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Terminated

Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.

FDA Recall Z-0077-04 · Posted 2003-10-31

Recalling FirmBiotronik Inc
Recall StatusTerminated
Product CodeLWS
Date Initiated2003-09-24
Date Terminated2005-02-17
Product Quantity272 devices

Reason for Recall

Potential for early depletion of Implantable Cardioverter Defibrillator battery.

Firm Action

Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices.

Root Cause

Other

Distribution Pattern

The firm distributes to physicians located throughout the US.

Official Source

View FDA Recall →

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

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