Biotronik Inc Tachos DR - Atrial Tx Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tachos DR - Atrial Tx
Brand
Biotronik Inc
Lot Codes / Batch Numbers
Model Number 122 499 Serial numbers: 78012522, 78012524, 78012525, 78012548, 78012675, 78012677, 78012681, 78012683, 78012707, 78012709 ¿ 78012712, 78012714, 78012715, 78012718, 78012719, 78012763, 78012767, 78012768, 78012771, 78012791, 78012792, 78012794, 78012804, 78012809, 78012815 ¿ 78012820, 78012968, 78012987 ¿ 78012989, 78013072 ¿ 78013076, 78013092 ¿ 78013094, 78013099, 78013100, 78013165 ¿ 78013185, 78013194, 78013198, 78013200 ¿ 78013204, 78013206, 78013207, 78013210, 78013217 ¿ 78013220, 78013222, 78013224 ¿ 78013227, 78013230 ¿ 78013256, 78013258 ¿ 78013262, 78013278, 78013282, 78013284, 78013285, 78013292, 78013297, 78013299, 78013315, 78013317, 78013321
Products Sold
Model Number 122 499 Serial numbers: 78012522, 78012524, 78012525, 78012548, 78012675, 78012677, 78012681, 78012683, 78012707, 78012709 ¿ 78012712, 78012714, 78012715, 78012718, 78012719, 78012763, 78012767, 78012768, 78012771, 78012791, 78012792, 78012794, 78012804, 78012809, 78012815 ¿ 78012820, 78012968, 78012987 ¿ 78012989, 78013072 ¿ 78013076, 78013092 ¿ 78013094, 78013099, 78013100, 78013165 ¿ 78013185, 78013194, 78013198, 78013200 ¿ 78013204, 78013206, 78013207, 78013210, 78013217 ¿ 78013220, 78013222, 78013224 ¿ 78013227, 78013230 ¿ 78013256, 78013258 ¿ 78013262, 78013278, 78013282, 78013284, 78013285, 78013292, 78013297, 78013299, 78013315, 78013317, 78013321
Biotronik Inc is recalling Tachos DR - Atrial Tx due to Potential for device to not deliver full amount of energy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for device to not deliver full amount of energy
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026