FDA Medical Device Recalls (openFDA)
Biotronik Inc: Tachos DR - Atrial TX Implantable Cardioverter Defibrillators
- Recall number
- Z-0702-03
- Recalling firm
- Biotronik Inc
- Product
- Tachos DR - Atrial TX Implantable Cardioverter Defibrillators
- Status
- Terminated
- Initiated
- 2003-02-21
- Posted
- 2003-04-01
- Terminated
- 2003-09-08
- Reason
- Potential for battery to delivery less than full amount of energy
- Root cause
- Other
- 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.
- Quantity
- 49 devices (45 still implanted)
- Distribution
- The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.
- Lot, serial or model codes
- Model No. 122 499 Serial Nos. 78010961, 78012035, 78012076, 78012077, 78012083, 78012090-78012092, 78012103-78012105, 78012109-78012111, 78012117-78012120, 78012122-78012125,78012127, 78012132, 78012163, 78012197, 78012236, 78012292, 78012296, 78012298-78012302, 78012352, 78012354, 78012355, 78012366, 78012369, 78012374, 78012386, 78012413, 78012415, 78012564, 78012652
- 510(k) numbers
- not on file
- PMA numbers
- ["P000009/S4"]
- 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