Response™ 401210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734200486), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionApr 18, 2024Fracture; Difficult to Remove; Fracture; Difficult to Remove

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THE CONNECTION OF THE BLACK SHAFT OF THE ELECTRODE AND THE GRAY CURVED HEAD WAS FRACTURED ON THE DIAGNOSTIC CATHETER. THERE WAS RESISTANCE WHEN REMOVING THE CATHETER FROM THE SHEATH. THE CATHETER WAS NOT REINSERTED INTO THE PATIENT AGAIN AFTER THIS ISSUE WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131396 ↗

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