ZOOM® LATITUDE® 3120 (UDI 00802526575303)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00802526575303), received between May 6, 2019 and Jun 3, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 reports).

4 FDA recall records name this device's identifier, 4 still open.

8 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.

Recalls naming this device

1. Nov 30, 2023Class IIOpen, Classified

   The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.

   Z-0673-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1670-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1671-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1669-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHILE PERFORMING A THREHSOLD TEST THE SCREEN OF THIS PROGRAMMER FROZE PREVENTING THE HALTING OF THIS TEST. THE PATIENT WAS DEPENDENT AND DUE TO LOSS OF CAPTURE (LOC), THE PATIENT LOST CONSCIOUSNESS. THE PROGRAMMER WAS REMOVED FROM SERVICE. TECHNICAL SERVICES (TS) EDUCATED THE CALLER THAT HAD THE PROGRAMMER WAND BEEN REMOVED FROM THE PATIENT THIS TOO WOULD HAVE ENDED THE THRESHOLD TEST.

  Patient problems: Syncope/Fainting

  MAUDE report 14595160 ↗
• MalfunctionFeb 4, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PROGRAMMER HEATED UP AND MELTED. THE PROGRAMMER WAS RETURNED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9667947 ↗
• MalfunctionJan 31, 2020Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PROGRAMMER HAD A POPPING SOUND WHEN IT TURNED ON AND IT HAD SMOKE. THIS PROGRAMMER WILL BE RETURNED FOR ANALYSIS. NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9653794 ↗
• MalfunctionMay 6, 2019Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PROGRAMMER STARTED SMOKING AND SMELLED BURNT UPON INTERROGATING A PATIENT. THE FIELD REPRESENTATIVE WILL RETURN THE PROGRAMMER BACK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8581825 ↗

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-1216-2023 · Feb 2, 2023 · Open, Classified
  LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
• 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