CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report
LifeVest Wearable Defibrillator recalled by Zoll Manufacturing
Zoll Manufacturing is recalling LifeVest Wearable Defibrillator, distributed nationwide in the US. The recall was initiated on 12 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0353-2018
- FDA event ID
- 78926
- Recalling firm
- Zoll Manufacturing, Pittsburgh, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2017
- FDA classified
- 14 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 12 Sep 2017 | Recall initiated by company | |
| 14 Jan 2018 | Classified by FDA | +124 days |
| 24 Jan 2018 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Which lots are affected?
All Serial Numbers
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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