LATITUDE® Communicator 6290 (UDI 00802526570322)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00802526570322), received between Aug 3, 2016 and May 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE COMMUNICATOR UNIVERSAL SERIAL BUS (USB) ETHERNET ADAPTER WAS GETTING WARM AND THE PLASTIC ON IT WAS STARTING TO MELT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. THE PATIENT WAS ADVISED TO IMMEDIATELY REMOVE THE UNIVERSAL SERIAL BUS (USB) ADAPTER AND WAIT FOR THE REPLACEMENT. THE COMMUNICATOR ISSUE PERSISTED. THE COMPANY REPRESENTATIVE ADVISED REPLACING THE COMMUNICATOR. THE COMMUNICATOR WAS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322677 ↗
• MalfunctionMay 25, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED NO POWER AND WAS OBSERVED TO SMELL SMOKE. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR WAS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001229 ↗
• MalfunctionJan 12, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR'S POWER CORD WAS MELTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THE PATIENT WAS NOT SURE IF THE CAUSE WAS THE ELECTRICAL OUTLET. THE COMPANY REPRESENTATIVE VERIFIED THAT THERE WAS NO FIRE OR INJURY THAT OCCURRED. AN ELECTRICIAN CAME OUT AND REPLACED THE POWER OUTLET. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT THAT THE COMMUNICATOR WILL BE REPLACED AND ABOUT THE RETURN PROCESS. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185518 ↗
• MalfunctionJan 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR WAS EMITTING SMOKE. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE INSTRUCTED TO UNPLUG THE POWER CORD AND THE COMMUNICATOR WAS NO LONGER WORKING. THE COMPANY REPRESENTATIVE OPTED FOR A COMMUNICATOR REPLACEMENT AND A RETURN LABEL WILL BE SENT. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6283353 ↗
• MalfunctionJan 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR SHOWED A POWER ANOMALY. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THERE WAS A SPARK ON THE COMMUNICATOR. THE COMPANY REPRESENTATIVE ADVISED THE FIELD REPRESENTATIVE THAT A NEW COMMUNICATOR WILL BE SENT. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6267079 ↗
• MalfunctionAug 3, 2016Computer Operating System Problem; Inadequate User Interface; Computer Operating System Problem; Inadequate User Interface

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE ESTIMATED LONGEVITY FOR THE DEVICE DECREASED MORE QUICKLY THAN EXPECTED. ANALYSIS OF DEVICE DATA REVEALED THAT HIGHER POWER CONSUMPTION PERIODS CORRELATED WITH RADIO FREQUENCY (RF) OVERUSE, WHICH INDICATES THAT THE DEVICE USED MORE TIME THAN EXPECTED TO COMMUNICATE WITH THE COMMUNICATOR. THE PATIENT WAS CONTACTED TO DISCUSS METHODS TO MINIMIZE RF INTERFERENCE. THIS COMMUNICATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5844743 ↗

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