Supreme™ 401451Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734201438), received between May 6, 2022 and Jul 29, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K151622, 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.

• MalfunctionJul 29, 2025Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN ADVANCING THE CATHETER, IT WAS NOTED TO BE DIFFICULT TO MANEUVER. THE CATHETER WAS REMOVED FROM THE PATIENT, AND A FRACTURE WAS FOUND ON PART OF THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645102 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 2182269-2022-00026 AND 3008452825-2022-00407. DURING A SUPRAVENTRICULAR ABLATION PROCEDURE WITH WOLFE PARKINSON WHITE SYNDROME, A PERICARDIAL EFFUSION WAS NOTED IN THE CORONARY SINUS. DURING THE PROCEDURE, ELECTRODE 7-8 OF THE STEERABLE CATHETER SHOWED NOISE AND STRETCHING ON THE SYSTEM SCREEN AND THE PHYSICIANS INVOLVED STATED HIGH IMPEDANCE WAS NOTED. THE SIGNALS OF CS 7-8 WERE HIDDEN FROM BOTH THE ENSITE PRECISION AND THE EP RECORDING SYSTEM TO CONTINUE THE PROCEDURE. ACCESS THE CORONARY SINUS (CS) WAS ATTEMPTED WITH THE STEERABLE CATHETER, AND SUBSEQUENTLY WITH THE HELP OF THE SL3 SHEATH. A NON ABBOTT GUIDEWIRE WAS THEN USED TO GUIDE THE CS CATHETER. AFTER THE CATHETERS WERE IN PLACE, THE STUDY WAS PERFORMED. THE PATIENT THEN BECAME RESTLESS AND STATS DROPPED TO APPROXIMATELY 70+. AN ECHO WAS THEN PERFORMED WHICH REVEALED AN EFFUSION. HOWEVER, THE PROCEDURE WAS ABANDONED MIDWAY THROUGH THE STUDY AS THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 14306285 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151622, 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