Response™ 401227Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734200561), received between Apr 19, 2019 and Jan 15, 2020 — classified as 2 deaths, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2020-00015, 3008452825-2020-00016, 3008452825-2020-00017, 3008452825-2020-00018, 3005334138-2020-00020, 3005334138-2020-00021. DURING THE MAPPING OF A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, FOLLOWING MAPPING OF THE RIGHT AND LEFT VENTRICLE, THE PATIENT EXPERIENCED RESPIRATORY FAILURE AND PULSELESS ELECTRICAL ACTIVITY. AN IMMEDIATE CARDIAC MASSAGE WAS PERFORMED, WITHOUT THE RESTORATION OF NATURAL HEART CONTRACTION. THERE WAS NO PERICARDIAL EFFUSION VISIBLE WITH THE INTRACARDIAC ECHO AND THE PROCEDURE WAS INTERRUPTED BEFORE THE ABLATION. THE PATIENT EXPIRED. THE CAUSE OF THE RESPIRATORY FAILURE AND SUBSEQUENT DEATH IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Arrhythmia; Death; Respiratory Failure

  MAUDE report 9590533 ↗
• DeathJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2020-00015, 3005334138-2020-00019, 3008452825-2020-00016, 3008452825-2020-00017, 3008452825-2020-00019, 3005334138-2020-00020, 3005334138-2020-00021. DURING THE MAPPING OF A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, FOLLOWING MAPPING OF THE RIGHT AND LEFT VENTRICLE, THE PATIENT EXPERIENCED RESPIRATORY FAILURE AND PULSELESS ELECTRICAL ACTIVITY. AN IMMEDIATE CARDIAC MASSAGE WAS PERFORMED, WITHOUT THE RESTORATION OF NATURAL HEART CONTRACTION. THERE WAS NO PERICARDIAL EFFUSION VISIBLE WITH THE INTRACARDIAC ECHO AND THE PROCEDURE WAS INTERRUPTED BEFORE THE ABLATION. THE PATIENT EXPIRED. THE CAUSE OF THE RESPIRATORY FAILURE AND SUBSEQUENT DEATH IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Arrhythmia; Death; Respiratory Failure

  MAUDE report 9590527 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00217, 3008452825-2019-00190, 3008452825-2019-00192, 3008452825-2019-00193, 3008452825-2019-00194, 3005334138-2019-00218, 3005334138-2019-00219. DURING A VENTRICULAR TACHYCARDIA PROCEDURE, A CARDIAC TAMPONADE OCCURRED. SEVERAL MINUTES AFTER ABLATING THE RIGHT VENTRICLE, THE PATIENT BECAME HYPOTENSIVE. TRANSESOPHAGEAL ECHOGRAPHY REVEALED A TAMPONADE. A THORACOTOMY WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8533260 ↗

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