Z-0061-2008

Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a...

Name: Z-0061-2008 Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a...
Creator: Zoll Lifecor Corporation
Published: 2007-09-14
License: https://open.fda.gov/license/

ZOLL Manufacturing Corporation / initiated 2007-09-14 / Terminated / root cause: design

FDA source

Zoll Lifecor Corporation began a recall of 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) on 2007-09-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0061-2008
Status: Terminated
Initiated: 2007-09-14
Posted: 2007-10-18
Terminated: 2008-06-13
Recalling firm: ZOLL Manufacturing Corporation
Product: 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).
Product code: MVK Wearable Automated External Defibrillator
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 2006 packs
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 codes and lots: Product number 10A0894-A01. Serial numbers 71000101 through 71003176.

Product code MVK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)