Z-0353-2018Class II

LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for...

Name: Z-0353-2018 LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for...
Creator: Zoll Manufacturing Corp.
Published: 2017-09-12
License: https://open.fda.gov/license/

ZOLL Manufacturing Corporation / initiated 2017-09-12 / Terminated

FDA source

Zoll Manufacturing Corp. began a recall of 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... on 2017-09-12. FDA classified it as Class II and gives the reason as "Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0353-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Posted: 2018-01-14
Terminated: 2021-08-10
Recalling firm: ZOLL Manufacturing Corporation
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.
Product code: MVK Wearable Automated External Defibrillator
Reason for recall: Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
FDA root 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
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0353-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0353-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-14

Product code MVK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)