Response™ 401222Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734200516), received between Jul 30, 2024 and Jul 30, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH INDUCED AV NODAL REENTRANT TACHYCARDIA AND ATRIAL FLUTTER, A PERICARDIAL EFFUSION OCCURRED, REQUIRING A PERICARDIOCENTESIS. THE PHYSICIAN ALLEGES THAT THE PERICARDIAL EFFUSION WAS CAUSED BY THE RV RESPONSE JSN CATHETER DURING THE EP STUDY USING ISOPRENALINE. POST PROCEDURE THE PATIENT WAS BRADYCARDIC AND HYPOTENSIVE WHILE GROIN PRESSURE WAS BEING APPLIED. AN ULTRASOUND WAS PERFORMED, AND A PERICARDIAL EFFUSION WAS NOTED. IT WAS ASSUMED TO BE LOCATED IN THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE THE ADVERSE EVENT WAS RELATED TO THE ABLATION CATHETER.

  Patient problems: Cardiac Perforation

  MAUDE report 19867347 ↗

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