LATITUDE® Communicator 6280 (UDI 00802526570209)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00802526570209), received between May 6, 2016 and Jul 10, 2023 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Power Problem” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR CONTINUALLY REBOOTS, AND THE COMMUNICATOR POWER CORD HAD A SHORT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE PERFORMED TROUBLESHOOTING WITH THE COMMUNICATOR CONNECTION, AND THE COMMUNICATOR WAS ABLE TO CONNECT AND UPDATE FIRMWARE. THE PATIENT HAD TO HOLD THE COMMUNICATOR IN HER HANDS AND HAD TO CAREFULLY PLACE THE COMMUNICATOR BACK DOWN TO AVOID A REBOOT. THE COMPANY REPRESENTATIVE OPTED TO REPLACE THE POWER CORD AND CELLULAR ADAPTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286343 ↗
• InjuryMay 30, 2023Power Problem; No Apparent Adverse Event; Power Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WITH THIS COMMUNICATOR WAS IN THEIR BED WHEN THEY NOTICED TWO WIRES FROM THE COMMUNICATOR WERE IN CONTACT WITH THEIR METAL BED FRAME WHICH RESULTED IN THEIR HEATING PAD SHORTING OUT. DUE TO THIS, THE PATIENT RECEIVED AN ELECTRIC SHOCK WHICH THREW THEM OUT OF THEIR BED AND LED TO HURTING THEIR HIP. PATIENT FOUND THE SOURCE AND DISCONNECTED THE WIRES. THE PATIENT REACHED OUT TO BOSTON SCIENTIFIC TECHNICAL SERVICES AND REPLACEMENT OF THE COMMUNICATOR WAS ADVISED. THE PATIENT WAS MAILED A NEW COMMUNICATOR. THIS DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; Pain

  MAUDE report 17018522 ↗
• MalfunctionMay 5, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD STARTED TO SMOKE. 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 16875128 ↗
• MalfunctionOct 11, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT CONNECTING AND EMITTED SMOKE. THE PATIENT TRIED TO FIND THE COMMUNICATOR POWER CORD. THE PATIENT USING THE COMMUNICATOR, PLUGGED-IN A DIFFERENT POWER CORD. THE PATIENT SMELLED SMOKE COMING OUT FROM THE COMMUNICATOR. 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 15579121 ↗
• MalfunctionSep 27, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT WORKING. THE COMMUNICATOR LIGHTS TURNED ON AND OFF. THE PATIENT UNPLUGGED THE COMMUNICATOR POWER CORD BUT WAS HOT TO THE TOUCH. THE PATIENT DID NOT CONNECT THE COMMUNICATOR SINCE THEN. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE OPTED FOR A COMMUNICATOR POWER CORD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR REMAINS IN SERVICE WHILE THE POWER CORD WILL BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15490944 ↗
• MalfunctionJul 5, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR WAS PLUGGED TO A DIFFERENT POWER OUTLET. THE PATIENT SAW SPARKS COME OUT OF THE COMMUNICATOR. 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 14913770 ↗
• MalfunctionJan 22, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR WAS DARK AND EMITTED A BURNING SMELL WHEN PLUG INTO A POWER SOURCE.THE COMPANY REPRESENTATIVE ADVISED THE PATIENT ADVOCATE THAT A NEW COMMUNICATOR AND A CELLULAR ADAPTER WILL BE SENT.THE COMMUNICATOR WAS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13327501 ↗
• MalfunctionJan 22, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD CAUGHT ON FIRE. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED THAT THE PATIENT NEEDS TO CALL IN AND EXPLAIN THE EVENT. THE HEALTH CARE PROFESSIONAL (HCP) ORDERED A NEW COMMUNICATOR BUT MAY CALL BACK TO CANCEL AS THE PATIENT WAS SCHEDULED FOR A CHANGE-OUT. THE COMMUNICATOR POWER CORD WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR POWER CORD WAS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13327498 ↗
• MalfunctionOct 28, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THIS PATIENT HAD A REMOTE MONITOR TRANSMISSION TODAY; HOWEVER, ON TWO DIFFERENT OCCASIONS, THERE WAS NO ALERT TRANSMISSIONS FOLLOWING THE ANTI-TACHYCARDIA PACING (ATP) EPISODES. TECHNICAL SERVICES (TS) ASKED CLINICIAN IF THE PATIENT HAD BEEN AWAY FROM THEIR COMMUNICATOR DURING THIS TIME. THE CLINICIAN WILL CALL THE PATIENT TO INVESTIGATE FURTHER. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE CLARIFYING INFORMATION ABOUT THE PATIENT'S PROXIMITY DURING THE TIMEFRAME DISCUSSED, TO NO AVAIL. REMOTE MONITOR RECORDS INDICATE THE DEVICE AND COMMUNICATOR ARE WORKING WITHOUT INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMMUNICATOR REMAINS IN SERVICE.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716705 ↗
• MalfunctionFeb 23, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR EXHIBITED A BURNING SMELL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT TO REPLACE THE COMMUNICATOR. A RETURN LABEL WAS SENT FOR THE COMMUNICATOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11369571 ↗
• MalfunctionJan 15, 2021Defective Device

