# P960040: Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator System

- Pathway: PMA
- Applicant: Boston Scientific
- Decided: Jul 18, 1997 after 332 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 14 (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-1670-2022: 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-0077-2018: The devices have an incorrect firmware configuration.
- Oct 4, 2017 · Class II · Z-0079-2018: The devices have an incorrect firmware configuration.
- Oct 4, 2017 · Class II · Z-0078-2018: The devices have an incorrect firmware configuration.
- Mar 15, 2010 · Not classified · Z-1555-2010: 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-0610-2010: 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 4, 2009 · Not classified · Z-1621-2009: 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 
- Jan 7, 2008 · Not classified · Z-1514-2008: 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 
- Jan 7, 2008 · Not classified · Z-1513-2008: 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 
- Mar 16, 2007 · Not classified · Z-0051-2008: 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
- Mar 16, 2007 · Not classified · Z-0050-2008: 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
- Jun 24, 2006 · Not classified · Z-1297-06: 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: 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-0828-06: 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

Source page: https://510kreport.com/device/P960040
Methodology: https://510kreport.com/methodology