Boston Scientific Corporation Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Boston Scientific Corporation is recalling Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Softwar due to 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 ch. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, FL, IL, IN, TX
Page updated: Jan 10, 2026