LATITUDE® Communicator 6290 (UDI 00802526585609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00802526585609), received between Feb 9, 2017 and Aug 19, 2026 — classified as 1 injury, 141 malfunctions.

The most frequently reported specific device problem is “Power Problem” (95 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 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50319163 ↗
• MalfunctionAug 7, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50178362 ↗
• MalfunctionAug 7, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173032 ↗
• MalfunctionJul 14, 2026Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS HAVING POPS BREAKERS AT THE OUTLET. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. 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 25808848 ↗
• MalfunctionJun 19, 2026Application Program Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTED DEVICE RECORDED TWO VENTRICULAR EPISODES WITH TACHY THERAPY FROM (B)(6), HOWEVER, THE COMMUNICATOR ALERTS WERE NOT DETECTED BY THE CONSULT REPORT UPLOADED ON MAY 6. IT WAS NOTED THAT THESE STORED EPISODES WERE OF INTEREST BECAUSE OF A RECENT HOSPITALIZATION DUE TO HEART ATTACK. REVIEW OF TRANSMISSION DATA INDICATED THE COMMUNICATOR ALERTS WERE NOT POSTED UNTIL MAY 21, DUE TO CELLULAR CONNECTION ISSUES. THIS COMMUNICATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562167 ↗
• MalfunctionJun 9, 2026Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS STOPPED WORKING AFTER THE POWER ADAPTER OVERHEATED. THE PATIENT NOTICED A BURNING SMELL AND HEAT, AND THE ADAPTER PRONGS APPEARED TO MELT INTO THE WALL OUTLET, DAMAGING IT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. AN ELECTRICIAN REPLACED THE OUTLET AND WIRING WAS UNAFFECTED. THERE WERE NO STORMS OR OUTAGES OBSERVED. NO INJURIES REPORTED. 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 25446938 ↗
• MalfunctionMay 28, 2026Communication or Transmission Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD AND CELLULAR ADAPTER WAS FRAYING AND SPLITTING POWER CORD WHICH EVENTUALLY CAUSED SPARKED. THE COMMUNICATOR WAS NOT CONNECTING. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. 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 25322672 ↗
• MalfunctionApr 30, 2026Computer Operating System Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED A FLASHING YELLOW CALL DOCTOR ICON (YCD). THE COMMUNICATOR AND POWER CORD WAS GETTING HOT. THERE WERE NO STORMS OR POWER OUTAGES REPORTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045390 ↗
• MalfunctionApr 29, 2026Communication or Transmission Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT CONNECTING AND WAS SHOWING YELLOW SENDING WAVE (YSW). THE COMMUNICATOR LIGHTS WERE BURNED OUT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. THE COMMUNICATOR WAS OPTIMIZED FOR PLACEMENT OF THE UNIVERSAL SERIAL BUS (USB) ADAPTER TO ANOTHER PORT. A COMMUNICATOR FORCE CALL WAS PERFORMED WHICH FOUND YELLOW SENDING WAVE. THE COMMUNICATOR STATUS BUTTON WAS SHOWING YELLOW SENDING WAVE. 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 25029688 ↗
• MalfunctionApr 28, 2026Communication or Transmission Problem; Computer Operating System Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT CONNECTING AND WAS FLASHING YELLOW CALL DOCTOR ICON (YCD). THE COMMUNICATOR POWER CORD TIP ENDS EXHIBITED HOT TO TOUCH. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. 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 25023835 ↗
• MalfunctionMar 25, 2026Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED NO LIGHTS AND SMELLED BURNING. A COMMUNICATOR POWER CYCLE WAS PERFORMED. THE PATIENT WAS UNSURE IF THE ISSUE WAS THE COMMUNICATOR OR POWER CORD. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR AND THE CELLULAR ADAPTER. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684108 ↗
• MalfunctionMar 23, 2026Communication or Transmission Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD WAS OBSERVED TO BE BURNING IN THE ELECTRICAL OUTLET. THE COMMUNICATOR POWER CORD BECAME SWOLLEN, HOT, MELTED. AND WAS LOOSE. THE COMMUNICATOR WAS NOT CONNECTING. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. 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 24662377 ↗
• MalfunctionMar 17, 2026Computer Operating System Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED A FLASHING YELLOW CALL DOCTOR ICON (YCD), AND THE COMMUNICATOR POWER CORD WAS HOT AND MELTING. THE COMMUNICATOR OCCASIONALLY FLASHED A YELLOW CALL DOCTOR ICON (YCD), THEN WENT OFF AND CAME ON AT TIMES. THE POWER CORD LIGHT ALSO STARTS FLASHING AND THEN GOES OFF. THE PATIENT NOTICED THAT THERE WAS A BROKEN WIRE ON THE POWER CORD, AND IT WAS HOT AND MELTING. THERE WAS SMOKE COMING FROM THE BROKEN WIRE AREA. THE PATIENT SAFELY UNPLUGGED THE POWER BRICK. THERE WERE STORMS OR POWER OUTAGES REPORTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618774 ↗
• MalfunctionMar 13, 2026Computer Operating System Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS SHOWING YELLOW CALL DOCTOR ICON, AND THE COMMUNICATOR POWER CORD FELT HOT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE PERFORMED THE TROUBLESHOOTING AND DISCUSSED WITH THE PATIENT ADVOCATE 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 24597630 ↗
• MalfunctionMar 6, 2026Power Problem

