Life-Saving Devices That May Fail When You Need Them Most: The Ongoing Concerns Surrounding the ZOLL LifeVest 4000

Morgan & Morgan is currently representing the family of a patient who tragically lost their life while wearing a ZOLL LifeVest 4000, a wearable defibrillator that was supposed to protect against sudden cardiac arrest. 

Although the manufacturer implemented corrective actions following a recall several years ago, serious concerns remain about whether those measures truly addressed the underlying danger.

The FDA closed its review of the manufacturer’s corrective actions in August 2021, meaning the issue was considered resolved from a regulatory perspective, but users’ problems with the LifeVest 4000 didn’t stop. 

And after this recent tragedy, new questions have been raised: Did patients continue to be at risk? Were the warnings inadequate? Were users not properly informed about device behavior that could indicate failure?

These and other concerns have resurfaced in the wake of a devastating loss for the family we represent. 

This can no longer be considered an old problem. It’s a current and urgent one. If you or a loved one were harmed during use of the ZOLL LifeVest, contact Morgan & Morgan today for a free case evaluation to learn more about your legal options.

What Went Wrong With the ZOLL LifeVest 4000

The LifeVest 4000, designed for patients 18 and older who are at risk for sudden cardiac arrest but not candidates for an implantable defibrillator, depends on internal software checks to detect critical defects. 

ZOLL discovered that the device could display a “Call for service – Message Code 102” without properly identifying underlying issues that could prevent it from delivering a life-saving shock.

In other words: the device might not work when the patient needed it most.

This flaw affected every serial number of the LifeVest Model 4000—over 33,000 units in circulation.

How Patients Were Instructed to Respond and What Was Never Addressed

ZOLL issued safety notices telling patients that if Message Code 102 appeared, they should call for a replacement immediately, but the concern then and now is whether:

• Patients were given clear, prominent, and repeated warnings
• The alert system was strong enough to get patients’ attention
• Users fully understood that Message Code 102 could signal a complete inability to deliver therapy
• Anyone wearing a LifeVest 4000 was unknowingly at risk, even without seeing the code

Morgan & Morgan believes those questions were never fully resolved, and lives may have been endangered as a result.

Why This Still Matters Today

Life-saving medical devices must work every time. A wearable defibrillator is not like any other consumer product. Its entire purpose is to intervene in the split second between survival and catastrophe.

When patients trust a device to protect them and it fails, the consequences are catastrophic. Tragically, that is exactly what happened in the case now being handled by Morgan & Morgan.

Our litigation argues that:

• The manufacturer’s fixes were insufficient
• Risks persisted long after the FDA closed its file
• Users were not adequately informed of dangers or device limitations
• Patients and families may have suffered preventable harm

What You Can Do

For many, a device like the ZOLL LifeVest was intended as a lifeline, but when that lifeline fails, the consequences can be devastating. 

Patients who suffered cardiac emergencies while wearing a defective LifeVest may have been left unprotected through no fault of their own.

Medical device manufacturers have a legal and moral duty to ensure their products are safe, reliable, and properly tested before they reach patients. When they fail to do so, and patients are harmed as a result, they can be held accountable.

If you or a loved one suffered injury or if a loved one passed away, after wearing a ZOLL LifeVest 4000, you may be entitled to compensation for:

• Medical expenses and hospital bills
• Pain and suffering
• Loss of income or earning ability
• Wrongful death damages (for surviving family members)

Morgan & Morgan’s product liability attorneys have decades of experience taking on major manufacturers when their negligence puts lives at risk. We have the resources and national reach to investigate complex recalls, analyze FDA filings, and fight for justice on behalf of those who trusted a product that failed them.

Contact Morgan & Morgan if You Need Help

If you were affected by the ZOLL LifeVest recall, don’t wait to get answers. Contact Morgan & Morgan today for a free, no-obligation case evaluation. Our attorneys work For the People, not the powerful corporations that put profits before safety. Hiring one of our lawyers is easy, and you can get started in minutes now.