# P910077: Ventak (R) PRX (TM) Model 1700,1705 Pulse Generator

- Pathway: PMA
- Applicant: Boston Scientific
- Decided: Jun 17, 1994 after 907 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 30, 2023 · Class II · Z-0673-2024: 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.
- Feb 2, 2023 · Class II · Z-1216-2023: 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 Hea
- Jul 7, 2022 · Class II · Z-1669-2022: 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 tr
- Sep 10, 2018 · Class II · Z-3260-2018: There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
- Feb 24, 2012 · Not classified · Z-1445-2012: Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.
- Dec 19, 2011 · Not classified · Z-1096-2012: 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 
- Oct 12, 2011 · Not classified · Z-0333-2012: 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 
- Aug 12, 2011 · Not classified · Z-0037-2012: 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 va
- Sep 10, 2009 · Not classified · Z-1631-2010: 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 (Europ
- May 19, 2006 · Not classified · Z-0002-2007: Final software load did not occur prior to shipment of select programmers.

Source page: https://510kreport.com/device/P910077
Methodology: https://510kreport.com/methodology