Simon Nitinol Filter™ 2120FRecalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00801741040900), received between Nov 5, 2015 and May 19, 2022 — classified as 2 deaths, 45 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (50 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 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT WITH MULTIPLE TRAUMA STATUS POST MOTOR VEHICLE ACCIDENT, HEMOTHORAX AND SPINAL INJURY. APPROXIMATELY EIGHT MONTHS AND FIFTEEN DAYS POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14446837 ↗
• InjuryMar 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUT DETACHED AND THE PATIENT HAD EXTRAVASATION. ATTEMPTS WERE MADE TO RETRIEVE THE FILTER, HOWEVER REMOVAL OF THE FILTER WAS NOT CONFIRMED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 13928301 ↗
• InjuryJan 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUTS PERFORATED INTO ORGANS AND THE PATIENT REPORTEDLY EXPERIENCED ABDOMINAL PAIN. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain

  MAUDE report 13306485 ↗
• MalfunctionJan 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY PERFORATED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE FEMALE PATIENT IS (B)(6) AND WEIGHS (B)(6) POUNDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13288406 ↗
• MalfunctionJan 19, 2022Malposition of Device; Patient-Device Incompatibility; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Malposition of Device; Patient-Device Incompatibility; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem

  A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE, PERFORATION, DEPLOYMENT ISSUE, MATERIAL DEFORMATION AND POSITIONING PROBLEM. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) OLD MALE PATIENTS WEIGHT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287948 ↗
• MalfunctionOct 27, 2021Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE AND PATIENT-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE TWO MALPOSITION OF DEVICE AND PATIENT-DEVICE INCOMPATIBILITY, BOTH INVOLVED PATIENTS WITHOUT CONSEQUENCES. THE TWO FEMALE PATIENTS RANGED FROM 51 TO 62 YEARS OF AGE AND ONE PATIENT WEIGHED (B)(6) LBS. WEIGHT WAS NOT REPORTED FOR THE OTHER PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708231 ↗
• InjurySep 29, 2021Malposition of Device; Patient-Device Incompatibility; Detachment of Device or Device Component; Malposition of Device; Patient-Device Incompatibility; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED, STRUTS DETACHED AND PERFORATED INTO RETROPERITONEUM AND AORTA. THE DEVICE AND THE DETACHED STRUTS WERE REMOVED PERCUTANEOUSLY. IT WAS FURTHER REPORTED THAT THE DETACHED STRUT RETAINED IN ABDOMEN/PELVIS; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain; Foreign Body In Patient

  MAUDE report 12546026 ↗
• MalfunctionSep 24, 2021Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS, EXTENDING DESPITE ADEQUATE ANTICOAGULANT THERAPY. AT SOME TIME, POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER HAD PERFORATED AND TILTED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524423 ↗
• MalfunctionSep 16, 2021Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT WITH PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER HAD PERFORATED AND MIGRATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482245 ↗
• InjuryAug 16, 2021Malposition of Device; Patient-Device Incompatibility; Detachment of Device or Device Component; Migration; Malposition of Device; Patient-Device Incompatibility; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE STRUTS DETACHED AND RETAINED IN LUNGS. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain

  MAUDE report 12323702 ↗
• MalfunctionJul 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCE PERFORATION. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL THE SIX MALFUNCTIONS WERE INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. OF THE REPORTED SIX PATIENTS, TWO MALE PATIENTS AGES WERE RANGED FROM 48 TO 69 YEARS OLD AND FOUR FEMALE PATIENTS AGES WERE RANGED FROM 64 AND 79 YEARS OLD. WEIGHT OF TWO PATIENTS WERE RANGED BETWEEN 106 TO 235 KGS; HOWEVER, REMAINING PATIENTS WEIGHT WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193913 ↗
• MalfunctionJul 19, 2021Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION AND TILT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH THE MALFUNCTIONS WERE INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. TWO MALE PATIENT'S AGES WERE REPORTED AS (B)(6) YEARS; HOWEVER, WEIGHT OF THE PATIENTS WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12190934 ↗
• MalfunctionJul 19, 2021Malposition of Device; Detachment of Device or Device Component; Patient Device Interaction Problem; Malposition of Device; Detachment of Device or Device Component; Patient Device Interaction Problem

