Z-1445-2012

Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston...

Name: Z-1445-2012 Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston...
Creator: Boston Scientific CRM Corp
Published: 2012-02-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2012-02-24 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific CRM Corp began a recall of Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN... on 2012-02-24. The reason FDA records is "Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1445-2012
Status: Terminated
Initiated: 2012-02-24
Posted: 2012-04-20
Terminated: 2012-08-02
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysia. 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: Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The patients were notified via phone starting on 2/24/12 that their communicator will not be able to activate successfully and that their communicator and sensors will be replaced. If the patient could not be reached via phone or voice mail, a Boston Scientific letter dated 2/29/12 was sent to the patient. The letter described the problem, explained What is a LATITUDE Communicator and What should you do. Questions were directed to Patient Services at (866) 484-3268.
Quantity in commerce: 8
Distribution: Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA.
Product codes and lots: 219329 218900 219316 219304 219367 219372 218958 218842

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)