Zoll LifeVest Wearable Defibrillator Model 4000 Recall: Risk of Shock Failure
Zoll recalls LifeVest Model 4000 wearable defibrillators due to potential shock failure during self-checks. Affected units have specific serial numbers. Contact Zoll for details.
Use caution until it’s fixed
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Contact the company
What happened, in plain English
Zoll is recalling its LifeVest Wearable Defibrillator Model 4000 because it may fail to catch critical defects during self-checks, risking defibrillation shock failure. This could be dangerous for patients who rely on the device for sudden cardiac arrest prevention. Read more at govinfonow.com/recall/73031-zoll-lifevest-wearable-defibrillator-model-4000-recall-risk-of-shock.
Source Summary by GovInfoNow · govinfonow.com/recall/73031-zoll-lifevest-wearable-defibrillator-model-4000-recall-risk-of-shock · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0353-2018
Cite this page
“Zoll LifeVest Wearable Defibrillator Model 4000 Recall: Risk of Shock Failure.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/73031-zoll-lifevest-wearable-defibrillator-model-4000-recall-risk-of-shock. Based on FDA recall #Z-0353-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0353-2018%22&limit=1).
Why it’s dangerous
The device may not correctly identify critical defects during self-checks, which could lead to defibrillation shock failure. This means the device might not work when needed during a cardiac emergency.
Who’s affected
Patients 18 years and older who use the LifeVest system for sudden cardiac arrest prevention are most at risk. The recall affects all units with the specified product number.
How to tell if you have this one
Check the product number on the device: 10A0988-A01. All units with this model number are affected, regardless of serial number.
- Brand
Zoll- Category
Medical device
What to do — step by step
Check Device Status
Verify the product number on the device to confirm it matches 10A0988-A01.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device safe to use?
The recall indicates a potential risk of shock failure during self-checks, so it is not safe to use without the remedy.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0353-2018 (September 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0353-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.