FDA Medical Device Recalls (openFDA)
Medtronic,Inc/Rice Creek Facil: Atakr II RF Power Generator, Models 4802 and 4803
- Recall number
- Z-0618-03
- Recalling firm
- Medtronic,Inc/Rice Creek Facil
- Product
- Atakr II RF Power Generator, Models 4802 and 4803
- Status
- Terminated
- Initiated
- 2002-11-25
- Posted
- 2003-03-06
- Terminated
- 2003-11-04
- Reason
- An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.
- Root cause
- Other
- Action
- An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem.
- Quantity
- 775 units
- Distribution
- not on file
- Lot, serial or model codes
- All units
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 2182208
- Firm city
- Fridley
- Firm state
- MN
- 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