Zoll Lifecor Corporation 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Zoll Lifecor Corporation
Lot Codes / Batch Numbers
Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
Products Sold
Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
Zoll Lifecor Corporation is recalling Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator w due to Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction caus. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026