FDA Medical Device Recalls (openFDA)
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 number
- Z-0061-2008
- Recalling firm
- Zoll Lifecor 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).
- Status
- Terminated
- Initiated
- 2007-09-14
- Posted
- 2007-10-18
- Terminated
- 2008-06-13
- 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.
- 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
- 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.
- Lot, serial or model codes
- Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010030"]
- Product code
- MVK
- Firm FEI
- 3008642652
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28