Response™ 401353Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734200899), received between Jan 2, 2020 and May 7, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 7, 2022Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURING REF: 2030404-2022-00037. DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, INTERFERENCE WAS NOTED WHICH CAUSED A DELAY. SIGNAL INTERFERENCE WAS NOTED DURING THE PROCEDURE AND THE FOURTH ELECTRODE APPEARED DISTORTED IN THE SYSTEM. AFTER MULTIPLE ATTEMPTS OF CATHETER INTRODUCTION AND WITHDRAWAL, THE CATHETER STILL APPEARED DISTORTED IN THE SYSTEM. ANOTHER CATHETER WAS USED WHICH HAD THE SAME ISSUE. A THIRD CATHETER WAS USED TO CONTINUE THE PROCEDURE, HOWEVER THIS CAUSED A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319759 ↗
• MalfunctionMar 17, 2021Material Frayed; Material Frayed

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE, THE CATHETER WAS NOTED TO HAVE EXPOSED WIRING. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11502785 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT VENTRICULAR CRT-D IMPLANT PROCEDURE, A POSSIBLE CARDIAC PERFORATION OCCURRED. IT WAS NOT POSSIBLE TO CANNULATE THE CORONARY SINUS DUE TO THE PATIENT'S ANATOMY. A POSSIBLE PERFORATION WAS OBSERVED USING CONTRAST NEAR THE ORIFICE OF THE CORONARY SINUS AND THE PROCEDURE WAS STOPPED. THE PATIENT WAS IMPLANTED WITH A RIGHT ATRIAL AND RIGHT VENTRICULAR LEAD AND A LEFT VENTRICULAR LEAD WILL BE IMPLANTED AT A LATER DATE. THE PATIENT IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 10055647 ↗
• MalfunctionJan 2, 2020Break; Break

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURED CATHETER SHAFT WITH EXPOSED INTERNAL WIRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9540672 ↗

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