FDA Device recall Z-0353-2018
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01
- FDA Device
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01 by Zoll Manufacturing, citing incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0353-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-12 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zoll Manufacturing |
| Distribution | US |
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
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Identifiers
| code_info | All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0353-2018%22
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