LATITUDE™ Programming System 3300 (UDI 00802526627903)Recalls & reported problems
Boston Scientific Corporation · Programming System · Class 3
All models of LATITUDE Programming System (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00802526627903), received between Aug 20, 2026 and Aug 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Application Program Problem1
- Key or Button Unresponsive/not Working1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Application Program Problem; Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358886 ↗
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, ClassifiedBoston 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, ClassifiedLATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
- Z-1669-2022 · Jul 7, 2022 · Open, ClassifiedThe 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 · TerminatedModel 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 · TerminatedBoston 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 · TerminatedLATITUDE 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 · TerminatedLATITUDE 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 · TerminatedLATITUDE 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 · TerminatedBoston 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 · TerminatedGuidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable p
Other Pacemaker/icd/crt non-implanted components devices
- Gallant™ CDDRA500QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components2 recalls33 deaths3,028 reports
- NA 229047Medtronic, Inc. · Pacemaker/icd/crt non-implanted components1 recall662 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls559 reports
- CareLink Encore™ 29901AMedtronic, Inc. · Pacemaker/icd/crt non-implanted components2 recalls474 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls422 reports
- Medtronic CareLink® Programmer 2090Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls151 reports
- Medtronic CareLink® Programmer 2090AA4Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls82 reports
- Entrant™ CDDRA300QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components1 recall2 deaths158 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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