FLEXIPATH FP007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705036011903), received between Nov 2, 2021 and Nov 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2021Crack; Mechanical Problem; Crack; Mechanical Problem

  T WAS REPORTED THAT DURING A RIGHT PLEURAL EFFUSION PROCEDURE, AN FP007 TROCAR BROKE WHEN USED IN PATIENT. SURGERY WAS DELAYED AN UNKNOWN AMOUNT OF TIME, HOWEVER PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741824 ↗
• MalfunctionNov 2, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A RIGHT PLEURAL EFFUSION PROCEDURE, AN FP007 TROCAR BROKE WHEN USED IN PATIENT. SURGERY WAS DELAYED AN UNKNOWN AMOUNT OF TIME, HOWEVER PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741811 ↗