FDA Medical Device Recalls (openFDA)
Biotronik Inc: Deikos A+ Implantable Cardioverter Defibrillator
- Recall number
- Z-0701-03
- Recalling firm
- Biotronik Inc
- Product
- Deikos A+ Implantable Cardioverter Defibrillator
- 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
- 7 devices
- 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. 334 341 Serial Nos. 78062821, 78062822, 78062831, 78062838, 78062839, 78062901, 78062957
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- 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