Battery Pack portion of the LifeVest device. The LifeVest… recallZ-0061-2008 · Zoll Lifecor Corporation · initiated Sep 14, 2007
Terminated All recalls posted in October 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zoll Lifecor Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0061-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 14, 2007
- Posted by the FDA
- Oct 18, 2007
- Recalling firm
- Zoll Lifecor Corporation
- Quantity
- 2006 packs
- Product code
- MVK
- FDA submissions
- P010030
- 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 description
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).
Code information (models, lots, serial numbers)
Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
Other devices under the same FDA submission
12 devices cleared under P010030 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LifeVest Wearable Defibrillator LifeVest 4000 MonitorZoll Manufacturing Corporation · Wearable Automated External Defibrillator2,039 deaths36,128 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Electrode BeltZoll Manufacturing Corporation · Wearable Automated External Defibrillator44 deaths15,404 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery PackZoll Manufacturing Corporation · Wearable Automated External Defibrillator1 death9,929 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery ChargerZoll Manufacturing Corporation · Wearable Automated External Defibrillator1 death6,327 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Electrode BeltZoll Manufacturing Corporation · Wearable Automated External Defibrillator14 deaths4,460 reports
- LifeVest Wearable Defibrillator LifeVest 4000 Battery ChargerZoll Manufacturing Corporation · Wearable Automated External Defibrillator1 death1,296 reports
- LifeVest Wearable Defibrillator LifeVest 5100 Battery PackZoll Manufacturing Corporation · Wearable Automated External Defibrillator557 reports
- LifeVest Wearable Defibrillator LifeVest 5100 MonitorZoll Manufacturing Corporation · Wearable Automated External Defibrillator9 deaths482 reports
- LifeVest Wearable Defibrillator LifeVest 5100 Electrode BeltZoll Manufacturing Corporation · Wearable Automated External Defibrillator1 death114 reports
- LifeVest Wearable Defibrillator LifeVest 5100 Battery ChargerZoll Manufacturing Corporation · Wearable Automated External Defibrillator44 reports
- Hospital Wearable Defibrillator HWD 1000 MonitorZoll Manufacturing Corporation · Wearable Automated External Defibrillator5 reports
- Hospital Wearable Defibrillator HWD 1000 Battery ChargerZoll Manufacturing Corporation · Wearable Automated External Defibrillator3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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