FDA Medical Device Recalls (openFDA)
Boston Scientific CRM Corp: LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
- Recall number
- Z-3183-2011
- Recalling firm
- Boston Scientific CRM Corp
- Product
- LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
- Status
- Terminated
- Initiated
- 2011-05-25
- Posted
- 2011-09-09
- Terminated
- 2012-12-04
- Reason
- Boston Scientific has identified two occurrences where the LATITUDE system did not process a data payload, which is the information uploaded to the LATITUDE system from a remote interrogation of the implanted device. These occurrences resulted in non-displayed payloads because the data is not posted to the website. If the payload is not displayed, the pertinent data will not be available on the
- Root cause
- Device Design
- Action
- Boston Scientific notified all affected customers by telephone on May 25, 2011. The customers were informed that there was an interrogation for one of their patients that was not able to be displayed on the website. Boston Scientific detected that a payload failure had occurred, but could not conclude what information was contained within the payload. Each patient has had previous and subsequent payloads that have processed and displayed on the LATITUDE website.
- Quantity
- 2
- Distribution
- Nationwide Distribution-in the states of Florida and Texas.
- Lot, serial or model codes
- SN 035074 SN 032915
- 510(k) numbers
- not on file
- PMA numbers
- ["P910077S051"]
- Product code
- LWS
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- 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