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

Class 3 Device Recall Boston Scientific, 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 3 Recall
Boston Scientific, LATITUDE Patient Management System Communicator
see related information
Date Posted September 28, 2011
Recall Status1 Terminated on November 06, 2012
Recall Number Z-3283-2011
Recall Event ID 59686
Premarket Approval
PMA Numbers
P910077/S051 P910077/S090
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 196181 6476 196183 6476 196184 6476 196187 6476 196188 6476 196189 6476 196192 6476 196194 6476 196196 6476 196220 6476 196223 6476 196228 6476 196231 6476 196237 6476 196238 6476 196240 6476 196244 6476 196247 6476 196253 6476 196256 6476 196270 6476 196295 6476 196307 6476 196347 6476 196350 6476 196353 6476 196354 6476 196356 6476 196361 6476 196365 6476 196368 6476 196369 6476 196371 6476 196375 6476 196376 6476 198243 6476 198293 6476 198304 6476 198485 6476 198487 6476 198502 6476 198512 6476 198515 6476 198516 6476 198873 6476 198881 6476 198888 6476 198890 6476 199443 6476 199444 6476 199446 6476 199447 6476 199448 6476 199449 6476 199450 6476 199451 6476 199452 6476 199453 6476 199454 6476 199455 6476 199456 6476 199457 6476 199458 6476 199459 6476 199460 6476 199464 6476 199465 6476 199467 6476 199468 6476 199470 6476 199471 6476 199473 6476 199474 6476 199476 6476 199485 6476 199488 6476 199489 6476 199491 6476 199501 6476 199503 6476 199504 6476 199507 6476 199508 6476 199509 6476 199510 6476 199511 6476 199512 6476 199513 6476 199514 6476 199515 6476 199516 6476 199517 6476 199518 6476 199519 6476 199520 6476 199521 6476 199522 6476 199523 6476 199524 6476 199525 6476 199526 6476 199527 6476 199528 6476 199529 6476 199530 6476 199531 6476 199532 6476 199533 6476 199534 6476 199535 6476 199536 6476 199537 6476 199538 6476 199544 6476 199552 6476 199557 6476 199562 6476 199565 6476 199568 6476 199569 6476 199570 6476 199571 6476 199572 6476 199573 6476 199574 6476 199575 6476 199576 6476 199577 6476 199578 6476 199579 6476 199580 6476 199581 6476 199582 6476 199583 6476 199584 6476 199585 6476 199586 6476 199587 6476 199588 6476 199589 6476 199590 6476 199591 6476 199592 6476 199593 6476 199594 6476 199595 6476 199596 6476 199597 6476 199598 6476 199600 6476 199601 6476 199602 6476 199603 6476 199606 6476 199607 6476 199608 6476 199609 6476 199610 6476 199611 6476 199612 6476 199613 6476 199615 6476 199618 6476 199621 6476 199624 6476 199627 6476 199642 6476 199660 6476 199661 6476 199663 6476 199664 6476 199665 6476 199666 6476 199667 6476 199668 6476 199669 6476 199670 6476 199671 6476 199672 6476 199673 6476 199674 6476 199675 6476 199676 6476 199677 6476 199678 6476 199679 6476 199680 6476 199681 6476 199682 6476 199683 6476 199684 6476 199685 6476 199686 6476 199687 6476 199688 6476 199719 6476 199720 6476 199721 6476 199722 6476 199723 6476 199724 6476 199725 6476 199726 6476 199727 6476 199728 6476 199729 6476 199730 6476 199731 6476 199732 6476 199733 6476 199734 6476 199735 6476 199736 6476 199737 6476 199738 6476 199739 6476 199740 6476 199741 6476 199742 6476 199743 6476 199744 6476 199745 6476 199746 6476 199747 6476 199748 6476 199749 6476 199750 6476 199751 6476 199752 6476 199753 6476 199754 6476 199755 6476 199756 6476 199757 6476 199758 6476 199759 6476 199760 6476 199761 6476 199762 6476 199763 6476 199764 6476 199765 6476 199766 6476 199767 6476 199768 6476 199769 6476 199770 6476 199771 6476 199772 6476 199773 6476 199774 6476 199775 6476 199776 6476 199777 6476 199778 6476 199845 6476 199846 6476 199847 6476 199848 6476 199849 6476 199850 6476 199851 6476 199852 6476 199853 6476 199854 6476 199855 6476 199856 6476 199857 6476 199858 6476 199859 6476 199860 6476 199861 6476 199862 6476 199863 6476 199864 6476 199865 6476 199866 6476 199867 6476 199868 6476 199869 6476 199870 6476 199871 6476 199872 6476 199873 6476 199874 6476 199875 6476 199876 6476 199877 6476 199878 6476 199879 6476 199880 6476 199881 6476 199882 6476 199883 6476 199884 6476 199885 6476 199886 6476 199887 6476 199888 6476 199889 6476 199890 6476 199891 6476 199892 6476 199893 6476 199894 6476 199895 6476 199896 6476 199897 6476 199898 6476 199899 6476 199900 6476 199901 6476 199902 6476 199903 6476 199904 6476 199920 6476 199921 6476 199922 6476 199923 6476 199924 6476 199925 6476 199926 6476 199929 6476 199930 6476 199932 6476 199933 6476 199966 6476 199967 6476 199969 6476 199970 6476 199972 6476 199973 6476 199975 6476 199976 6476 199978 6476 199979 6476 199982 6476 199984 6476 199985 6476 199986 6476 199987 6476 199988 6476 199990 6476 199991 6476 199993 6476 199994 6476 199995 6476 199998 6476 200001 6476 200004 6476 200007 6476 200010 6476 200013 6476 200016 6476 200019 6476 200022 6482 045402 6482 045406 6482 045411 6482 045423 6482 045431 6482 045436 6482 045441
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
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
DESIGN: Software Design (Manufacturing Process)
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 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 = GUIDANT CORP.
-
-