Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter… recallZ-0578-03 · Lifecor Inc · initiated Jan 10, 2003
Terminated All recalls posted in February 2003
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 Lifecor Inc 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
Wires may break or pull out, causing device to malfunction
FDA root cause category: Other
What the company is doing
The recalling firm telephone the end/prescribed users and distributors. Follow up letters were issued to those that received phone calls. The end/prescribed users'' physicians were also notified via letter.
Recall details
- Recall number
- Z-0578-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 10, 2003
- Posted by the FDA
- Feb 26, 2003
- Recalling firm
- Lifecor Inc
- Quantity
- 174 units
- FDA submissions
- P010030
- Distribution
- The device was shipped to distributors, hospitals, sales representatives. End users were prescribed by their physician. Distribution was to: CA, FL, GA, ID, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, UT and WA; and to Spain, Denmark, Italy, Turkey, Germany, United Kingdom, France and Belgium.
Product description
Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.
Code information (models, lots, serial numbers)
Product No 10A0889-A01
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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