FDA recall Z-0353-2018

Product

LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

Reason for recall

Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2017-09-12

Report date

2018-01-24

Termination date

2021-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2018