Swartz™ 407441Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734205658), received between May 13, 2021 and Nov 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionNov 11, 2022Material Frayed; Material Frayed

  DURING A WOLFF-PARKINSON-WHITE SYNDROME PROCEDURE, THE DILATOR WAS NOTED TO BE FLATTENED AND AN ADDITIONAL ACCESS SITE WAS NECESSARY FOR REPLACEMENT. WHEN ATTEMPTING TO INSERT THE INTRODUCER, THE TIP OF THE DILATOR WAS FOUND TO BE SLIGHTLY FLATTENED. AN ADDITIONAL ACCESS SITE WAS REQUIRED TO REPLACE THE INTRODUCER AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781355 ↗
• InjuryMay 13, 2021Fracture; Fracture

  FOLLOWING A SUCCESSFUL PROCEDURE, DIFFICULTY WAS NOTED WHEN WITHDRAWING THE INTRODUCER. THE TIP OF THE INTRODUCER WAS THEN NOTED TO PARTIALLY SEPARATE WHEN REMOVING THE INTRODUCER FROM THE PATIENT. A SMALL INCISION WAS MADE AT THE ACCESS SITE AND THE PHYSICIAN WAS ABLE TO RETRIEVE THE INTRODUCER TIP WITH A HEMOSTAT SO THE INTRODUCER COULD BE REMOVED FROM THE PATIENT WITHOUT THE TIP FULLY DETACHING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OUTSIDE OF AN EXTRA SUTURE NEEDED AT THE ACCESS SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820511 ↗