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LATITUDE™ Programming System 3300

by Boston Scientific 10 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

Recall on shared PMA P910077; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00802526628900 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

10 recalls · 3 ongoing · FDA

    • Ongoing Z-0673-2024 FDA Class II initiated 30 Nov 2023 on shared PMA P910077

    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.

    • Ongoing Z-1216-2023 FDA Class II initiated 2 Feb 2023 on shared PMA P910077

    Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..

    • Ongoing Z-1669-2022 FDA Class II initiated 7 Jul 2022 on shared PMA P910077

    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.

    • Terminated Z-3260-2018 FDA Class II initiated 10 Sep 2018 on shared PMA P910077

    There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.

    • Terminated Z-1445-2012 FDA Not yet classified initiated 24 Feb 2012 on shared PMA P910077

    Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.

    • Terminated Z-1096-2012 FDA Unclassified (pre-2012) initiated 19 Dec 2011 on shared PMA P910077

    Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.

    • Terminated Z-0333-2012 FDA Unclassified (pre-2012) initiated 12 Oct 2011 on shared PMA P910077

    Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However, the mea

    • Terminated Z-0037-2012 FDA Unclassified (pre-2012) initiated 12 Aug 2011 on shared PMA P910077

    Boston Scientific has determined that under certain conditions, LATITUDE Paceart Integration (LPI) software may not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.

    • Terminated Z-1631-2010 FDA Unclassified (pre-2012) initiated 10 Sep 2009 on shared PMA P910077

    Boston Scientific has determined that alert conditions for a limited subset of out-of-range Daily Measurements related to leads may not be recognized by Model 6476 (United States) or Model 6468 (Europe) LATITUDE in-home communicators. If a communicator fails to recognize a valid alert situation, notification for this or subsequent alerts for the same test will not be displayed for physician review

    • Terminated Z-0002-2007 FDA Unclassified (pre-2012) initiated 19 May 2006 on shared PMA P910077

    Final software load did not occur prior to shipment of select programmers.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LATITUDE™ Programming System
Generic Name
Cardiac pulse generator programmer
Model / Ref / Catalog
3300
Primary DI / UDI-DI
00802526628900
PMA Number
FDA Product Code
OSR
GMDN Term
Cardiac pulse generator programmer
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (P910077)

Show all (12)

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No