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Terminated

Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

FDA Recall Z-0883-2009 · Posted 2009-01-28

Recalling FirmZoll Lifecor Corporation
Recall StatusTerminated
Product CodeMVK
Date Initiated2008-10-21
Date Terminated2009-11-04
Product Quantity1685 units

Reason for Recall

The charging circuit will not shut down properly.

Firm Action

Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.

Root Cause

Component design/selection

Distribution Pattern

Nationwide. OUS: Germany, United Kingdom, Italy, and France.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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