PMA · Approved
Recalled · Class II · 2022Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator 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 Jul 18, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 332-day review. It has been recalled 14 times.
- Decided
- Jul 18, 1997
- Review
- 332 days
- Class
- Class III
- Product code
- LWS
- Recalls
- 14
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P960040 has 485 supplements since 1997: 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 |
|---|---|
| 1997 | 3 |
| 1998 | 5 |
| 1999 | 2 |
| 2000 | 6 |
| 2001 | 6 |
| 2002 | 2 |
| 2003 | 11 |
| 2004 | 12 |
| 2005 | 31 |
| 2006 | 37 |
| 2007 | 19 |
| 2008 | 28 |
| 2009 | 26 |
| 2010 | 24 |
| 2011 | 9 |
| 2012 | 37 |
| 2013 | 24 |
| 2014 | 29 |
| 2015 | 21 |
| 2016 | 23 |
| 2017 | 29 |
| 2018 | 18 |
| 2019 | 15 |
| 2020 | 14 |
| 2021 | 13 |
| 2022 | 15 |
| 2023 | 9 |
| 2024 | 5 |
| 2025 | 5 |
| 2026 | 7 |
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 7, 2022 | Class II | Z-1670-2022 | 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. |
| Oct 4, 2017 | Class II | Z-0077-2018 | Under Investigation by firm | The devices have an incorrect firmware configuration. |
| Oct 4, 2017 | Class II | Z-0079-2018 | Under Investigation by firm | The devices have an incorrect firmware configuration. |
| Oct 4, 2017 | Class II | Z-0078-2018 | Under Investigation by firm | The devices have an incorrect firmware configuration. |
| Mar 15, 2010 | Not classified | Z-1555-2010 | PMA | Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)… |
| Dec 1, 2009 | Not classified | Z-0610-2010 | Device Design | BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient… |
| Mar 4, 2009 | Not classified | Z-1621-2009 | Nonconforming Material/Component | In April 2007, Boston Scientific CRM communicated with physicians regarding the potential for reduced Elective Replacement Indicator (ERI) to Battery End of Life (EOL) time in a subset of implantable defibrillators due to degradation of a… |
| Jan 7, 2008 | Not classified | Z-1514-2008 | Device Design | Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously… |
| Jan 7, 2008 | Not classified | Z-1513-2008 | Device Design | Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously… |
| Mar 16, 2007 | Not classified | Z-0051-2008 | Device Design | Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain… |
| Mar 16, 2007 | Not classified | Z-0050-2008 | Device Design | Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain… |
| Jun 24, 2006 | Not classified | Z-1297-06 | Other | Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion in the affected devices. |
| May 15, 2006 | Not classified | Z-1292-06 | Other | Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely. |
| Apr 7, 2006 | Not classified | Z-0828-06 | Other | 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device… |
The 5 latest of 14 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/P960040 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960040: Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960040
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026