LATITUDE® Communicator 6476Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00802526516115), received between Jul 4, 2018 and Jan 26, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Power Problem” (3 reports).

10 other recalls cover devices cleared under the same FDA submission (P910077); 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR HAD BLOWN UP. THE PATIENT TOOK THE COMMUNICATOR TO THE DOCTOR'S OFFICE, AND THE COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586219 ↗
• MalfunctionSep 15, 2023Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT A LIGHTNING STORM HAS IMPACTED THE COMMUNICATOR ABOUT A WEEK AGO AND HAD A BURNING SMELL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE HAS OPTED TO SEND FOR THE COMMUNICATOR AND CELLULAR ADAPTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR IS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755820 ↗
• MalfunctionJan 16, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD GOT SO HOT. THE COMMUNICATOR BURNED UP AND STARTED TO SMOKE. THE PATIENT BROUGHT THE COMMUNICATOR TO CLINIC AND THE PATIENT WAS GIVEN A NEW ONE. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16173319 ↗
• MalfunctionFeb 6, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD WAS HOT, EMITTING SMOKE AND WAS SPARKING. THE COMMUNICATOR WAS FOR REPLACEMENT AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467430 ↗
• MalfunctionJul 16, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD SHORTED OUT AND NO LONGER HAD LIGHTS ON. THE PATIENT MENTIONED THAT THE POWER CORD SPARKED WHEN TRIED TO PLUG IN. DUE TO THE POTENTIAL DAMAGE, THE COMPANY REPRESENTATIVE ADVISED ABOUT THE PRODUCT RETURN AND REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10287057 ↗
• MalfunctionJun 18, 2019Energy Output Problem; Energy Output Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT REPORTED THAT THE COMMUNICATOR SMELLED LIKE BURNT WIRES AFTER THE LIGHTNING STRIKE NEAR HIS HOME. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT THAT A NEW COMMUNICATOR AND A CELLULAR ADAPTER WILL BE REPLACED. NO ADVERSE PATIENTS EFFECT REPORTED. THE COMMUNICATOR WAS DEACTIVATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707212 ↗
• MalfunctionJul 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR WAS SMOKING. COMMUNICATOR WAS DEACTIVATED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662649 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P910077. One submission often covers many models, so check the product and lot details in each record.

• Z-0673-2024 · Nov 30, 2023 · Open, Classified
  Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: AL
• Z-1216-2023 · Feb 2, 2023 · Open, Classified
  LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
• Z-1669-2022 · Jul 7, 2022 · Open, Classified
  The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The
• Z-3260-2018 · Sep 10, 2018 · Terminated
  Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communic
• Z-1445-2012 · Feb 24, 2012 · Terminated
  Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysi
• Z-1096-2012 · Dec 19, 2011 · Terminated
  LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transf
• Z-0333-2012 · Oct 12, 2011 · Terminated
  LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system
• Z-0037-2012 · Aug 12, 2011 · Terminated
  LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software ver
• Z-1631-2010 · Sep 10, 2009 · Terminated
  Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)
• Z-0002-2007 · May 19, 2006 · Terminated
  Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable p