Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LifeVest Wearable Defibrillator Model 4000 Recalled by Zoll Manufacturing Corp. Due to Incorrect service code for properly catching critical defects...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zoll Manufacturing Corp. directly.
Affected Products
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Quantity: 33,670 units
Why Was This Recalled?
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zoll Manufacturing Corp.
Zoll Manufacturing Corp. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report