CAVA (IVC) AND PERFORATION OF FILTER STRUTS OUTSIDE THE INFERIOR VENA CAVA (IVC) WITH THE

  Patient problems: Perforation of Vessels

  MAUDE report 10667465 ↗
• InjuryJul 17, 2020Fracture; Migration; Fracture; Migration

  AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A 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 FRACTURE, EMBEDMENT AND OCCLUSION. INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF DEEP VEIN THROMBOSIS IN LEFT LEG. THE PATIENT HAD A L5-S1 LAMINECTOMY APPROXIMATELY ONE MONTH PRIOR. THE FILTER WAS DEPLOYED VIA THE PATIENT'S RIGHT COMMON FEMORAL VEIN. IN ADDITION TO THE FILTER PLACEMENT PROCEDURE, THE PATIENT ALSO UNDERWENT LEFT ILIOFEMORAL THROMBECTOMY AND ANGIOPLASTY AND STENTING WITH TWO WALLSTENTS (14X90) FOR ILIOFEMORAL VENOUS STENOSIS THE SAME DAY. INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED FILTER FRACTURE WITHIN THE VENA CAVA AND THE RIGHT VENTRICULAR WALL, EMBEDDED, BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC). THERE WAS A REMOVAL ATTEMPT EIGHT YEARS AND EIGHT MONTHS AFTER THE INDEX PROCEDURE AND A SECOND REMOVAL ATTEMPT EIGHT YEARS AND TEN MONTHS AFTER THE INDEX PROCEDURE. FILTER FRAGMENTS REMAIN WITHIN THE PATIENT'S VENA CAVA AND R

  Patient problems: Embolus; Occlusion; Vessel Or Plaque, Device Embedded In

  MAUDE report 10289013 ↗