Z-1135-2012

Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient...

Name: Z-1135-2012 Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient...
Creator: Boston Scientific CRM Corp
Published: 2012-01-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2012-01-19 / Terminated / root cause: packaging

FDA source

Boston Scientific CRM Corp began a recall of Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient Management system is intended for use to remotely... on 2012-01-19. The reason FDA records is "One (1) Model 6476 LATITUDE Communicator is unable to interrogate the patient's pulse generator. Boston Scientific has determined that this is due to a patient receiving an incorrect communicator. Therefore the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1135-2012
Status: Terminated
Initiated: 2012-01-19
Posted: 2012-03-01
Terminated: 2012-07-05
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: One (1) Model 6476 LATITUDE Communicator is unable to interrogate the patient's pulse generator. Boston Scientific has determined that this is due to a patient receiving an incorrect communicator. Therefore the communicator did not find and was unable to interrogate the assigned patients PG. Additionally when the patient attempted to set-up this incorrect communicator, the system reflected
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On January 19, 2012 Boston Scientific telephoned the affected patient and their clinic. The patient was notified that the communicator they received will not be able to activate successfully and that their communicator and sensors would be replaced. The clinician was informed of the patient's communicator was sent incorrectly to the other patient who attempted to activate it, the monitored status of the website was incorrect and that a new communicator would be shipped to the patient that will work with their device.
Quantity in commerce: 1
Distribution: Nationwide distribution: UT only.
Product codes and lots: SN 224453

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)