Class II — Zoll Manufacturing Corp.
| Recalling firm | ZOLL Manufacturing Corporation |
|---|---|
| Registered facility | ZOLL Manufacturing Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure |
| 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. |
| Quantity | 33,670 units |
| Distribution | US Nationwide |
| Initiated | 2017-09-12 |
| Classified | 2018-01-14 |
| Terminated | 2021-08-10 |
| Recall number | Z-0353-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zoll Manufacturing Corp. (Z-0353-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78926/
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