# P010030: Wearable Cardioverter Defibrillator (WCD) 2000 Lifevest

- Pathway: PMA
- Applicant: Zoll Manufacturing Corporation
- Decided: Dec 18, 2001 after 228 days
- Product code: MVK (Wearable Automated External Defibrillator)
- Device class: 3
- Recalls of this device: 6 (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
- Sep 12, 2017 · Class II · Z-0353-2018: Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
- Sep 24, 2010 · Not classified · Z-0625-2011: The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying 
- Oct 21, 2008 · Not classified · Z-0883-2009: The charging circuit will not shut down properly.
- Sep 14, 2007 · Not classified · Z-0061-2008: Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and p
- Apr 27, 2007 · Not classified · Z-0936-2007: The electrodes do not properly release conductive gel
- Jan 10, 2003 · Not classified · Z-0578-03: Wires may break or pull out, causing device to malfunction

Source page: https://510kreport.com/device/P010030
Methodology: https://510kreport.com/methodology