PMA · Approved
Recalled · Class I · 2025Endotak Lead System
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 Aug 26, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 616-day review. It has a Class I recall. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Aug 26, 1993
- Review
- 616 days
- Class
- Class III
- Product code
- LWS
- Recalls
- 3 (3 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P910073 has 179 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 | 3 |
| 1995 | 10 |
| 1996 | 5 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 9 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 7 |
| 2005 | 12 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 5 |
| 2009 | 2 |
| 2010 | 8 |
| 2011 | 9 |
| 2012 | 16 |
| 2013 | 6 |
| 2014 | 6 |
| 2015 | 3 |
| 2016 | 8 |
| 2017 | 5 |
| 2018 | 7 |
| 2019 | 5 |
| 2020 | 2 |
| 2021 | 9 |
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 5 |
| 2025 | 4 |
| 2026 | 9 |
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.
1 device in this family has a Class I recall. 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2025 | Class I | Z-2325-2025 | Component design/selection | Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac… |
| Jul 24, 2025 | Class I | Z-2326-2025 | Component design/selection | Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac… |
| Jul 24, 2025 | Class I | Z-2327-2025 | Component design/selection | Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac… |
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/P910073 · printed Nov 6, 2026
Cite this page
510(k) Report. “P910073: Endotak Lead System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P910073
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026