LATITUDE® Communicator 6290 (UDI 00802526577451)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00802526577451), received between May 6, 2016 and Oct 3, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Defective Device; Power Problem; Defective Device; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS FLASHING A YELLOW CALL DOCTOR ICON, AND THE COMMUNICATOR POWER CORD WAS HOT WHEN UNPLUGGING FROM THE COMMUNICATOR. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE PATIENT IN TROUBLESHOOTING. THERE WERE NO STORMS OR POWER OUTAGES OBSERVED. A COMMUNICATOR POWER CYCLE WAS PERFORMED. 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 20359511 ↗
• MalfunctionAug 6, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR SMELLS LIKE SOMETHING WAS BURNING WHEN PLUGGED IN. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT TO UNPLUG THE COMMUNICATOR. THE COMMUNICATOR ISSUE WAS NOT RESOLVED. A NEW COMMUNICATOR AND A RETURN LABEL WERE SENT. NO ADVERSE PATIENT EFFECTS REPORTED. THE COMMUNICATOR WAS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467253 ↗
• MalfunctionJun 27, 2023Defective Device; Power Problem; Defective Device; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS DARK AND WAS OBSERVED TO HAVE A BURNED SMELL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT TROUBLESHOOTING STEPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR WAS NO LONGER IN SERVICE. ADDITIONAL INFORMATION FROM PRODUCT INVESTIGATION INDICATES THAT THE COMMUNICATOR ALLEGATION WAS CONFIRMED. PRODUCT ANALYSIS SHOWED THAT A BURNING SMELL WAS OBSERVED, AND CHARRED MARKS CAN BE FOUND IN THE ELECTRICAL COMPONENT. THE COMMUNICATOR BEHAVIOR WAS CONSISTENT WITH A HIGH-POWER ELECTRICAL OVERSTRESS EVENT. THE DAMAGE OBSERVED TO COMMUNICATOR HAS BEEN IDENTIFIED AS ELECTRICAL OVERSTRESS EVENT DAMAGE ATTRIBUTED BY THE ENVIRONMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17211496 ↗
• MalfunctionJan 5, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR WAS NOT WORKING AND HAD NO LIGHTS. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THERE WAS A RECENT ELECTRICAL OUTAGE AND ALSO VERIFIED THAT THE POWER CORD HAS A STEADY LIGHT. THE PATIENT OBSERVED THAT THERE WAS A BURNING SMELL AND THE COMMUNICATOR WAS WARM TO THE TOUCH. THE COMPANY REPRESENTATIVE HAD THE PATIENT UNPLUGGED THE POWER CORD FROM THE POWER OUTLET. THE COMPANY REPRESENTATIVE THEN ORDERED A COMMUNICATOR REPLACEMENT AND A RETURN LABEL WAS SENT. FURTHERMORE, THE COMPANY REPRESENTATIVE VERIFIED THAT THE PATIENT HAD A NEW ADDRESS. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7168660 ↗
• MalfunctionSep 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE POWER CORD SMELLS LIKE BURN AND THE LIGHTS WERE FLASHING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THERE WAS NO POWER OUTAGE OR ELECTRICAL STORM ASSOCIATED. THE COMPANY REPRESENTATIVE ALSO VERIFIED THAT THE PATIENT WAS USING THE ORIGINAL POWER SUPPLY. FURTHERMORE, THE COMPANY REPRESENTATIVE ADVISED THAT A NEW COMMUNICATOR AND POWER SUPPLY WILL BE REPLACED. A RETURN LABEL WAS SENT. THE COMMUNICATOR WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864232 ↗
• MalfunctionJun 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR'S ORIGINAL POWER CORD EMITTED A SMOKE. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT NO ONE WAS HURT AND CONFIRMED THAT THE PATIENT ATTEMPTED TO SET UP THE COMMUNICATOR BUT WAS UNSUCCESSFUL. THE COMPANY REPRESENTATIVE THEN SENT A NEW POWER CORD TO THE PATIENT AND ADVISED TO CALL BACK FOR SET UP ASSISTANCE. THE COMMUNICATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6680652 ↗
• MalfunctionJan 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR HAD NO LIGHTS. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE WAS INFORMED THAT THE COMMUNICATOR WAS PLUGGED INTO POWER. THE PATIENT ALSO NOTED THAT THE POWER SUPPLY WAS VERY WARM TO TOUCH AND WAS BROKEN. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT TO UNPLUG THE POWER CORD. THE POWER CORD WAS REPLACED. A RETURN LABEL WAS SENT TO THE PATIENT ADDRESS. THE COMMUNICATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6283352 ↗
• MalfunctionMay 6, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE POWER CORD MELTED IN THE SOCKET. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE PROVIDED ASSISTANCE AND OPTED FOR A POWER CORD ADAPTER REPLACEMENT. THE COMMUNICATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5636546 ↗

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