SafeSept® NF Transseptal Guidewire Needle Free SSNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00891492002401), received between Feb 3, 2017 and May 3, 2018 — classified as 2 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 18, 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 3, 2018Break; Material Separation; Break; Material Separation

  THE PHYSICIAN WAS ATTEMPTING TO CROSS THE SEPTUM AND THE SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE (SSNF) WOULD NOT CROSS, SO HE TRIED TO CROSS TWO MORE TIMES UNSUCCESSFULLY AND THEN REMOVED THE SSNF FROM THE DILATOR ONLY TO FIND THAT THE J TIP HAD BROKEN OFF. THEY REMOVED THE INTRODUCER AND FOUND THE BROKEN J LODGED IN THE DILATOR. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7484276 ↗
• MalfunctionFeb 3, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE UNIT, WHICH WAS REPORTED ON (B)(6), WAS RETURNED FROM THE HOSPITAL WHERE DURING A TRANSSEPTAL PROCEDURE THE PHYSICIAN ADVANCED THE SSNF THROUGH AN AGILIS SHEATH AND DILATOR AND HAD DIFFICULTY CROSSING, MET SOME RESISTANCE, AND UPON PULLING BACK THE SSNF, IT FRACTURED INTO TWO PIECES. THE SEPARATED PIECE WAS WITHIN THE AGILIS, SO THEY WERE ABLE TO EASILY RETRACT THE PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6302554 ↗