  IT WAS REPORTED THAT THE COMMUNICATOR WAS NOT WORKING, AND THE COMMUNICATOR POWER CORD WAS HOT. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND ADVISED FOR COMMUNICATOR REPLACEMENT. THE COMMUNICATOR WAS NO LONGER IN SERVICE. A COMMUNICATOR RETURN LABEL WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11180493 ↗
• MalfunctionJul 15, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS PAINTING AND A SMOKE IS COMING OUT OF THE COMMUNICATOR AND THE POWER ADAPTER. 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 Known Impact Or Consequence To Patient

  MAUDE report 10279604 ↗
• MalfunctionJul 15, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR POWER CORD WAS GETTING HOT AND EMITTING A BURNING SMELL. THE PATIENT ALSO OBSERVED THAT THE WALL OUTLET CORD FLICKERS POWER ON THE COMMUNICATOR. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ADVISED THE PATIENT TO REPLACE THE COMMUNICATOR POWER CORD. A RETURN LABEL WAS SENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT INVESTIGATION INDICATES THAT THE COMMUNICATOR POWER ADAPTER ALLEGATION WAS NOT CONFIRMED. THE COMMUNICATOR WAS RETURNED FOR ANALYSIS AS THE POWER ADAPTER IS SUPPLYING POWER TO COMMUNICATOR OVER SEVERAL MINUTES DURING THE BASELINE CHECKS. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE COMMUNICATOR AND POWER ADAPTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10279599 ↗
• MalfunctionJul 15, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THERE WERE NO LIGHTS ON THE COMMUNICATOR. THE PATIENT REPORTED THAT THE COMMUNICATOR SMELLED SMOKE. THE COMMUNICATOR WAS NOT CONNECTING. THERE WERE NO PHYSICAL INJURIES AND PROPERTY DAMAGE REPORTED. THERE WERE NO POWER OUTAGE OR STORM REPORTED. THE COMMUNICATOR POWER SUPPLY USED WAS THE ORIGINAL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE DISCUSSED WITH THE PATIENT AND OPTED FOR PRODUCT REPLACEMENT. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10279512 ↗
• MalfunctionJan 15, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE COMMUNICATOR AND POWER CORD MELTED, STRIPPED, AND BLEW UP BECAUSE OF A LIGHTNING STORM. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE REPORTED THAT NO PHYSICAL INJURY NOR MEDICAL TREATMENT WAS NEEDED. THE PATIENT ALSO REPORTED SEVERAL DAMAGED ELECTRONICS AND HEARD A BIG BOOM IN THE HOUSE. THE COMPANY REPRESENTATIVE ADVISED TO REPLACE THE COMMUNICATOR. THE COMMUNICATOR WAS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9592704 ↗
• MalfunctionOct 20, 2019Power Problem; Power Problem

