Life-Saving Devices That May Fail When You Need Them Most: What You Need to Know About the ZOLL LifeVest Recall

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. 

The device, which has been the subject of a nationwide recall, allegedly failed to deliver a life-saving shock when it was needed most. Sadly, this case highlights exactly what can happen when patients place their trust in a defective medical device—and that trust is betrayed.

What Happened With the ZOLL LifeVest Recall

On September 12, 2017, ZOLL Manufacturing Corporation initiated a recall of its LifeVest Wearable Defibrillator Model 4000 (Product Number 10A0988-A01) after discovering a software defect that could prevent the device from delivering a defibrillation shock when needed. The issue stemmed from an incorrect service code that failed to catch critical defects during self-checks.

The FDA classified the issue under Recall Number Z-0353-2018, noting the potential for defibrillation shock failure. This malfunction could mean the difference between life and death for patients relying on the device.

The Defect and the Impact

The recall applied to all serial numbers of the LifeVest 4000, impacting roughly 33,670 units in circulation across the U.S. The device was intended for patients 18 years and older who were at risk for sudden cardiac arrest but were not candidates for or had refused an implanted defibrillator.

Because the LifeVest is typically worn around the clock, patients trusted it as a constant safeguard. Unfortunately, the defect meant that in some cases, the system might not deliver the therapy it was designed for, leaving wearers vulnerable at the most critical moments.

The Manufacturer’s Response

ZOLL initially notified patients of the issue through a patient safety alert on September 12, 2017, delivered via courier service to all active users. Patients were instructed to pay close attention to “Call for service – Message Code 102” on their device screens.

If that message appeared, it meant that LifeVest might not deliver therapy if needed, and patients were urged to contact ZOLL immediately at 1-800-543-3267 for a replacement unit, which the company promised to provide within 24 hours.

In January 2019, ZOLL released a new software update approved by the FDA that made the “Call for Service” alerts more prominent and persistent. The company began replacing all affected devices over a 3.5-month period, instructing patients to continue using their LifeVests as prescribed until they received the updated version.

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.

Even though this recall was terminated by the FDA in August 2021, meaning the corrective actions were considered complete, questions remain about whether all patients were adequately warned, trained, or protected during the recall period.

In short, 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.