Skip to content

Na 6504

by Boston Scientific United States GUDID

Product code LWS

Regulatory status

as of 25 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00802526489235 UDI-DIDate24 Sep 2014ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

10 recalls · 3 ongoing · FDA

    • Ongoing Z-0673-2024 FDA Class II initiated 30 Nov 2023

    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

    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

    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

    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

    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

    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

    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

    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

    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

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

Specification

GUDID · synced 22 Oct 2026

Trade Name
Na
Generic Name
Pacing/defibrillation lead cap kit
Model / Reference
6504
Primary DI / UDI-DI
00802526489235
PMA Number
FDA Product Code
LWS
GMDN Term
Pacing/defibrillation lead cap kit
Device Class
Class III
Commercial Distribution
In Commercial Distribution

Related devices

Category: Pacing/defibrillation lead cap kit

Cleared under the same submission (P910077)

Show all (12)

Similar devices

Also classified as Pacing/defibrillation lead cap kit.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI ace1d544-69f6-47f2-b8d7-0413023c6a82 35 fields · synced 22 Oct 2026