Events

Recall of LifeVest Wearable Defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Manufacturing Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78926
  • Event Risk Class
    Class 2
  • Event Number
    Z-0353-2018
  • Event Initiated Date
    2017-09-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160876
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wearable automated external defibrillator - Product Code MVK
  • Reason
    Incorrect service code for properly catching critical defects during self-check. potential for defibrillation shock failure.
  • Action
    On September 14, 2017, ZOLL Manufacturing Corporation issued a patient safety alert notice dated September 12, 2017 to all active patients via courier service. As of November 2, 2017, a copy of this same patient Safety Alert notice is included with all current device shipments. The purpose of the communication is to revise the training patients received about the "Call for service" message. In certain cases, a "Call for service - Message Code 102" could mean that your LifeVest may not be able to deliver therapy if you need it. Users should call ZOLL immediately for a replacement LifeVest if a "Call for service - Message Code 102" appears on the screen. A replacement will be provided within 24 hours. Patients are instructed to continue using the LifeVest as prescribed by their physician.

Device

LifeVest Wearable Defibrillator
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Nationwide
  • Product Description
    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.
  • Manufacturer
    Zoll Manufacturing Corp.

Manufacturer

Zoll Manufacturing Corp.
  • Manufacturer Address
    Zoll Manufacturing Corp., 121 Gamma Dr, Pittsburgh PA 15238-2919
  • Manufacturer Parent Company (2017)
    Zoll Manufacturing Corporation
  • Source
    USFDA