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FDA Announces Zoll LifeVest Recall After One Reported Death

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On January 14, 2018, the FDA alerted the public and healthcare professionals to a Class 2 recall of the Zoll LifeVest Sure-T Wearable Cardioverter Defibrillator (Model 4000).  A Class 2 recall indicates a situation in which the use of the product may cause adverse health consequences.  About 33,000 of the units were covered by the recall.

In an accompanying safety communication, the FDA stated it was aware of at least one patient death related to the LifeVest’s failure to operate as expected.  Zoll has recommended that customers with affected units call the company immediately for a free replacement.

Zoll LifeVest May Not Operate as Expected

Zoll sent out a letter to patients in September 2017 telling them to watch for the “Call for Service—Message Code 102” notice on the devices. According to the company, Zoll LifeVests that display this message may not be able to deliver therapy when needed.  The FDA reported that when this message displays, the device may not be able to charge its high-energy capacitors, and will not be able to save a patient’s life as it is designed to do.

A Zoll LifeVest is similar to an implantable cardioverter defibrillator (ICD), which is implanted in a patient’s chest to help control irregular or racing heartbeat. Some patients, however, are not good candidates for an ICD, choose not to be implanted with them, or have to wait for a while before they can go forward with the procedure.

Those who are at risk for sudden cardiac arrest can use a LifeVest Wearable Cardioverter Defibrillator. This device consists of two parts:

  1. a belt-like garment that the patient wears around his or her chest, and
  2. the electric monitor device that attaches via a holster to the waist.

The garment contains two electrodes that monitor the heart’s rhythm, looking for any potentially dangerous changes. If it detects an abnormally fast or irregular heartbeat, the device is supposed to send out a series of alarms, and then give the patient a shock to restore the heartbeat to a normal rhythm.

The devices are designed to give patients peace of mind and allow them to live their lives without fear that a sudden heart rate change could result in heart attack and death. Devices that display this “call for service” message, however, may be useless for this purpose.

Indeed, the failure of the device to charge its high-energy capacitors could actually prevent a patient from receiving a life-saving shock when needed.

Some Patients Report Discomfort with Zoll LifeVest

The FDA’s database of adverse events lists a number of incidences involving the Zoll LifeVest, including one in which a patient received 40 inappropriate shocks from the device while in the hospital. Other reports indicate that patients have found the device too uncomfortable to wear—one man passed away after taking it off.

The American Heart Association Support Forum provides a forum where patients can share their experiences with the Zoll LifeVest.  In many of those messages, patients are describing that they’ve encountered various issues and problems with the vests.  Some patients describe them as uncomfortable, bulky, and heavy, and others report instances where the vest tried to initiate unnecessary treatment.

1 Comment

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  1. T Lea Quick says:
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    I feel ZOLL put money before my husbands’ life when they inactivated the LifeVest after our insurance company denied the $3670.00 claim.
    After ZOLL inactivated the service, they sent us a “member’s grievance form.” showing 61 days as “dates of service” when the LifeVest was in use for a total of 12 days, before ZOLL shut the device off without notice,.
    Zoll received a payment of $3670.00 for 12 days of service, and now they’re (ZOLL) is refusing to send me a copy of the documents submitted to our insurance company. I guess they didn’t need our signature to file an appeal.
    ZOLL is a company with many complaints filed against them, if possible, steer clear of this company, they are crooks.