Response™ 401261Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734200592), received between Dec 21, 2018 and Sep 8, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. THE RIGHT ATRIAL TACHYCARDIA WAS INDUCED AND THE HD GRID WAS USED TO MAP THE RIGHT ATRIUM AND THE ABLATION CATHETER WAS USED TO ABLATE. THE ABLATION WAS JUST ABOVE THE SINUS NODE ON THE POSTERIOR LATERAL RIGHT ATRIUM. THE TACHYCARDIA COULD NO LONGER BE INDUCED SO THE STUDY WAS ENDED. FOLLOWING ANESTHESIA, PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND WAS USED TO CONFIRM A PERICARDIAL EFFUSION IN THE RIGHT VENTRICLE. THE FLUID WAS REMOVED AND A DRAIN WAS PLACED. THE PATIENT WAS STABLE. THE PHYSICIAN STATED THAT HE DOES NOT KNOW WHAT CAUSED THE EFFUSION BUT THAT IS WAS MORE LIKELY THE RVA CATHETER THAN THE ABLATION CATHETER AS IT WAS A SMALL BLEED.

  Patient problems: Cardiac Perforation

  MAUDE report 15381236 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA ABLATION PROCEDURE, A PERFORATION WAS NOTED VIA ECHOCARDIOGRAM. DURING THE PROCEDURE, THE RIGHT VENTRICULAR CATHETER STOPPED CAPTURING WHEN ATTEMPTING TO PACE AND THERE WAS NO EGM SIGNAL ON THE DISTAL ELECTRODE. THE PATIENT THEN BECAME HYPOTENSIVE AND THE PHYSICIAN CONFIRMED A PERFORATION VIA ECHOCARDIOGRAM. NO INTERVENTION WAS ADMINISTERED AND THE PROCEDURE WAS COMPLETED ONCE THE PATIENT'S BLOOD PRESSURE RETURNED BACK TO NORMAL. THE PATIENT WAS KEPT FOR OBSERVATION AND WAS DISCHARGED IN A STABLE CONDITION THE FOLLOWING DAY. THE PHYSICIAN BELIEVED THE RIGHT VENTRICULAR CATHETER CAUSED THE PERFORATION. THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 12761783 ↗
• MalfunctionDec 21, 2018Fracture; Fracture

  FOLLOWING AN ATRIOVENTRICULAR NODEL REENTRY TACHYCARDIA PROCEDURE, THE OUTER MATERIAL OF THE CATHETER WAS DAMAGED, EXPOSING THE INTERNAL WIRES AFTER REMOVING THE CATHETER FROM THE PATIENT. NO DIFFICULTY WAS NOTED INSERTING OR WITHDRAWING THE CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191587 ↗

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