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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE

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  Class 2 Device Recall LATITUDE see related information
Date Initiated by Firm September 22, 2020
Create Date October 31, 2020
Recall Status1 Completed
Recall Number Z-0319-2021
Recall Event ID 86534
PMA Number P910077S178 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
Product Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Code Information Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
Manufacturer Reason
for Recall		 There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
FDA Determined
Cause 2		 Software design
Action Boston Scientific sales representatives will hand-deliver a removal letter to all customer consignees with one of the eight affected Model 3300 LATITUDE programmer. BSC sales representatives will maintain control of these devices. In order to continue to provide the benefits that this software support application provides for those patients implanted with an ALTRUA/INSIGNIA I pacemaker, BSC sales representatives will continue to use Model 3300 LATITUDE programmers installed with the Model 3892 v1.04 ALTRUA / INSIGNIA I / NEXUS I Software Support Application in the field. The risks associated with this unintended behavior can be avoided when specific remedial actions are adhered to. These remedial actions will be adhered to until a software correction is approved and installed on these programmers. BSC will confirm via email from sales representatives that 100% of the removal letters were delivered. BSC will post the removal letter on the BSC website within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html.
Quantity in Commerce 8 devices
Distribution Distributed in US - AR, FL, IL, and TX
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.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC
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