Z-3183-2011

LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is...

Name: Z-3183-2011 LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is...
Creator: Boston Scientific CRM Corp
Published: 2011-05-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-05-25 / Terminated / root cause: design

FDA source

Boston Scientific CRM Corp began a recall of LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use to remotely communicate with a... on 2011-05-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3183-2011
Status: Terminated
Initiated: 2011-05-25
Posted: 2011-09-09
Terminated: 2012-12-04
Recalling firm: Boston Scientific Corporation
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.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: 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 tag: design
FDA 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 in commerce: 2
Distribution: Nationwide Distribution-in the states of Florida and Texas.
Product codes and lots: SN 035074 SN 032915

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)