LifeVest Wearable Defibrillator Model 4000 — Class II medical device recall Z-0353-2018
Terminated recall by Zoll Manufacturing Corp., reported 2018-01-24, distributed nationwide. Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation
| Recall number | Z-0353-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zoll Manufacturing Corp., Pittsburgh, PA, United States |
| Recall initiated | 2017-09-12 |
| Classified | 2018-01-14 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2021-08-10 |
| Distributed | Nationwide (US) |
| Quantity | 33,670 units |
| Model numbers | 4000 |
Product
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.
Reason for recall
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0353-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.