• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Latitude Patient Management System Communicator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Latitude Patient Management System Communicator
see related information
Date Posted April 20, 2012
Recall Status1 Terminated on August 02, 2012
Recall Number Z-1445-2012
Recall Event ID 61390
Premarket Approval
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, Minnesota 55112-5700
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Boston Scientific LATITUDE¿ Patient Management System Communicators were shipped to the incorrect patients.
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 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 Applicant = BOSTON SCIENTIFIC
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC CLONMEL LIMITED
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC CORPORATION
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC CORPORATION (BSC)
PMAs with Product Code = LWS and Applicant = BOSTON SCIENTIFIC-CRM
PMAs with Product Code = LWS and Applicant = CARDIAC PACEMAKERS, INC.
PMAs with Product Code = LWS and Applicant = GUIDANT CORP.
-
-