PMA · Approved
Recalled · Class II · 2022Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrilll
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Approved on May 2, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 429-day review. It has been recalled 19 times.
- Decided
- May 2, 2002
- Review
- 429 days
- Class
- Class III
- Product code
- NIK
- Recalls
- 19
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P010012 has 580 supplements since 2002: 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 |
|---|---|
| 2002 | 5 |
| 2003 | 13 |
| 2004 | 15 |
| 2005 | 34 |
| 2006 | 51 |
| 2007 | 21 |
| 2008 | 33 |
| 2009 | 31 |
| 2010 | 27 |
| 2011 | 15 |
| 2012 | 43 |
| 2013 | 27 |
| 2014 | 33 |
| 2015 | 25 |
| 2016 | 32 |
| 2017 | 35 |
| 2018 | 20 |
| 2019 | 22 |
| 2020 | 15 |
| 2021 | 20 |
| 2022 | 17 |
| 2023 | 12 |
| 2024 | 10 |
| 2025 | 9 |
| 2026 | 15 |
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 NIK? 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-1671-2022 | 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-0079-2018 | Under Investigation by firm | The devices have an incorrect firmware configuration. |
| Oct 4, 2017 | Class II | Z-0081-2018 | Under Investigation by firm | The devices have an incorrect firmware configuration. |
| Oct 4, 2017 | Class II | Z-0080-2018 | Under Investigation by firm | The devices have an incorrect firmware configuration. |
| Mar 15, 2010 | Not classified | Z-1556-2010 | 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-0609-2010 | 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 23, 2007 | Not classified | Z-1049-2007 | Other | Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time… |
| Mar 23, 2007 | Not classified | Z-1052-2007 | Other | Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time… |
| Mar 23, 2007 | Not classified | Z-1053-2007 | Other | Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time… |
| Mar 23, 2007 | Not classified | Z-1054-2007 | Other | Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time… |
| Mar 23, 2007 | Not classified | Z-1047-2007 | Other | Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time… |
| Mar 23, 2007 | Not classified | Z-1055-2007 | Other | Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time… |
| Mar 16, 2007 | Not classified | Z-0047-2008 | 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… |
| May 15, 2006 | Not classified | Z-1288-06 | 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-0825-06 | 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… |
| Apr 7, 2006 | Not classified | Z-0826-06 | 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… |
| Apr 7, 2006 | Not classified | Z-0827-06 | 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… |
| Mar 11, 2006 | Not classified | Z-0863-06 | Other | Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted. |
| Sep 30, 2005 | Not classified | Z-0891-06 | Other | Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NIK devicesNIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIK
56in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NIK
Too few NIK 510(k)s in any year since 2007 to give a median.
Recalls per year · NIK
1in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NIK
10,855in 2025
MAUDE reports naming product code NIK, 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 | 53 | — | 9 | 924 |
| 2008 | 62 | — | 1 | 3,021 |
| 2009 | 43 | — | 2 | 4,177 |
| 2010 | 51 | — | 7 | 5,668 |
| 2011 | 50 | — | 0 | 5,944 |
| 2012 | 83 | — | 2 | 5,582 |
| 2013 | 50 | — | 0 | 7,373 |
| 2014 | 76 | — | 0 | 10,731 |
| 2015 | 49 | — | 0 | 7,828 |
| 2016 | 109 | — | 2 (1) | 13,255 |
| 2017 | 112 | — | 9 (5) | 16,265 |
| 2018 | 91 | — | 0 | 8,348 |
| 2019 | 62 | — | 0 | 7,266 |
| 2020 | 75 | — | 3 | 9,609 |
| 2021 | 67 | — | 0 | 10,134 |
| 2022 | 62 | — | 1 | 10,646 |
| 2023 | 58 | — | 0 | 11,897 |
| 2024 | 56 | — | 0 | 11,697 |
| 2025 | 56 | — | 0 | 10,855 |
| 2026 | 44 | — | 0 | — |
https://510kreport.com/device/P010012 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010012: Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrilll.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026