FDA Medical Device Recalls (openFDA)
St Jude Medical: Pulse Generator
- Recall number
- Z-0052-04
- Recalling firm
- St Jude Medical
- Product
- Pulse Generator
- Status
- Terminated
- Initiated
- 2003-07-31
- Posted
- 2003-10-24
- Terminated
- 2004-03-26
- Reason
- Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
- Root cause
- Other
- Action
- Sales Representatives will personally contact the physicians, explain the situation, leave a technical memo and a list of implanted patients for the doctor to follow-up with. The ''Dear Doctor'' letter to accompany the representatives is dated 7/31/2003. Instruments not implanted will be returned for reprocessing.
- Quantity
- 775
- Distribution
- Nationwide and to four VA Medical Centers in IA and MO.
- Lot, serial or model codes
- Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456
- 510(k) numbers
- not on file
- PMA numbers
- ["P880086"]
- Product code
- DXY
- 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