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

FDA device recall Z-0061-2008 · posted 2007-10-18 · Terminated

Recall details

Recalling firm

Zoll Lifecor Corporation

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MVK

Quantity affected

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.

Date initiated

2007-09-14

Date posted

2007-10-18

Date terminated

2008-06-13

Location

Pittsburgh, PA