Simon Nitinol FilterRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 124
- Deaths reported
- 3
- Injuries reported
- 55
- Recalls
- 0
We found 3 models of Simon Nitinol Filter by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 124 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2015 and May 19, 2022 — classified as 3 deaths, 55 injuries, 66 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (64 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 Simon Nitinol Filter problems
Device problems
- Patient Device Interaction Problem64
- Malposition of Device59
- Detachment of Device or Device Component30
- Patient-Device Incompatibility30
- Migration or Expulsion of Device19
- Adverse Event Without Identified Device or Use Problem12
- Difficult to Remove11
- Material Deformation6
Patient problems
- No Consequences Or Impact To Patient46
- No Clinical Signs, Symptoms or Conditions27
- Abdominal Pain26
- Pulmonary Embolism19
- Pain6
- Occlusion5
- Thrombus5
- Great Vessel Perforation4
Simon Nitinol Filter models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Simon Nitinol Filter™ 2120FFILTER, INTRAVASCULAR, CARDIOVASCULAR2 deaths92 reports
- Simon Nitinol Filter™ 2220JFILTER, INTRAVASCULAR, CARDIOVASCULAR1 death28 reports
- Simon Nitinol Filter™ 2320AFILTER, INTRAVASCULAR, CARDIOVASCULAR4 reports
Recent Simon Nitinol Filter adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗MalfunctionOct 13, 2021Patient-Device Incompatibility; Detachment of Device or Device Component; Patient-Device Incompatibility; Detachment of Device or Device Component
A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2320A VENA CAVA FILTER ALLEGEDLY EXPERIENCED PERFORATION AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) FEMALE PATIENT WEIGHS (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12621414 ↗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, 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 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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