Response™ 401223Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734200523), received between Jun 16, 2025 and Jun 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, THE DIAGNOSTIC CATHETER FRACTURED WHILE IN THE RIGHT ATRIUM. IT WAS NOT MANEUVERING PROPERLY AND SO THE CATHETER WAS REMOVED. THE CATHETER WAS BENT AND SEPARATED AT THE BOUNDARY BETWEEN THE BLACK AND GREY PORTION OF THE CATHETER WHERE THE SHAFT AND DISTAL ELECTRODE TRANSITION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216556 ↗

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