SELECTSITE™ C304S5906Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994729781), received between May 10, 2018 and May 14, 2019 — 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 14, 2019Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CATHETER'S HUB AND FIRST PORTION BROKE DURING SLITTING. THE PROCEDURE COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8607267 ↗
• MalfunctionMay 10, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHILE SLITTING THE SHEATH, IT COULD NOT BE SLIT WHEN THE PHYSICIAN REACHED THE TIP. THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7505382 ↗