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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Programming System

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  Class 2 Device Recall LATITUDE Programming System see related information
Date Initiated by Firm September 10, 2018
Create Date September 27, 2018
Recall Status1 Terminated 3 on September 22, 2021
Recall Number Z-3260-2018
Recall Event ID 81006
PMA Number P910077 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product Model 3300 LATITUDE(TM) Programming System

Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Code Information Serial Numbers: 001343 000488 000903 001404 000923 001352 001441 000203 000224 000255 000284 000434 000441 000445 000501 000515 000519 000521 000534 000536 000546 000553 000578 000588 000601 000602 000605 000606 000609 000610 000616 000617 000620 000628 000631 000633 000634 000636 000637 000638 000643 000644 000661 000664 000666 000667 000669 000671 000673 000677 000679 000682 000688 000690 000691 000700 000710 000717 000719 000720 000723 000726 000746 000757 000765 000924 001125 001556 001562 001564 001571 001574 001615 000598 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
FDA Determined
Cause 2		 Device Design
Action The firm initiated the recall on 09/10/2018 to the US sales representatives by email. The sales representatives were asked to hand deliver the notice to the hospitals when the programmer is retrieved for that location. The sales representatives will electronically confirm the hand delivery of the letter to each affected customer after it occurs.
Quantity in Commerce 74 units
Distribution Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland
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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