Response™ 401226Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734200554), received between Jun 19, 2023 and Jun 19, 2023 — classified as 1 death.

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.

• DeathJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS. A TRANSSEPTAL PUNCTURE WAS PERFORMED, BUT NO EFFUSION WAS SEEN ON ECHOGRAPHY DURING OR AFTER THE TRANSSEPTAL PUNCTURE. DURING RF LESIONS ON THE SEPTUM/ANTERIOR LEFT VENTRICLE, THE PATIENT WAS STABLE. THE PATIENT BECAME HYPOTENSIVE AT THE END OF THE PROCEDURE, WHEN CATHETERS WERE REMOVED FROM THE RIGHT VENTRICLE. AN ECHOGRAPHY REVEALED A PERICARDIAL EFFUSION AT THE RIGHT VENTRICULAR APEX AND AROUND 880 ML OF BLOOD WAS DRAINED FROM THE PERICARDIUM WITHOUT BLOOD RE-INJECTION. THE PROCEDURE WAS THEN COMPLETED. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IT IS ALLEGED THAT THE EFFUSION WAS DUE TO THE RESPONSE ELECTROPHYSIOLOGY QUADRIPOLAR CATHETER IN THE RIGHT VENTRICLE BECAUSE THE PATIENT BECAME HYPOTENSIVE WHEN THE CATHETER WAS REMOVED AND BECAUSE THE COLOR OF THE BLOOD REMOVED WITH THE DRAINAGE WAS BLOOD POOR IN OXYGEN. THE PROCEDURE WAS COMPLETED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. IT WAS NOTED THAT THE PATIENT DIED 1-2 DAYS AFTER THIS PROCEDURE DUE TO HEART FAILURE, SPECIFICALLY VENTRICULAR FIBRILLATION. THE PHYSICIAN

  Patient problems: Cardiac Perforation

  MAUDE report 17160048 ↗

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