Supreme™ 401449Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734201414), received between Dec 20, 2018 and Apr 21, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K894500); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 21, 2025Fracture; Fracture

  DURING THE PROCEDURE, A BREAK OCCURRED IN THE CATHETER. THE CATHETER WAS INTRODUCED VIA FEMORAL VENOUS WAY AND PLACED IN THE CORONARY SINUS WITHOUT DIFFICULTY. DURING INTRODUCTION OF THE SECOND CATHETER, X-RAY SHOWED DISCONTINUITY OF THE CATHETER. UPON REMOVAL OF THE DEVICE, A SEPARATION WAS NOTED BETWEEN THE BODY OF THE CATHETER AND THE DISTAL PART, WITH EXPOSURE OF THE COPPER CONDUCTORS NOTED. THERE WERE NO PATIENT CONSEQUENCES. THE PIECE IS RETAINED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874501 ↗
• MalfunctionDec 20, 2018Fracture; Fracture

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER SHAFT FRACTURED, EXPOSING THE INTERNAL COMPONENTS AFTER BEING MANEUVERED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184539 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K894500. One submission often covers many models, so check the product and lot details in each record.

• Z-0177-2015 · Oct 14, 2014 · Terminated
  St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353