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Terminated

Tachos DR - Implantable Cardioverter Defibrillator.

FDA Recall Z-0700-03 · Posted 2003-04-01

Recalling FirmBiotronik Inc
Recall StatusTerminated
Product CodeLWS
Date Initiated2003-02-21
Date Terminated2003-09-08
Product Quantity240 (225 still implanted)

Reason for Recall

Potential for battery to delivery less than full amount of energy.

Firm Action

The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians. This letter explains the issue and recommends scheduling an immediate follow-up with the patients. The letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted.

Root Cause

Other

Distribution Pattern

The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.

Official Source

View FDA Recall →

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

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