Supreme™ 402004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734201995), received between Jun 25, 2018 and Oct 31, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Fracture; Fracture

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER FRACTURED WHILE INSERTED IN THE PATIENT. THE CATHETER WAS PLACED IN THE RIGHT ATRIUM THROUGH THE SUPERIOR VENA CAVA WHEN IT WAS NOTICED ON X-RAY THAT THE EXTERNAL DISTAL PART OF THE CATHETER WAS FRACTURED WITH JUST THE INNER WIRE CONNECTING THE TWO PARTS. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433495 ↗
• MalfunctionJun 24, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER SHAFT DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601663 ↗
• MalfunctionFeb 7, 2024Fracture; Difficult to Insert; Material Twisted/Bent; Fracture; Difficult to Insert; Material Twisted/Bent

  DURING THE ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE, WHEN INSERTING THE CATHETER THROUGH THE FEMORAL VEIN ACCESS, RESISTANCE WAS MET. MORE FORCE WAS USED WITH NO RESOLUTION. THE CATHETER WAS REMOVED AND IT WAS NOTED TO BE FRACTURED AND BENT. THE CATHETER AND INTRODUCER WERE BOTH REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659508 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 2182269-2022-00026, 3008452825-2022-00408. 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 14306196 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00421, 3005334138-2019-00422, 3008452825-2019-00385, 3008452825-2019-00387. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING GEOMETRY COLLECTION AND ABLATION OF THE RIGHT-SIDED UPPER PULMONARY VEIN, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED AN EFFUSION. A TAMPONADE WAS DIAGNOSED AND A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 8876582 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2018-00189, 3008452825-2018-00190, 3005334138-2018-00171, 3008452825-2018-00191, 3005334138-2018-00172, 2030404-2018-00046, 3005334138-2018-00173. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. DURING ROUTINE ECHOCARDIOGRAPHY A SMALL EFFUSION WAS DIAGNOSED. THE PATIENT'S BLOOD PRESSURE WAS STABLE. OCTAPLEX WAS ADMINISTERED TO REVERSE ANTICOAGULANT THERAPY AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT. THE PATIENT RECOVERED AND WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 7633426 ↗

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