NA 6208-S1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00681490143172), received between Jun 8, 2017 and Jul 2, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2018Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE BOTH ENDS OF THE LEAD INTRODUCER RUPTURED DURING CUTTING. THE INTRODUCER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7655791 ↗
• MalfunctionJun 7, 2018Break; Break

  IT WAS REPORTED THAT THE PROXIMAL PART OF THE INTRODUCER WAS RIPPED DURING ITS REMOVAL AND NEEDED TO BE CUT WITH A SCISSORS WITH POSSIBLE LESION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7579283 ↗
• MalfunctionJun 8, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE INTRODUCER SHEATH WAS INSPECTED PRIOR TO USE WITH NO ISSUE NOTED. DURING SUBCLAVIAN VEIN PUNCTURE THE INTRODUCER SHEATH FRACTURED. THE INTRODUCER SHEATH WAS REPLACED WITH A NEW SHEATH TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6625378 ↗