# P010012: Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrilll

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: May 2, 2002 after 429 days
- Product code: NIK (Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D))
- Device class: 3
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 7, 2022 · Class II · Z-1671-2022: 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 tr
- Oct 4, 2017 · Class II · Z-0079-2018: The devices have an incorrect firmware configuration.
- Oct 4, 2017 · Class II · Z-0081-2018: The devices have an incorrect firmware configuration.
- Oct 4, 2017 · Class II · Z-0080-2018: The devices have an incorrect firmware configuration.
- Mar 15, 2010 · Not classified · Z-1556-2010: Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronizatio
- Dec 1, 2009 · Not classified · Z-0609-2010: 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 d
- Mar 23, 2007 · Not classified · Z-1049-2007: 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 d
- Mar 23, 2007 · Not classified · Z-1052-2007: 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 d
- Mar 23, 2007 · Not classified · Z-1053-2007: 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 d
- Mar 23, 2007 · Not classified · Z-1054-2007: 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 d
- Mar 23, 2007 · Not classified · Z-1047-2007: 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 d
- Mar 23, 2007 · Not classified · Z-1055-2007: 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 d
- Mar 16, 2007 · Not classified · Z-0047-2008: 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: C
- May 15, 2006 · Not classified · Z-1288-06: 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
- Apr 7, 2006 · Not classified · Z-0825-06: 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 defibrillatio
- Apr 7, 2006 · Not classified · Z-0826-06: 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 defibrillatio
- Apr 7, 2006 · Not classified · Z-0827-06: 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 defibrillatio
- Mar 11, 2006 · Not classified · Z-0863-06: 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: 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

Source page: https://510kreport.com/device/P010012
Methodology: https://510kreport.com/methodology