Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1445-2012 · Posted 2012-04-20

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWS
Date Initiated2012-02-24
Date Terminated2012-08-02
Product Quantity8

Reason for Recall

Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