Monitor portion of the LifeVest device - specifically the… recallZ-0883-2009 · Zoll Lifecor Corporation · initiated Oct 21, 2008
Terminated All recalls posted in January 2009
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
The charging circuit will not shut down properly.
FDA root cause category: Component design/selection
What the company is doing
Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.
Recall details
- Recall number
- Z-0883-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 21, 2008
- Posted by the FDA
- Jan 28, 2009
- Recalling firm
- Zoll Lifecor Corporation
- Quantity
- 1685 units
- Product code
- MVK
- FDA submissions
- P010030
- Distribution
- Nationwide. OUS: Germany, United Kingdom, Italy, and France.
Product description
Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Code information (models, lots, serial numbers)
model numbers WCD3000 and WCD3100
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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