LATITUDE™ Programming System 3300 (UDI 00802526585005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00802526585005), received between Oct 18, 2018 and May 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Pacing Problem; Key or Button Unresponsive/not Working; Pacing Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER EXHIBITED PACING RATE WAS NOT AS EXPECTED AND DISPLAYED SCREEN FREEZE AND WAS REBOOTED AND RE-INTERROGATED AND SUCCESSFULLY OPERATED. THIS PROGRAMMER WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947185 ↗
• InjuryOct 18, 2018Defective Device; Material Integrity Problem; Key or Button Unresponsive/not Working; Defective Device; Material Integrity Problem; Key or Button Unresponsive/not Working

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING IN-OFFICE THRESHOLD TESTING, THE DISPLAY SCREEN BECAME UNRESPONSIVE AND DID NOT ALLOW THE PHYSICIAN TO END THE THRESHOLD TESTING WHEN REQUIRED. AS A RESULT, THE PATIENT WAS ABSENT OF PACING LONGER THAN EXPECTED AND BECAME DIZZY. THIS PROGRAMMER IS NO LONGER IN USE AT THIS FACILITY AND HAS SINCE BEEN COLLECTED FOR ANALYSIS; NO DATA HAD BEEN SAVED FOR REVIEW PRIOR TO THE RETURNED PRODUCT ANALYSIS. ANOTHER PROGRAMMER OF DIFFERENT MODEL TYPE WAS USED TO COMPLETE THE OFFICE EXAMINATION. THE FIELD LATER REPORTED THAT THIS WAS THE FIRST TIME THIS UNIT HAD BEEN UNRESPONSIVE AND NO TELEMETRY ISSUES WERE OBSERVED.

  Patient problems: Dizziness; No Patient Involvement

  MAUDE report 7979302 ↗

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