NA 6209-S5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169646292), received between Oct 11, 2021 and Oct 27, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionOct 27, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE, THE INTRODUCER SHEATH FAILED TO SPLIT.  THE TWO WINGS ON THE INTRODUCER SHEATH BROKE OFF INSTEAD OF SNAPPING AND SPLITTING.  THE PHYSICIAN HAD TO MANUALLY CUT THE INTRODUCER SHEATH AWAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678801 ↗
• MalfunctionOct 11, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE THE INTRODUCER SHEATH WOULD NOT SNAP. THE PHYSICIAN CUT THE SHEATH WITH A SCISSORS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12604884 ↗