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U.S. Department of Health and Human Services

Class 2 Device Recall Latitude Patient Management System Communicator

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  Class 2 Device Recall Latitude Patient Management System Communicator see related information
Date Initiated by Firm February 24, 2012
Date Posted April 20, 2012
Recall Status1 Terminated 3 on August 02, 2012
Recall Number Z-1445-2012
Recall Event ID 61390
PMA Number P910077 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
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.
Code Information 219329 218900 219316 219304 219367 219372 218958 218842 
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
651-582-4000
Manufacturer Reason
for Recall		 Boston Scientific LATITUDE¿ Patient Management System Communicators were shipped to the incorrect patients.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC
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