  IT WAS REPORTED THAT THERE WERE NO LIGHTS ON THE COMMUNICATOR AND IT SMELLED BURNING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE PERFORMED THE TROUBLESHOOTING AND 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 24530942 ↗
• MalfunctionFeb 23, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS SHOWING YELLOW SENDING WAVES AND WAS NOT CONNECTING. THE PATIENT ADVOCATE MENTIONED THAT ONE OF THE OF THE UNIVERSAL SERIAL BUS (USB) PORTS LOOKED BURNED AND DARKER THAN THE OTHER PORT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE PERFORMED THE TROUBLESHOOTING AND DISCUSSED WITH THE PATIENT ADVOCATE 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 24413293 ↗
• MalfunctionFeb 12, 2026Computer Operating System Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SMELLS LIKE BURNING. THE PATIENT WAS ADVISED TO KEEP THE COMMUNICATOR DISCONNECTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE BOTH THE COMMUNICATOR AND THE CELLULAR ADAPTER. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319877 ↗
• MalfunctionJan 27, 2026Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD MELTED. THE POWER BRICK WAS HOT WHICH CAUSES FOR THE POWER CORD TO MELT. THE POWER INDICATOR LIGHT WAS ON, AND THE POWER SUPPLY CORD IS NOT LUMINATED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188705 ↗
• MalfunctionJan 26, 2026Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER OUTLET STARTED THE FIRE WITH THE COMMUNICATOR. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176634 ↗
• MalfunctionJan 22, 2026Computer Operating System Problem

  IT WAS REPORTED THAT THE COMMUNICATOR LOOKS BURNT. THE PATIENT WAS ADVISED TO UNPLUG THE COMMUNICATOR. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157646 ↗
• MalfunctionJan 15, 2026Computer Operating System Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED A YELLOW CALL DOCTOR ICON (YCD). THE PATIENT SMELLED SOMETHING BURNING. THERE WERE NO STORMS OR POWER OUTAGES REPORTED. THE PATIENT UNPLUGS THE COMMUNICATOR. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079399 ↗
• MalfunctionJan 9, 2026Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD MELTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031363 ↗
• MalfunctionDec 29, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD WAS SPARKING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED TO REPLACE THE COMMUNICATOR AND THE COMMUNICATOR POWER CORD. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907848 ↗
• MalfunctionDec 18, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD WAS GETTING HOT. THE COMMUNICATOR WAS EXCESSIVELY REBOOTING. THERE WERE NO STORMS OR POWER OUTAGES REPORTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838075 ↗
• MalfunctionDec 16, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER SUPPLY BRICK WAS DAMAGED, MELTED AND BURNED AT THE END OF THE PLUG THAT GOES INTO THE WALL. THE PATIENT SAID POSSIBLE REASON WAS DUE TO THE WALL OF POWER OUTLET OF THE APARTMENT THAT WAS NOT FUNCTIONING PROPERLY. THE PATIENT WAS ABLE TO SAFELY REMOVE THE POWER SUPPLY BRICK FROM THE WALL. THERE WERE NO STORMS OR OUTAGES REPORTED. THE PATIENT WAS GOING TO PLUG THE NEW COMMUNICATOR INTO A DIFFERENT POWER OUTLET IN THE APARTMENT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED TO SEND THE COMMUNICATOR. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824470 ↗

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