PMA · Approved
Recalled · Class II · 2023Ventak (R) PRX (TM) Model 1700,1705 Pulse Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · LWS Implantable Cardioverter Defibrillator (Non-Crt)
Approved on Jun 17, 1994 through premarket approval, which rests on the device’s own clinical evidence after a 907-day review. It has been recalled 10 times.
- Decided
- Jun 17, 1994
- Review
- 907 days
- Class
- Class III
- Product code
- LWS
- Recalls
- 10
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P910077 has 184 supplements since 1994: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 8 |
| 1997 | 3 |
| 1998 | 4 |
| 1999 | 3 |
| 2000 | 5 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 4 |
| 2004 | 5 |
| 2005 | 7 |
| 2006 | 8 |
| 2007 | 15 |
| 2008 | 8 |
| 2009 | 7 |
| 2010 | 10 |
| 2011 | 7 |
| 2012 | 11 |
| 2013 | 9 |
| 2014 | 10 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 8 |
| 2018 | 4 |
| 2019 | 9 |
| 2020 | 6 |
| 2021 | 5 |
| 2022 | 4 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2023 | Class II | Z-0673-2024 | Under Investigation by firm | 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 | Software Manufacturing/Software Deployment | 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… |
| Jul 7, 2022 | Class II | Z-1669-2022 | Under Investigation by firm | 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. |
| Sep 10, 2018 | Class II | Z-3260-2018 | Device Design | There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation. |
| Feb 24, 2012 | Not classified | Z-1445-2012 | Process control | Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients. |
| Dec 19, 2011 | Not classified | Z-1096-2012 | Software design | 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. |
| Oct 12, 2011 | Not classified | Z-0333-2012 | Software design | 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… |
| Aug 12, 2011 | Not classified | Z-0037-2012 | Software design | 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… |
| Sep 10, 2009 | Not classified | Z-1631-2010 | Software design | 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… |
| May 19, 2006 | Not classified | Z-0002-2007 | Other | Final software load did not occur prior to shipment of select programmers. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWS devicesLWS Implantable Cardioverter Defibrillator (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWS
97in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWS
Too few LWS 510(k)s in any year since 2007 to give a median.
Recalls per year · LWS
2in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · LWS
24,303in 2025
MAUDE reports naming product code LWS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 70 | — | 4 | 10,330 |
| 2008 | 94 | — | 3 | 11,327 |
| 2009 | 80 | — | 8 | 13,768 |
| 2010 | 119 | — | 6 | 17,321 |
| 2011 | 136 | — | 8 | 15,097 |
| 2012 | 129 | — | 5 | 12,820 |
| 2013 | 148 | — | 1 | 17,242 |
| 2014 | 168 | — | 0 | 18,594 |
| 2015 | 100 | — | 2 (1) | 14,040 |
| 2016 | 145 | — | 2 (2) | 16,638 |
| 2017 | 162 | — | 7 (5) | 18,454 |
| 2018 | 142 | — | 1 | 17,228 |
| 2019 | 98 | — | 0 | 16,184 |
| 2020 | 125 | — | 6 (3) | 16,909 |
| 2021 | 111 | — | 0 | 19,654 |
| 2022 | 91 | — | 3 | 23,454 |
| 2023 | 101 | — | 2 | 28,701 |
| 2024 | 108 | — | 0 | 25,202 |
| 2025 | 97 | — | 2 (1) | 24,303 |
| 2026 | 93 | — | 0 | — |
https://510kreport.com/device/P910077 · printed Nov 6, 2026
Cite this page
510(k) Report. “P910077: Ventak (R) PRX (TM) Model 1700,1705 Pulse Generator.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P910077
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026