Events

Recall of Battery Pack portion of the LifeVest device

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

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
    44942
  • Event Risk Class
    Class 3
  • Event Number
    Z-0061-2008
  • Event Initiated Date
    2007-09-14
  • Event Date Posted
    2007-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64559
  • 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
    battery - Product Code MVK
  • Reason
    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 prevents the pack from recharging.
  • Action
    Patients currently using the LifeVest should continue to do so while the product removal is underway. Advisory notices will be sent via first class mail 9/14/2007 to all active patients using the LifeVest device. Product replacements began on 8/31/07 by shipping out revised battery packs for new patient use. Shipments of new battery packs will continue based on production capacity and material availability. Any patients expected to be using the device longer than 5 months will be provided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the same shipping box.

Device

Battery Pack portion of the LifeVest device
  • Model / Serial
    Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The product was shipped nationwide to patients. The product was also shipped to distributors in Germany, United Kingdom, Italy, Spain, France, and Denmark.
  • Product Description
    Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
  • Manufacturer
    Zoll Lifecor Corporation

Manufacturer

Zoll Lifecor Corporation
  • Manufacturer Address
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source
    USFDA