Response™ 401305Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734200752), received between Jun 15, 2018 and Jun 15, 2018 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2018-00175, 2030404-2018-00043, 3005334138-2018-00160, 3008452825-2018-00181, 3005334138-2018-00161. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED IN THE SUPERIOR SEPTAL LEFT ATRIUM. DURING GEOMETRY COLLECTION, THE LOWER RIGHT BRANCHES OF THE PULMONARY VEIN WERE DIFFICULT TO ENGAGE DUE A COMMON RIGHT PULMONARY OSTIUM. AFTER GEOMETRY WAS COLLECTED, AN ABLATION LINE ENCIRCLING THE RIGHT VEIN WAS ATTEMPTED AND THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND REVEALED AN EFFUSION IN THE SUPERIOR SEPTAL LEFT ATRIUM FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. FURTHER ABLATION WAS ABORTED. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7604675 ↗

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