Zoll LifeVest Wearable Defibrillator Recalled for Defibrillation Shock Failure Risk
Zoll Manufacturing Corp. is recalling 33,670 LifeVest Wearable Defibrillators due to an incorrect service code that may prevent the device from detecting critical defects, potentially leading to defibrillation shock failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with a potential for defibrillation shock failure, which poses a significant risk of serious injury or death to patients at risk for sudden cardiac arrest.
Plain-English summary
Zoll Manufacturing Corp. is recalling 33,670 units of the LifeVest Wearable Defibrillator Model 4000 (Product Number 10A0988-A01) distributed nationwide in the United States. The recall involves all serial numbers of the device.
The recall is being conducted because of an incorrect service code used during the device's self-check process. This error may prevent the system from properly catching critical defects, creating a potential for defibrillation shock failure. 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.
Consumers with this device should contact Zoll Manufacturing Corp. for further instructions on how to resolve the issue.
The recalled product
- 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.
- Manufacturer
- Zoll Manufacturing Corp.
- Affected units
- 33,670
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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