Simon Nitinol Filter™ 2320ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741040924), received between Aug 31, 2018 and Oct 13, 2021 — classified as 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionOct 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2320A VENA CAVA FILTER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE OF 212 LBS WEIGHING FEMALE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738092 ↗
• MalfunctionJan 15, 2020Malposition 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

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 2320A VENA CAVA FILTER ALLEGEDLY EXPERIENCED A FILTER TILT, PERFORATION, AND DETACHMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A (B)(6) YEAR OLD MALE THAT WEIGHED (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591617 ↗
• MalfunctionAug 31, 2018Patient-Device Incompatibility; Detachment of Device or Device Component; Positioning Problem; Patient-Device Incompatibility; Detachment of Device or Device Component; Positioning 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 PRIOR TO BARIATRIC SURGERY. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER DETACHED. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7838310 ↗