PMA · Approved
Recalled · Class II · 2023Subcutaneous Implantable Defibrillator (S-Icd) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LWS Implantable Cardioverter Defibrillator (Non-Crt)
Approved on Sep 28, 2012 through premarket approval, which rests on the device’s own clinical evidence after a 280-day review. It has been recalled 11 times.
- Decided
- Sep 28, 2012
- Review
- 280 days
- Class
- Class III
- Product code
- LWS
- Recalls
- 11
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P110042 has 208 supplements since 2012: 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 |
|---|---|
| 2012 | 1 |
| 2013 | 20 |
| 2014 | 18 |
| 2015 | 10 |
| 2016 | 12 |
| 2017 | 30 |
| 2018 | 20 |
| 2019 | 13 |
| 2020 | 19 |
| 2021 | 17 |
| 2022 | 10 |
| 2023 | 15 |
| 2024 | 9 |
| 2025 | 2 |
| 2026 | 12 |
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 |
|---|---|---|---|---|
| Jul 11, 2023 | Class II | Z-2441-2023 | Software design | There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval. |
| Jul 11, 2023 | Class II | Z-2442-2023 | Software design | There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval. |
| Sep 30, 2022 | Class II | Z-0152-2023 | Under Investigation by firm | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. |
| Sep 30, 2022 | Class II | Z-0151-2023 | Under Investigation by firm | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. |
| Nov 1, 2018 | Class II | Z-0474-2019 | Device Design | Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions. |
| Jun 29, 2017 | Class II | Z-3037-2017 | Software design | The device can deliver an atypical amount of energy due to memory corruption inside the device. |
| Jun 29, 2017 | Class II | Z-3039-2017 | Software design | The device can deliver an atypical amount of energy due to memory corruption inside the device. |
| Jun 29, 2017 | Class II | Z-3038-2017 | Software design | The device can deliver an atypical amount of energy due to memory corruption inside the device. |
| Jan 12, 2017 | Class II | Z-1178-2017 | Software design | There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active… |
| Sep 17, 2015 | Class II | Z-0232-2016 | Process design | Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during… |
| Mar 1, 2013 | Class II | Z-0965-2013 | Software design | An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the… |
The 5 latest of 11 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. 2012, this device’s year, is highlighted.
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/P110042 · printed Nov 6, 2026
Cite this page
510(k) Report. “P110042: Subcutaneous Implantable Defibrillator (S-Icd) System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P110042
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026