BRITE TIP 401023MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032000123), received between Aug 23, 2021 and Aug 23, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2021Unintended Movement; Unintended Movement

  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 STENOSIS, ORGAN PERFORATION AND 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. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), A CORDIS OPTEASE TYPE INFERIOR VENA CAVA (IVC) FILTER WAS IDENTIFIED THROUGH BILLING RECORDS. THE PATIENT REPORTS PERFORATION OF FILTER STRUTS OUTSIDE THE IVC, PERFORATION OF STRUTS INTO ORGANS, TILTING OF THE FILTER AND STENOSIS, BECOMING AWARE OF THESE EVENTS APPROXIMATELY ELEVEN YEARS AND THREE MONTHS AFTER THE FILTER IMPLANTATION.

  Patient problems: Internal Organ Perforation; Perforation of Vessels; Stenosis

  MAUDE report 12352964 ↗