  IT WAS REPORTED THAT THE COMMUNICATOR EXPERIENCED SMOKE OR FIRE COMING OUT OF THE UNIVERSAL SERVICE BUS (USB) PORTS. THE PATIENT HAD THE MONITOR PACKED IN STORAGE BECAUSE SHE WAS MOVING AND THE CLINIC ASKED HER TO TAKE IT OUT AND SEND IN A READING, WHEN SHE PLUGGED IN THE MONITOR THERE WERE NO LIGHTS ON. THE PATIENT THEN SMELT SMOKE AND NOTICED IT WAS COMING OUT OF THE USB PORTS. THE PATIENT UNPLUGGED THE MONITOR AND THERE WERE NO DAMAGES OR INJURIES. THE PATIENT DOES NOT HAVE THE MONITOR ANYMORE. THE CLINIC GAVE HER A NEW ONE AND SHE DISCARDED THE OLD MONITOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9212459 ↗
• MalfunctionJul 20, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT CALLED AS THE COMMUNICATOR WAS VERY HOT AND HAD NO LIGHTS. THE PATIENT WAS PARTIALLY BLIND AND HAS DIFFICULTY UNPLUGGING THE COMMUNICATOR. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE COMPANY REPRESENTATIVE OPTED TO SEND A NEW COMMUNICATOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8809898 ↗
• MalfunctionJun 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR HAD NO POWER AS THE POWER CORD WAS BURNED UP. THE COMPANY REPRESENTATIVE SENT A RETURN LABEL TO THE PATIENT AND ORDERED A NEW COMMUNICATOR. THE COMMUNICATOR IS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6680647 ↗
• MalfunctionJan 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE POWER CORD WAS MELTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THE POWER CORD AND THE COMMUNICATOR WILL BE RETURNED FOR ANALYSIS. THE COMMUNICATOR WAS DEACTIVATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6283354 ↗
• MalfunctionJan 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR'S POWER CORD WAS BLOWN OUT OF THE SOCKET AND MELTED. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE VERIFIED THAT THERE WAS A LIGHTNING STRIKE THAT AFFECTED THE PATIENT'S HOUSE. THE COMPANY REPRESENTATIVE THEN SENT A RETURN LABEL AND A REPLACEMENT COMMUNICATOR TO THE PATIENT. THE COMMUNICATOR IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6283341 ↗
• MalfunctionOct 26, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMMUNICATOR HAD A BURNING SMELL. A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE ASKED ABOUT THE CONNECTION AND THE PHONE SERVICE THE PATIENT WAS USING FOR THE COMMUNICATOR. THE COMPANY REPRESENTATIVE DISCUSSED TO THE PATIENT OTHER PHONE CONNECTION OPTIONS FOR THE COMMUNICATOR ALONG WITH THE CELLULAR ADAPTER. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT TO REPLACE THE COMMUNICATOR AND A RETURN LABEL WAS SENT. THE COMMUNICATOR IS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6056600 ↗
• MalfunctionMay 6, 2016Inadequate User Interface; Inadequate User Interface

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS REMOTE HOME MONITOR AND DEVICE ARE IN RADIOFREQUENCY OVERUSE. TROUBLESHOOTING WAS PERFORMED WHICH DID SLIGHTLY IMPROVE THE OVERUSE TIME. AT THIS TIME, THE RADIOFREQUENCY OVERUSE HAS HAD AN IMPACT ON THE DEVICE'S BATTERY LONGEVITY AND WILL CONTINUE TO DO SO IF THE RADIOFREQUENCY OVERUSE CONTINUES. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5636516 ↗
• MalfunctionMay 6, 2016Inadequate User Interface; Inadequate User Interface

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND REMOTE HOME MONITORING SYSTEM ARE IN RADIOFREQUENCY OVERUSE. THERE IS RADIOFREQUENCY INTERFERENCE. A LONGEVITY CALCULATION WAS PERFORMED FROM THE DEVICE DATA AND DETERMINED THAT THE DEVICE HAS A SHORTENED LONGEVITY DUE TO THE INTERFERENCE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE REMOTE HOME MONITOR HAS BEEN TURNED OFF AND WILL ONLY BE TURNED ON WHEN USED MONTHLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND REMOTE HOME MONITORING SYSTEM REMAIN IN SERVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5636500 ↗

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