FDA Medical Device Recalls (openFDA)
Biotronik Inc: Tachos DR - Atrial Tx
- Recall number
- Z-0942-04
- Recalling firm
- Biotronik Inc
- Product
- Tachos DR - Atrial Tx
- Status
- Terminated
- Initiated
- 2004-04-29
- Posted
- 2004-07-20
- Terminated
- 2006-04-21
- Reason
- Potential for device to not deliver full amount of energy
- Root cause
- Other
- 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.
- Quantity
- 128
- Distribution
- Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P0000000009/"]
- Product code
- LWS
- Firm FEI
- 1028232
- Firm city
- Lake Oswego
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28