Supreme™ 401450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734201421), received between Jun 27, 2020 and May 26, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Entrapment of Device; Entrapment of Device

  RELATED MANUFACTURING REF: 3008452825-2022-00441. DURING THE PROCEDURE, THE CATHETERS BECAME ENTANGLED WITH EACH OTHER. WHILE MAPPING IN THE RIGHT ATRIUM, THE HD GRID CATHETER WENT INTO THE RIGHT VENTRICLE (RV) AND THE RV CATHETER (JSN) WENT THROUGH THE OPENING BETWEEN THE SPLINES OF THE HD GRID CATHETER. THE PHYSICIAN WAS UNAWARE THAT THE RV CATHETER WENT THROUGH THE SPLINES AND PULLED THE HD GRID CATHETER BACK INTO THE SRO SHEATH TO REMOVE IT. WHEN DOING SO, THE JSN CATHETER WAS PULLED INTO THE SHEATH AND PULLED HARDER TO REMOVE HD GRID. FLUOROSCOPY REVEALED THE JSN CATHETER WAS DOUBLED OVER AND STICKING OUT OF THE TOP OF THE SRO SHEATH. BOTH CATHETERS WERE STUCK IN THE SHEATH. TECH SERVICES WAS CONTACTED AND WHILE ON THE PHONE, THE PHYSICIAN PUSHED AND THE TWO CATHETERS FINALLY CAME OUT THE DISTAL END OF THE SRO AND WAS ABLE TO REMOVE THE JSN, THEN THE GRID. BOTH CATHETERS WERE INTACT, BUT BENT. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518588 ↗
• InjuryMay 26, 2022Material Separation; Material Separation

  DURING THE PROCEDURE, WHEN ATTEMPTING TO EXCHANGE THE DEVICE AND PULLING ON THE CATHETER, THE SHAFT BROKE INTO 2 PIECES. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515545 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTIONS ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. DURING PACING WITH THE ABLATION CATHETER, IT WAS INDICATED THE QUAD CATHETER PERFORATED THE RIGHT VENTRICLE. THE PATIENT WAS NAUSEATED AND AN ULTRASOUND CONFIRMED AN EFFUSION ON THE RIGHT SIDE OF THE HEART FOR WHICH A PERICARDIOCENTESIS WAS ADMINISTERED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 10372710 ↗
• MalfunctionJun 27, 2020Material Frayed; Material Frayed

  DURING A PROCEDURE, THE CATHETER WOULD NOT ADVANCE CORRECTLY AND WAS PROLAPSING. WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THE CATHETER WAS KINKED AND SOME OF THE COATING WAS PEELING UP. THE CATHETER WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10204356 ↗

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