LATITUDE® Communicator 6280 (UDI 00802526577307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00802526577307), received between Jun 9, 2017 and Apr 17, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2024Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD HAS SHORTED OUT AND KEEPS TURNING ON AND OFF WHEN TOUCHED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED 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 19123762 ↗
• MalfunctionOct 3, 2023Defective Device; Power Problem; Defective Device; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT ABLE TO CONNECT AND HOT AND SMELLED LIKE SMOKE. THE PATIENT RECONNECTED THE COMMUNICATOR BUT WAS STILL THE SAME. THE COMMUNICATOR ISSUE WAS NOT RESOLVED. A NEW COMMUNICATOR AND A CELLULAR ADAPTER WERE SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR WAS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862464 ↗
• MalfunctionAug 28, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR SMELLED A BURNING PLASTIC SMELL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT ADVOCATE TO UNPLUG THE COMMUNICATOR AND TO PLUG INTO ANOTHER POWER OUTLET. THE PATIENT STILL OBSERVED A BURNING PLASTIC SMELL. 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 17638267 ↗
• MalfunctionMay 3, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE ELECTRICITY OUTLET BURNED UP THE COMMUNICATOR POWER CORD PRONG. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED SENDING A NEW COMMUNICATOR POWER CORD. THE COMMUNICATOR IS STILL IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859259 ↗
• MalfunctionOct 16, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER WAS OUT, AND THE COMMUNICATOR WAS SMOKING. THE PATIENT USING THE COMMUNICATOR REQUESTED FOR A COMMUNICATOR POWER CORD AND NOT A COMMUNICATOR CELLULAR ADAPTER. THE PATIENT TRIED TO USE A DIFFERENT POWER CORD FOR THE COMMUNICATOR. THE COMMUNICATOR STARTED SMOKING. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND ADVISED 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 15613127 ↗
• MalfunctionJul 28, 2021Inadequate User Interface; Inadequate User Interface

  IT WAS REPORTED THAT THE COMMUNICATOR SHOWED A YELLOW SENDING WAVE AND THE COMMUNICATOR CELLULAR ADAPTER WAS HOT TO TOUCH. THE COMMUNICATOR CELLULAR ADAPTER ALSO SHOWED NO LIGHTS. THE COMMUNICATOR CELLULAR ADAPTER WAS RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM PRODUCT INVESTIGATION INDICATES THAT THE ALLEGATION WAS CONFIRMED. THE RETURNED COMMUNICATOR CELLULAR ADAPTER WAS UNABLE TO BE UTILIZED BY A FUNCTIONAL COMMUNICATOR. NO LIGHT EMITTING DIODE (LED) LIGHT WAS PRESENT INDICATING THE DEVICE WAS NOT PROPERLY ABLE TO UTILIZE THE SUPPLIED POWER FROM THE COMMUNICATOR AND A HARDWARE ANOMALY EXISTS WITHIN THE CELLULAR ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243053 ↗
• MalfunctionOct 22, 2018Inadequate User Interface; Inadequate User Interface

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LIGHTNING HIT THE COMMUNICATOR AND THE COMMUNICATOR BLEW OUT THE PHONE LINES. THE CLINIC REQUESTED A RETURN LABEL TO BE SENT TO THE CLINIC. THE COMMUNICATOR IS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7989427 ↗
• MalfunctionOct 22, 2018Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR POWER CORD HAD AN ANOMALY. BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THE OUTLET PORTION OF THE COMMUNICATOR POWER CORD WAS BROKEN AND THE WIRE WAS OBSERVED TO BE BURNED. THE COMPANY REPRESENTATIVE VERIFIED THAT THERE WAS NO REPORTED DAMAGE TO ANY PROPERTY. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT FOR A POWER CORD REPLACEMENT. ADDITIONAL INFORMATION FROM THE PRODUCT ANALYSIS INDICATES THAT THE ALLEGATION AGAINST THE COMMUNICATOR POWER CORD WAS CONFIRMED. THE COMMUNICATOR POWER BRICK WAS BROKEN IN SEVERAL LOCATIONS. ADDITIONAL INFORMATION ALSO INDICATES THAT THERE WAS ZERO VOLTAGE UPON TESTING ON THE POWER CORD. THE COMMUNICATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7989215 ↗
• MalfunctionMar 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE POWER CORD HAD NO LIGHT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THE COMMUNICATOR WAS PLUGGED INTO A WORKING POWER OUTLET. THE POWER CORD WILL BE REPLACED AND A RETURN LABEL WILL BE SENT. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT ADVOCATE TO CALL BACK IF THE NEW POWER CORD WILL NOT FIX THE ISSUE. THE COMMUNICATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7368993 ↗
• MalfunctionOct 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE POWER CORD EXPLODED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THE PATIENT'S HOUSE WAS STRUCK BY LIGHTNING. THE COMPANY REPRESENTATIVE VERIFIED THAT THE REPLACEMENT COMMUNICATOR AND RETURN LABEL WILL BE SENT. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6933043 ↗
• MalfunctionJul 18, 2017Device Operates Differently Than Expected; Inadequate User Interface; Device Operates Differently Than Expected; Inadequate User Interface

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR WAS BURNT AND THE COMMUNICATOR ALSO AFFECTED THE INCOMING AND OUTGOING CALLS. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THERE WAS A LIGHTNING STORM THAT STRUCK BOTH THE COMMUNICATOR AND PHONE LINE AND THERE WAS A SPARK FROM THE AREA NEAR THE COMMUNICATOR WHERE IT WAS LIKELY COMING FROM THE OUTLET WHERE THE COMMUNICATOR WAS CONNECTED. THE PATIENT INFORMED THE COMPANY REPRESENTATIVE THAT NOBODY WAS INJURED AND THE PHONE LINES WERE EVENTUALLY RESTORED AFTER UNPLUGGING THE COMMUNICATOR.¿E COMPANY REPRESENTATIVE THEN SENT A RETURN LABEL, A REPLACEMENT COMMUNICATOR AND A LONGER PHONE CORD TO THE PATIENT. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6720707 ↗
• MalfunctionJun 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR WAS SMOKING AND WAS REPLACED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THAT A RETURN LABEL WILL BE SENT FOR THE COMMUNICATOR. THE COMMUNICATOR IS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629783 ↗

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