Simon Nitinol Filter™ 2220JRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741040917), received between Feb 13, 2017 and Apr 28, 2022 — classified as 1 death, 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 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 PULMONARY EMBOLISM. APPROXIMATELY NINE YEARS AND TWO MONTHS POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUT PERFORATED 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 14239647 ↗
• MalfunctionOct 18, 2021Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE AND PERFORATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) FEMALE PATIENT WEIGHS 200 LBS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12645752 ↗
• MalfunctionJul 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER EXPERIENCED PERFORATION. THE INFORMATION WAS RECEIVED FROM A ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE FEMALE PATIENT IS (B)(6). WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191593 ↗
• InjuryJun 11, 2021Obstruction of Flow; Obstruction of Flow

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

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 11981712 ↗
• MalfunctionApr 16, 2021Migration or Expulsion of Device; Patient-Device Incompatibility; Detachment of Device or Device Component; Migration or Expulsion of Device; Patient-Device Incompatibility; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER EXPERIENCED DETACHMENT, PERFORATION AND MIGRATION. THE INFORMATION WAS RECEIVED FROM A ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE MALE PATIENT IS (B)(6). WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682577 ↗
• MalfunctionJan 20, 2021Malposition of Device; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 40 YEAR OLD MALE PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205426 ↗
• MalfunctionJan 20, 2021Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 70 YEAR OLD FEMALE PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205407 ↗
• MalfunctionJan 20, 2021Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MIGRATION AND PERFORATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. A (B)(6) MALE PATIENT WEIGHS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205405 ↗
• MalfunctionJan 20, 2021Migration or Expulsion of Device; Malposition of Device; Material Deformation; Migration or Expulsion of Device; Malposition of Device; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MIGRATION, PERFORATION, TILT AND MATERIAL DEFORMATION. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE FEMALE PATIENT IS (B)(6). WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205346 ↗
• InjuryJan 13, 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 IN CONJUNCTION WITH OR BEFORE BARIATRIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT FILTER STRUTS PERFORATED AND TILTED. 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 11159842 ↗
• InjuryDec 1, 2020Difficult to Remove; Detachment of Device or Device Component; Patient Device Interaction Problem; Difficult to Remove; 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 IN CONJUNCTION WITH OR BEFORE BARIATRIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER STRUTS DETACHED AND PERFORATED OUTSIDE THE INFERIOR VENA CAVA WALL. THE DEVICE WAS REMOVED PERCUTANEOUSLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain

  MAUDE report 10926975 ↗
• MalfunctionOct 26, 2020Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE AND PATIENT DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737986 ↗
• MalfunctionOct 26, 2020Difficult to Remove; Malposition of Device; Patient Device Interaction Problem; Difficult to Remove; Malposition of Device; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE, MALPOSITION OF DEVICE AND PATIENT DEVICE INTERACTION PROBLEM. 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) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737982 ↗
• MalfunctionOct 26, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED DETACHMENT AND PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL MALFUNCTIONS INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. OUT OF THREE MALFUNCTIONS TWO PATIENT WERE FEMALE RANGING FROM 37 AND 80. HOWEVER, THE WEIGHTS WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737953 ↗
• InjuryJul 22, 2020Malposition 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 AND RECURRENT PULMONARY EMBOLISM. APPROXIMATELY TWO YEARS AND FIVE MONTHS POST FILTER DEPLOYMENT, A COMPUTED TOMOGRAPHY (CT) ABDOMEN AND PELVIS WITHOUT INTRAVENOUS CONTRAST ALLEGED THAT THE FILTER TILTED AND FILTER STRUTS PERFORATED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM POST IMPLANT AND REPORTEDLY EXPERIENCED ABDOMINAL PAIN; HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abdominal Pain; Pulmonary Embolism

  MAUDE report 10306506 ↗
• MalfunctionJul 17, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THIS MALFUNCTION INVOLVED A PATIENTS WITH NO CONSEQUENCES. ONE PATIENT WAS (B)(6) YEARS OLD FEMALE AND ANOTHER ONE WAS (B)(6)YEARS OLD MALE. WEIGHT OF THE PATIENTS WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289448 ↗
• MalfunctionJul 16, 2020Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION AND TILT. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE MALE PATIENT IS (B)(6) YEARS OLD. WEIGHT OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286686 ↗
• InjuryJul 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT WITH MORBID OBESITY. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER PERFORATED THE WALL OF THE INFERIOR VENA CAVA. 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 10232311 ↗
• MalfunctionOct 21, 2019Migration or Expulsion of Device; Malposition of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Malposition of Device; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE EVENT INDICATED THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY PERFORATED, TILTED AND MIGRATED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A (B)(6) YEAR OLD FEMALE WHOSE WEIGHT WAS NOT PROVIDED. PATIENT HAD NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214209 ↗
• MalfunctionOct 21, 2019Malposition of Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Malposition of Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2220J VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE THREE MALFUNCTIONS INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. ALL THREE PATIENTS WERE REPORTED AS FEMALES BETWEEN THE AGES OF 55 AND 65. ONE PATIENT WEIGHT WAS REPORTED AS 309 LBS, THE REMAINING TWO PATIENTS' WEIGHTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9214207 ↗
• InjurySep 11, 2019Malposition of Device; Malposition of Device

  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, THE FILTER TILTED AND THERE WAS THROMBUS EXTENDING SUPERIOR TO THE FILTER. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombus

  MAUDE report 8987609 ↗
• MalfunctionJun 14, 2018Extrusion; Extrusion

  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 THE ORGANS. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7603410 ↗
• InjuryDec 19, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE PATIENT EXPERIENCED A PULMONARY EMBOLISM. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Chest Pain; Pulmonary Embolism

  MAUDE report 7131632 ↗
• MalfunctionNov 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED IN A PATIENT IN CONJUNCTION WITH OR BEFORE A BARIATRIC PROCEDURE. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER COULD NOT BE RETRIEVED, HOWEVER, THERE WERE NO REPORTED FILTER RETRIEVAL ATTEMPTS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7039467 ↗
• DeathAug 31, 2017Malposition of Device; Patient-Device Incompatibility; Extrusion; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Patient-Device Incompatibility; Extrusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT AN UNKNOWN TIME POST FILTER DEPLOYMENT, THE FILTER ALLEGEDLY TILTED AND EMBEDDED IN THE WALL OF THE INFERIOR VENA CAVA. ADDITIONALLY, FILTER STRUT(S) PERFORATED INTO ORGANS. THE PLAINTIFF ALLEGEDLY EXPERIENCED BLEEDING AND SUBSEQUENTLY EXPIRED. THE FILTER WAS REMOVED VIA AN OPEN ABDOMINAL PROCEDURE DURING THE AUTOPSY.

  Patient problems: Death; Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Pulmonary Embolism; Vessel Or Plaque, Device Embedded In

  MAUDE report 6835354 ↗