LATITUDE® Communicator 6498Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00802526554704), received between Jun 13, 2017 and Jul 28, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 28, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED NO LIGHTS AND SPARKED. THE COMMUNICATOR WAS POWER CYCLED BUT STILL NO LIGHTS. THE PATIENT ADVOCATE TRIED ANOTHER OUTLET BUT NO LIGHT ON COMMUNICATOR AND COMMUNICATOR POWER CORD. THE PATIENT ADVOCATE INFORMED THAT THE PATIENT SAW SPARKS COMING FROM THE COMMUNICATOR. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED SENDING A REPLACEMENT COMMUNICATOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR WAS DEACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127285 ↗
• MalfunctionJan 22, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR PLUG WAS GETTING OVER HEATED AND CRACKED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT TO REPLACE THE COMMUNICATOR. A RETURN LABEL WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 11218877 ↗
• MalfunctionApr 26, 2019Power Problem; Power Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT ADVOCATE CALLED AS THE PATIENT BUMPED INTO THE TABLE AND THE POWER CORD EXPLODED. THE POWER CORD WAS IN AN OUTLET WITH A QUESADILLA MAKER AND WAFFLE MAKER. THE BACK OF THE COMMUNICATOR WAS RUINED. THERE WAS NO PROPERTY DAMAGE, AND NO ONE WAS HURT DUE TO THE EVENT. THE COMPANY REPRESENTATIVE VERIFIED THERE WERE NO POWER OUTAGE OR ELECTRICAL STORM AND AN ORIGINAL POWER SUPPLY WAS USED. THE COMMUNICATOR WAS CURRENTLY UNPLUGGED. THE COMPANY REPRESENTATIVE ADVISED FOR A COMMUNICATOR REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554631 ↗
• MalfunctionOct 22, 2018Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RECENT LIGHTNING STORM TOOK OUT THE COMMUNICATOR. THE CORD GOES INTO THE BACK OF THE COMMUNICATOR WAS MELTED. NO POWER GOING TO THE COMMUNICATOR. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR AND A RETURN LABEL WAS SENT. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7989424 ↗
• MalfunctionJun 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE POWER CORD HAD A POPPING SOUND AND EMITTED SPARKS WHEN THE PATIENT ATTEMPTED TO SET UP THE COMMUNICATOR. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THE PATIENT ADVOCATE CLAIMED THAT THE COMMUNICATOR WAS EMITTING SMOKE. FURTHERMORE, THE COMPANY REPRESENTATIVE ADVISED THAT A NEW COMMUNICATOR AND A RETURN LABEL WILL BE SENT. THE COMMUNICATOR WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6638229 ↗

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