Tachos DR - Atrial Tx
FDA Recall Z-0942-04 · Posted 2004-07-20
Recalling FirmBiotronik Inc
Recall StatusTerminated
Product CodeLWS
Date Initiated2004-04-29
Date Terminated2006-04-21
Product Quantity128
Reason for Recall
Potential for device to not deliver full amount of energy
Firm Action
On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.
Root Cause
Other
Distribution Pattern
Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.