Lower risk Medical device recall · FDA · Published September 22, 2020

Boston Scientific Model 3300 LATITUDE Programming System Recall: Risk of Flat Line During

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0319-2021Medical device Boston Scientific ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N Bldg 3 · Saint Paul, MN 55112-5700

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/64232-boston-scientific-model-3300-latitude-programming-system-recall-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/64232-boston-scientific-model-3300-latitude-programming-system-recall-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0319-2021

Cite this page

“Boston Scientific Model 3300 LATITUDE Programming System Recall: Risk of Flat Line During.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64232-boston-scientific-model-3300-latitude-programming-system-recall-risk-of. Based on FDA recall #Z-0319-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0319-2021%22&limit=1).

The FDA announced on 2020-09-22 that Boston Scientific Corporation is recalling eight Model 3300 LATITUDE Programming Systems due to a potential flat-line trace channel hazard. The recall covers units with specific serial numbers distributed in Arkansas, Florida, Illinois, and Texas.

How to tell if you have it

Boston Scientific Model 3300 LATITUDE Programming System
Installed Software: Model 3892 ALTRUA, INSIGNIA I, NEXUS I
Software Version: Model 3892 v1.04
Serial Numbers: 009494, 012689, 010356, 008206, 008124, 007983, 004813, 010751

The hazard

According to the 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.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since 2017-06-01. Recent brand recalls include the 2026-08-24 Imager II Angiographic Catheters Recall for Tip Fracture Risk, the 2026-08-06 LUX-Dx Cardiac Monitor System Recall for Delayed AF Burden Alerts, and the 2026-07-22 StoneSmart Connect Console Power Adapters recall for safety testing failures. Other recent recalls of similar products include the 2026-07-01 Philips Cardiac Workstation 5000 Inaccurate Heart Rate Data Risk, the 2026-07-01 Philips Cardiac Workstation 7000 Inaccurate Heart Rate Data Risk, and the 2026-07-20 Midmark ECG Devices May Show Incorrect Heart Rhythm Readings.

How to tell if you have this one

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.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify your Model 3300 LATITUDE Programming System has one of the listed serial numbers: 009494, 012689, 010356, 008206, 008124, 007983, 004813, 010751.

Where it went and when

Where it was distributed

Distributed in 4 states.

FDA distribution: “Distributed in US - AR, FL, IL, and TX” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, Florida, Illinois, Texas.

Recall timeline

FDA terminated this recall 4 years after the firm started it.

Sep 22, 2020Firm started the recall
Oct 31, 2020FDA classified it Class II
Nov 11, 2020Published in FDA’s Enforcement Report
Sep 4, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64232-boston-scientific-model-3300-latitude-programming-system-recall-risk-of">Boston Scientific Model 3300 LATITUDE Programming System Recall: Risk of Flat Line During (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0319-2021 (September 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0319-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.