LATITUDE® Communicator 6280 (UDI 00802526544118)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00802526544118), received between May 6, 2016 and Dec 27, 2024 — classified as 3 malfunctions.

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

• MalfunctionDec 27, 2024Defective Device; Power Problem; Defective Device; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS FLASHING YELLOW CALL DOCTOR ICON (YCD. THE COMMUNICATOR POWER CORD WAS NOT POWER ON AND INSIDE OF THE COMMUNICATOR EXHIBITED HOT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. THERE WERE NO STORMS OR OUTAGES OBSERVED. THE COMMUNICATOR ISSUE PERSISTED. THE COMPANY REPRESENTATIVE ADVISED TO REPLACE 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 21031031 ↗
• MalfunctionJul 12, 2023Connection Problem; Power Problem; Connection Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD HAD A SHORT AND THE COMMUNICATOR WAS NOT CONNECTING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR POWER CORD AND THE FOURTH-GENERATION COMMUNICATOR CELLULAR ADAPTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305179 ↗
• MalfunctionMay 6, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR POWER CORD WAS MELTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED NO ONE WAS INJURED. THE COMPANY REPRESENTATIVE OFFERED TO REPLACE THE POWER CORD BUT THE PATIENT DOES NOT WANT TO USE THE COMMUNICATOR ANYMORE. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT TO CALL THE PHYSICIAN IN REGARDS OF THE COMMUNICATOR USAGE. A RETURN LABEL WILL BE SEND WITH THE POWER CORD. THE COMMUNICATOR WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5636545 ↗

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