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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Communicator

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  Class 2 Device Recall LATITUDE Communicator see related information
Date Initiated by Firm August 07, 2009
Date Posted November 12, 2009
Recall Status1 Terminated 3 on December 04, 2012
Recall Number Z-0180-2010
Recall Event ID 53083
PMA Number P910077S092 
Product Classification Implantable cardioverter defibrillator - Product Code LWS
Product Guidant LATITUDE¿ Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE¿ Patient Management system enables physicians to periodically monitor both patient and device status remotely.

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 SERIAL NUMBERS:  029251, 064452, 059718, 064001, 056441, 059851, 070188, 072291, 312706, 305339, 312762, 004610, 024762, 049668, 061205, 067781, 051788, 056069, 068447, 069808, 008653, 068085, 057090, 023576, 028974, 017638, 603254, 064457, 069473, 069902, 071065, 072021, 073621, 073837, 312707, 605519,  603234, 603788, 072396, 059662, 056346, 301645, 312781, 307327, 067067,  055853, 060274, 605304, 305344, 302301, 605981, 009271, 056500, 300895,  602642, 030830, 301117, 055001, 049660, 047455, 056923, 309556, 044034,  063667, 005931, 067765, 063012, 050130, 051267, 055558, 060325, 060973,  063034, 306808, 306852, 309355, 041156, 062922, 063064, 061177, 300499,  039398, 039401, 039403, 060619, 065476, 058913, 056802, 073812  024833, 073560, 606104, 606288, 606604, 606826, 607180 608231 and 607180.    
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		 The L ATITUDE¿ communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It
FDA Determined
Cause 2		 Software design
Action Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling 1-651-582-4000.
Quantity in Commerce 97
Distribution Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, 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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