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).
This recall has been terminated (originally issued October 18, 2007).
- Company
- Zoll Lifecor Corporation
- Recall Initiated
- September 14, 2007
- Posted
- October 18, 2007
- Terminated
- June 13, 2008
- Recall Number
- Z-0061-2008
- Quantity
- 2006 packs
- Firm Location
- Pittsburgh, PA
- Official Source
- View on FDA website ↗
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.
Distribution
The product was shipped nationwide to patients. The product was also shipped to distributors in Germany, United Kingdom, Italy, Spain, France, and Denmark.
Lot / Code Info
Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
Root Cause
Device Design
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.