LATITUDE® Communicator 6290 (UDI 00802526544224)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00802526544224), received between May 6, 2016 and May 9, 2023 — classified as 1 injury, 69 malfunctions.

The most frequently reported specific device problem is “Defective Device” (32 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR HAD A BURNING SMELL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR WAS DEACTIVATED. A RETURN LABEL WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894792 ↗
• MalfunctionApr 5, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR WAS DARK AND WAS EXTREMELY WARM TO TOUCH. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. THE COMMUNICATOR WAS DEACTIVATED. A RETURN LABEL WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16680668 ↗
• MalfunctionDec 8, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR FELT HOT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE RECOMMENDED TO CHECK THE COMMUNICATOR DURING THE NEXT VISIT IF IT WAS STILL HOT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939095 ↗
• MalfunctionOct 31, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED NO LIGHTS, AND THE COMMUNICATOR POWER CORD WAS EMITTING SPARKS. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED NOT TO CONTINUE TROUBLESHOOTING DUE TO SPARKING OF THE COMMUNICATOR POWER CORD. THE COMPANY REPRESENTATIVE ADVISED TO REPLACE THE COMMUNICATOR POWER CORD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698227 ↗
• MalfunctionSep 30, 2022Computer Operating System Problem; Power Problem; Computer Operating System Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT TRANSMITTING. THE METAL PART OF THE COMMUNICATOR POWER CORD THAT CONNECTS INTO THE OUTLET WAS OBSERVED TO BE MELTING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE COMMUNICATOR POWER CORD. THE COMMUNICATOR REMAINED IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522270 ↗
• MalfunctionSep 28, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR POPPED AND WAS NOT FUNCTIONING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND ADVISED TO REPLACE THE COMMUNICATOR AND COMMUNICATOR CELLULAR ADAPTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR WAS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501038 ↗
• MalfunctionSep 19, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR WAS FRIED AND NOT FUNCTIONING. THE PATIENT REPORTED A POWER OUTAGE. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. THE COMMUNICATOR WAS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445234 ↗
• MalfunctionSep 2, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT CONNECTING. THE PATIENT STATED THAT COMMUNICATOR SHOWED NO LIGHTS, AND A BURNING SMELL WAS EMANATING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT FOR COMMUNICATOR REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR WAS DEACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347087 ↗
• MalfunctionSep 1, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT LIGHTS WERE FLASHING AND SMOKE WAS COMING OUT OF THE COMMUNICATOR. THE PATIENT REPORTED THAT THE COMMUNICATOR SHOWED A RINGING SOUND. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. THE COMMUNICATOR WAS DEACTIVATED. A RETURN LABEL WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334470 ↗
• MalfunctionJul 20, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD IN THE WALL SOCKET EXPLODED AND BROKE APART. THE PATIENT REPORTED AN ELECTRONICAL STORM ABOUT A FEW DAYS AGO WHICH AFFECTED THE TELEVISION AND THE TELEPHONE LINE. THE COMMUNICATOR WAS NOT CONNECTING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED FOR A COMMUNICATOR REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR IS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064421 ↗
• MalfunctionJul 13, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER SUPPLY BRICK WAS UNUSUALLY WARM. THE COMMUNICATOR SHOWED NO LIGHTS OR POWER. THE COMMUNICATOR WAS NOT FUNCTIONING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999037 ↗
• MalfunctionJun 23, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR OVERHEATED AND CAUGHT ON FIRE DAMAGING THE NIGHTSTAND. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786534 ↗
• MalfunctionJun 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR WAS OBSERVED TO HAVE A BURNING SMELL AND WAS NOT FUNCTIONING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT ADVOCATE AND OPTED TO REPLACE THE ENTIRE SYSTEM. THE COMMUNICATOR WAS DEACTIVATED. A RETURN LABEL WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682683 ↗
• MalfunctionJun 3, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD MELTED, AND THE COMMUNICATOR WAS NOT POWERING UP. THE PATIENT REPORTED A BURNING SMELL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. A RETURN LABEL WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595219 ↗
• MalfunctionApr 20, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR STARTED SMOKING AND DIDN'T POWER UP ANYMORE. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT ADVOCATE FOR A COMMUNICATOR REPLACEMENT. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164179 ↗
• MalfunctionJan 22, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD WAS HOT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT THAT A REPLACEMENT POWER CORD WILL BE SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13327790 ↗
• MalfunctionJan 22, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD WAS BURNING AND MELTED. THE PATIENT ADVOCATE CALLED THAT ABOUT A MONTH AGO OR SO WOKE UP AND SMELLED SOMETHING BURNING. THE COMMUNICATOR POWER PLUG MELTED AND PRONGS INTO THE RECEPTACLE. THE PATIENT ADVOCATE HAD TO REPLACE THE SOCKET AND NEEDED PLIERS TO GET IT OUT. THE COMPANY REPRESENTATIVE OPTED TO REPLACE THE POWER CORD. THE COMMUNICATOR REMAINS IN SERVICE WHILE THE POWER CORD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13327509 ↗
• MalfunctionJan 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR SMELLS LIKE BURNT. FURTHERMORE, THE PATIENT WAS ADVISED TO CONTACT THE HOSPITAL FOR A NEW COMMUNICATOR. NO ADVERSE PATIENT EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13327505 ↗
• MalfunctionJan 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED A YELLOW CALL DOCTOR ICON AND SMELLED SMOKE COMING OUT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE COMMUNICATOR. A RETURN LABEL WAS SENT. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13327503 ↗
• MalfunctionJan 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR DISPLAYED YELLOW CALL DOCTOR ICON AND ALSO MENTIONED THAT IT MIGHT COME OUT THE SMELL OF SMOKE OF THE COMMUNICATOR. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENT EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13326954 ↗
• MalfunctionJan 22, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR BURNED DUE TO ELECTRIC MALFUNCTION. FURTHERMORE, THE COMMUNICATOR WAS REPLACED AND WILL BE RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13326926 ↗
• MalfunctionOct 28, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR BURNED OUT AFTER A STORM IN PATIENT NEIGHBORHOOD THEN FOLLOWED BY A POWER CUT. FURTHERMORE, THE COMMUNICATOR WAS REPLACED AND WILL BE RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716701 ↗
• MalfunctionJul 28, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT BURNING SMELL WAS COMING FROM THE COMMUNICATOR AND IT WAS VERY HOT. THE COMMUNICATOR WAS NOT FUNCTIONING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE ENTIRE SYSTEM. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243134 ↗
• MalfunctionJul 28, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT CALLED AS THE COMMUNICATOR IS FLASHING GREEN LIGHT AND SMELL OF HOT WIRES. THE COMPANY REPRESENTATIVE VERIFIED THAT THERE IS NO OTHER EQUIPMENT NEARBY. THE COMPANY REPRESENTATIVE OPTED TO SEND A NEW COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243128 ↗
• MalfunctionMay 6, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR AND POWER CORD HAD NO LIGHTS. FURTHERMORE, THE TRANSFORMER ON POWER CORD OVERHEATED AND MELTED. THE POWER CORD WILL BE RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11788351 ↗

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