NA 6209-S1 (UDI 00643169646179)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169646179), received between Dec 22, 2021 and May 31, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INTRODUCER BROKE OPEN DURING INSERTION. A REPLACEMENT INTRODUCER WAS USED AND THE SAME ISSUE OCCURRED. THE INTRODUCER WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545906 ↗
• MalfunctionDec 22, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE RIGIDITY/STIFFNESS OF THE INTRODUCER WAS NOTED ON THE TIP OF THE DILATOR. THE INTRODUCER WAS NOT REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13058426 ↗