  A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE, PATIENT DEVICE INTERACTION PROBLEM AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THIS MALFUNCTION INVOLVED ALL TWO PATIENTS WITH NO CONSEQUENCES. TWO PATIENTS AGE WERE REPORTED RANGING FROM (B)(6) YEARS. ONE PATIENT WAS REPORTED AS FEMALE. ALL OTHER DETAILS OF THE PATIENTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12190108 ↗
• MalfunctionJul 15, 2021Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION AND DETACHMENT. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) YEARS OLD MALE PATIENT WEIGHS (B)(6) KGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12175906 ↗
• MalfunctionJul 13, 2021Malposition of Device; Patient Device Interaction Problem; Migration; Malposition of Device; Patient Device Interaction Problem; Migration

  A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2120F VENA CAVA FILTER EXPERIENCED TILT, PERFORATION AND MIGRATION. THE INFORMATION WAS RECEIVED FROM A ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE REPORTED PATIENT IS (B)(6). WEIGHT AND SEX OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163595 ↗
• InjuryJun 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUTS PERFORATED INTO ORGANS AND THE PATIENT REPORTEDLY EXPERIENCED ABDOMINAL PAIN. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain

  MAUDE report 12065072 ↗
• InjuryJun 21, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM AND CLOTTING DISORDER. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUTS PERFORATED THE INFERIOR VENA CAVA WALL. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT EXPERIENCED PAIN IN ABDOMEN; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain

  MAUDE report 12030902 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH UNKNOWN REASON. APPROXIMATELY TWELVE YEARS AND FIVE MONTHS LATER POST FILTER DEPLOYMENT, THE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 11989733 ↗
• InjuryJun 11, 2021Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS. APPROXIMATELY FIVE YEARS AND ONE MONTH POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED, AND STRUTS PERFORATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT REPORTEDLY EXPERIENCED ABDOMINAL AND BACK PAIN; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11981800 ↗
• InjuryJun 11, 2021Malposition of Device; Detachment of Device or Device Component; Patient Device Interaction Problem; Malposition of Device; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH MORBID OBESITY, HYPERCOAGULABLE STATE AND IN CONJUNCTION WITH LONG LIMB ROUX-EN-Y GASTRIC BYPASS. APPROXIMATELY THIRTEEN YEARS AND EIGHT MONTHS POST FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY (CT) CHEST, ABDOMEN AND PELVIS WITH INTRAVENOUS CONTRAST REVEALED THAT THE STRUTS FRACTURED, STRUTS PENETRATED THE AORTA, VERTEBRAL BODY AND THE FILTER WAS FOUND TO BE MODERATE ANTERIORLY TILTED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT REPORTEDLY EXPERIENCED SEVERE ABDOMINAL PAIN AND UPPER BACK PAIN; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11981547 ↗
• MalfunctionApr 22, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY PERFORATED. THE INFORMATION WAS RECEIVED FROM VARIOUS SOURCE. BOTH MALFUNCTIONS WERE INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. OF THE TWO REPORTED MALFUNCTIONS, ONE FEMALE PATIENT IS 60 YEARS AND ANOTHER PATIENT AGE IS 61 YEARS; HOWEVER, GENDER WAS NOT PROVIDED. WEIGHT FOR BOTH THE PATIENTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711393 ↗
• MalfunctionApr 21, 2021Migration or Expulsion of Device; Positioning Problem; Activation Failure; Migration or Expulsion of Device; Positioning Problem; Activation Failure

  A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2120F VENA CAVA FILTER ALLEGEDLY EXPERIENCED MIGRATION, POSITIONING ISSUE AND FAILURE TO EXPAND. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A 61 YEARS OLD FEMALE PATIENT WEIGHS 104 KGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703819 ↗
• InjuryApr 13, 2021Migration or Expulsion of Device; Patient-Device Incompatibility; Migration or Expulsion of Device; Patient-Device Incompatibility

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT IN CONJUNCTION WITH OR BEFORE ORTHOPEDIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER PERFORATED BEYOND THE INFERIOR VENA CAVA WALL. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT REPORTEDLY EXPERIENCED ABDOMINAL PAIN, HOWEVER; THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain

  MAUDE report 11656084 ↗
• InjuryApr 8, 2021Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED AND STRUTS PERFORATED THE VENA CAVA WALL AND TO THE MESENTERY. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT HAD INFLAMMATION AROUND THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain; Inflammation

  MAUDE report 11632628 ↗
• MalfunctionMar 30, 2021Migration or Expulsion of Device; Malposition of Device; Patient-Device Incompatibility; Migration or Expulsion of Device; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH PULMONARY EMBOLISM. APPROXIMATELY FIFTEEN YEARS AND NINE MONTHS POST FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE FILTER STRUTS PERFORATED, TILTED AND MIGRATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587881 ↗