NA 6209-S1 (UDI 00681490143349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00681490143349), received between Apr 6, 2017 and Sep 2, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN COMMENTED THE "SHEATH WAS IMPROPER" DUE TO MORE GAP BETWEEN DILATOR AND SHEATH THAT RESULT IN TRAUMA TO THE VESSEL CAUSING MORE PERI LEAD OOZING POST OPERATIVE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined; No Code Available

  MAUDE report 10484814 ↗
• MalfunctionMar 24, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE TIP OF THE INTRODUCER BECAME DEFORMED CREATING A SHARP TIP ON THE BORDER OF THE INTRODUCER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9871047 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT THE INTRODUCER WAS VERY FRAGILE AND THERE WAS A FRACTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9277967 ↗
• MalfunctionMar 7, 2019Break; Break

  IT WAS REPORTED THAT THE INTRODUCER BECAME DAMAGED DURING THE IMPLANT PROCEDURE. THE DAMAGE WAS DESCRIBED AS BEING "LOOSE" OR "DETACHED". NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8401900 ↗
• MalfunctionApr 6, 2017Break; Break

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE THE GUIDE WIRE OF INTRODUCER SHEATH WAS DAMAGED, THE METAL THREAD WAS ¿FRAYED¿. THE GUIDE WIRE WAS REPLACED WITH A DIFFERENT PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6469261 ↗