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Terminated

Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).

FDA Recall Z-1017-05 · Posted 2005-07-19

Recalling FirmSt Jude Medical
Recall StatusTerminated
Product CodeNIK
Date Initiated2005-06-17
Date Terminated2012-03-26
Product Quantity30,000 domestically, 11,684 internationally

Reason for Recall

Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.

Firm Action

Recall was by letter to Physicians sent by FEDEX. Follow-up upgrade to programmers will be done by firm representatives to the new version 4.8.5.

Root Cause

Other

Distribution Pattern

Nationwide and Sweden, Canada, Australia, New Zealand. South America and Asia

Official Source

View FDA Recall →

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

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