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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific, LATITUDE Patient Management System Communicator

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  Class 3 Device Recall Boston Scientific, LATITUDE Patient Management System Communicator see related information
Date Initiated by Firm August 01, 2011
Date Posted September 28, 2011
Recall Status1 Terminated 3 on November 06, 2012
Recall Number Z-3283-2011
Recall Event ID 59686
PMA Number P910077S051 P910077S090 
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

Boston Scientific, LATITUDE¿ RF Communicator & Software, Model 6482.Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798

LATITUDE Communicator REF 6468 (only distributed outside the US)

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.




Code Information MODEL SERIAL 6476 195543 6476 195544 6476 195550 6476 195555 6476 195556 6476 195557 6476 195560 6476 195562 6476 195563 6476 195566 6476 195701 6476 195707 6476 195708 6476 195711 6476 195713 6476 195717 6476 195722 6476 195725 6476 195726 6476 195727 6476 195728 6476 195729 6476 195733 6476 195734 6476 195735 6476 195736 6476 195739 6476 195740 6476 195742 6476 195744 6476 195748 6476 195749 6476 195751 6476 195764 6476 195765 6476 195767 6476 195768 6476 195769 6476 195770 6476 195773 6476 195775 6476 195776 6476 195780 6476 195783 6476 195786 6476 195797 6476 195800 6476 195803 6476 195867 6476 195870 6476 195872 6476 195876 6476 195909 6476 195910 6476 195911 6476 195914 6476 195915 6476 195916 6476 195919 6476 195922 6476 195923 6476 195924 6476 195928 6476 195929 6476 195930 6476 195934 6476 195938 6476 195977 6476 195980 6476 196034 6476 196052 6476 196083 6476 196086 6476 196167 6476 196170 6476 196171 6476 196172 6476 196173 6476 196174 6476 196177 6476 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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		 A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message.
FDA Determined
Cause 2		 Other
Action Boston Scientific CRM Corporation sent a " Dear Patient", letter dated August 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new communicator is being shipped separately to you with a corrected security certificate that will allow it to be activated and function normally. 1. Please activate this new equipment at your convenience to begin home monitoring. Activation instructions are enclosed with the communicator. 2. We also ask that you return the original communicator previously delivered to you: " Place the original equipment in the shipping box used for the new equipment. " Pack newspaper or other filler around the equipment to prevent damage during shipping, and seal the box. " Enter your address in the FROM section of the prepaid Federal Express label, and apply the return label to the outside of the box directly over the original label. " Call Federal Express at 1.800.463.3339 to schedule a pick-up. We apologize for this inconvenience. If you have further questions, please call 1.866.484.3268.
Quantity in Commerce 470
Distribution Worldwide Distribution -- (USA) nationwide including the states of AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE,NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY., and the countries of United Kingdom, France
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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