The FDA has issued a safety alert for the Zoll LifeVest 4000, an external, wearable cardioverter defibrillator, saying it may fail to deliver appropriate therapy for potentially fatal arrhythmias.
According to Medscape, the LifeVest 400 may deliver appropriate shocks as a result of “a fault that prevents the device from charging its high-energy capacitors.”
The defect can occur when the device displays a warning to “Call ZOLL for service, Message Code 102.” The FDA says that the warning “does not explicitly indicate to the patient that the device cannot be used and that the patient should call Zoll immediately.”
The company reports that 33,670 device have been distributed as of November 2017. The above message has displayed on roughly 0.1% of the devices.
Zoll says it is aware of one death associated with the device’s failure to deliver treatment after the message appeared.
Recalls occur when a medical device is defective or a risk to a patient’s health (or both). A device is considered to be recalled if the manufacturer takes actions to correct or remove the device that violates FDA law. In some cases, the recalled device may not necessarily need to be removed from a patient, or the risks of removal outweigh the risk of leaving it in place.
Types of actions that result in a medical device recall include:
The FDA is in charge of monitoring all medical devices and drugs available for consumer use. In most cases, a company, including manufacturers and/or distributors, will usually recall their medical devices on their own or voluntarily. However, if a medical device is associated with significant health problems or death, the FDA can legally require a company to recall a device immediately.
When a company recalls a medical device, they will: