EnSite™ Velocity NavLinkRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734209953), received between Jul 18, 2018 and Jul 20, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2020Output Problem; Output Problem

  DURING THE PROCEDURE, AN ERROR MESSAGE WAS DISPLAYED AND THE PROCEDURE WAS CANCELLED. AN ENSITE PRECISION ERROR MESSAGE APPEARED ON THE SCREEN AFTER VALIDATION: ¿NECK PATCH DISCONNECTED¿. TROUBLESHOOTING WAS PERFORMED WITH NO RESOLUTION. AF ABLATION COULD NOT BE COMPLETED AND ONLY A CTI ABLATION WAS PERFORMED. THE PATIENT WAS STABLE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296082 ↗
• InjuryJul 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ATRIAL FIBRILLATION AND ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE, THE NAVLINK PIN DETACHED WITHIN THE PATCH CONNECTOR AND MAPPING WAS NO LONGER POSSIBLE. THE AVNRT ABLATION WAS COMPLETED WITHOUT MAPPING, HOWEVER THE ATRIAL FIBRILLATION PORTION OF THE PROCEDURE WAS UNABLE TO BE COMPLETED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10220707 ↗
• InjuryNov 5, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ABLATION PROCEDURE, THE 3D NAVIGATION DID NOT FUNCTION AS EXPECTED. TROUBLESHOOTING WAS ATTEMPTED BY REPOSITIONING PATCHES, REVALIDATING, AND RESTARTING THE COMPUTER AND AMPLIFIER, WITH NO RESOLUTION. EXCHANING THE NAVLINK RESOLVED THE ISSUE AND THE PROCEDURE WAS CONTINUED WITH NO CONSEQUENCES TO THE PATIENT. THE LENGTH OF PROCEDURE WAS EXTENDED BY AN HOUR AND WAS CLINICALLY SIGNIFICANT DUE TO INCREASED HEPARIN ADMINISTRATION AND DIFFICULTIES IN MANAGING SEDATION FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279383 ↗
• InjuryAug 29, 2018Communication or Transmission Problem; Communication or Transmission Problem

  DURING DEVICE PREPARATION FOR A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AN ERROR MESSAGE APPEARED STATING THE NECK PATCH WAS DISCONNECTED AND THE PROCEDURE WAS CANCELLED. THE CONNECTIONS FOR THE NAVLINK AND PATCHES WERE VERIFIED AND APPEARED CORRECT. THE NECK AND CHEST PATCHES WERE REPLACED WITH NO RESOLUTION. A REPLACEMENT NAVLINK WAS UNAVAILABLE AND THE PROCEDURE WAS RESCHEDULED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7828765 ↗
• InjuryJul 18, 2018Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CANCELLATION OCCURRED DUE TO AN ERROR MESSAGE. FOLLOWING ANESTHESIA AND SHEATH INSERTION, THE SYSTEM REFERENCE PATCHES WERE PLACED ON THE PATIENT. THREE ERRORS WERE DISPLAYED UPON PATCH PLACEMENT AND COULD NOT BE RESOLVED EVEN AFTER THE PATCHES WERE EXCHANGED. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES ONTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7698177 ↗