FDA Medical Device Recalls (openFDA)
St Jude Medical: Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343
- Recall number
- Z-0709-05
- Recalling firm
- St Jude Medical
- Product
- Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343
- Status
- Terminated
- Initiated
- 2005-03-10
- Posted
- 2005-04-13
- Terminated
- 2005-07-11
- Reason
- Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery.
- Root cause
- Other
- Action
- Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
- Quantity
- 1488
- Distribution
- Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
- Lot, serial or model codes
- Too numerous to include here.
- 510(k) numbers
- not on file
- PMA numbers
- ["P910023","P030054"]
- Product code
- NIK
- Firm FEI
- 2017865
- Firm city
- Sylmar
- Firm state
- CA
- 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