FDA Medical Device Recalls (openFDA)
Biotronik Inc: Tachos DR - Implantable Cardioverter Defibrillator
- Recall number
- Z-0941-04
- Recalling firm
- Biotronik Inc
- Product
- Tachos DR - Implantable Cardioverter Defibrillator
- 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
- 363
- 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 335 572 Serial numbers: 78011709 - 78011712, 78011714 ¿ 78011719, 78011725 ¿ 78011729, 78011759 ¿ 78011763, 78011769 ¿ 78011778, 78011780 ¿ 78011791, 78011793 - 78011829, 78011831, 78011833 ¿ 78011864, 78011866 ¿ 78011928, 78011930 ¿ 78011937, 78011939 ¿ 78011949, 78011951 ¿ 78011981, 78011983 ¿ 78011985, 78011987 ¿ 78011988, 78019000 -78019014, 78019016 ¿ 78019025, 78019027, 78019029 ¿ 78019035, 78019037 ¿ 78019051, 78019053 ¿ 78019066, 78019068 ¿ 78019081, 78019083, 78019084, 78019086 ¿ 78019091, 78019096 ¿ 78019099, 78019101 ¿ 78019105, 78019107 ¿ 780190122, 78019126 ¿ 780190129, 78019131 ¿ 78019140
- 510(k) numbers
- not on file
- PMA numbers
- ["P000009/S1"]
- 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