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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 Recall
LATITUDE Patient Management System Communicator
see related information
Date Posted March 01, 2012
Recall Status1 Terminated on July 05, 2012
Recall Number Z-1135-2012
Recall Event ID 61107
Premarket Approval
PMA Number
P910077/S110
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
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.
Code Information SN 224453
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Consumer Instructions Contact the recalling firm for information
Manufacturer 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
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC-CRM
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