Boston Scientific recalls Model 3300 LATITUDE Programming Systems with specific software versions due to potential flat line during EGM trace channel changes. Affected units have listed serial numbers; contact for remedy.
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.
Boston Scientific is recalling Model 3300 LATITUDE Programming Systems with certain software versions because changing an EGM trace channel during a Manual Pace Threshold test might cause the trace channel to show a flat line. This could lead to incorrect heart rhythm monitoring.
If a user changes an EGM trace channel while a Manual Pace Threshold test is active, the trace channel may switch to a flat line. This could cause inaccurate heart rhythm readings during monitoring.
Users of the Model 3300 LATITUDE Programming System with specific software versions and serial numbers listed in the recall are affected. Medical professionals using the system for cardiac monitoring are most at risk.
Check if your Model 3300 LATITUDE Programming System has the listed serial numbers: 009494, 012689, 010356, 008206, 008124, 007983, 004813, 010751. The system must have Model 3892 v1.04 software installed.
Verify your Model 3300 LATITUDE Programming System has one of the listed serial numbers: 009494, 012689, 010356, 008206, 008124, 007983, 004813, 010751.
Model 3892 v1.04 software is installed on the affected Model 3300 LATITUDE Programming Systems.
Check if your system has one of the listed serial numbers: 009494, 012689, 010356, 008206, 008124, 007983, 004813, 010751.
The recall record does not specify a remedy; contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0319-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0319-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
