Class 2 Device Recall LifeVest Wearable Defibrillator

• Date Initiated by Firm: September 12, 2017
• Date Posted: January 14, 2018
• Recall Status: Terminated on August 10, 2021
• Recall Number: Z-0353-2018
• Recall Event ID: 78926
• PMA Number: P010030
• Product Classification: Wearable automated external defibrillator - Product Code MVK
• 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.
• Code Information: All Serial Numbers
• Recalling Firm/ Manufacturer: Zoll Manufacturing Corp.; 121 Gamma Dr; Pittsburgh PA 15238-2919
• For Additional Information Contact: Zoll Technical Support; 800-543-3267
• Manufacturer Reason for Recall: Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
• FDA Determined Cause: Other
• Action: On September 14, 2017, ZOLL Manufacturing Corporation issued a patient safety alert notice dated September 12, 2017 to all active patients via courier service. As of November 2, 2017, a copy of this same patient Safety Alert notice is included with all current device shipments. The purpose of the communication is to revise the training patients received about the "Call for service" message. In certain cases, a "Call for service - Message Code 102" could mean that your LifeVest may not be able to deliver therapy if you need it. Users should call ZOLL immediately for a replacement LifeVest if a "Call for service - Message Code 102" appears on the screen. A replacement will be provided within 24 hours. Patients are instructed to continue using the LifeVest as prescribed by their physician. On January 8, 2019, Zoll Manufacturing Corporation issued Urgent Medical Device Correction notices to customers informing all that FDA approved a new software version for the ZOLL LifeVest 4000 that provides enhanced prominence and persistence of patient alerts when a "Call for service---Message Code 102" exists, instructing patients to call ZOLL immediately at 1-800-543-3267 for a replacement LifeVest. All new patients will receive a LifeVest with this new software revision. In addition, over the next 3.5 months, ZOLL will contact all current patients and exchange their monitor for one with this new software. Patients should continue to use the LifeVest as prescribed by their physician during the software rollout and no physician action is required. Customers with questions or concerns, please feel free to contact your ZOLL LifeVest representative or ZOLL Technical Services at 1-800-543-3267.
• Quantity in Commerce: 33,670 units
• Distribution: US Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MVK