Boston Scientific recalls Model 3300 LATITUDE Programming System with potential for unintended cross-chamber stimulation. Affected units have specific serial numbers. Consumers should contact Boston Scientific for details.
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Boston Scientific is recalling Model 3300 LATITUDE Programming Systems that may cause unintended cross-chamber stimulation. This could lead to improper heart rhythm treatment if the device is used incorrectly. Affected units have specific serial numbers listed in the recall notice.
The Pacing System Analyzer (PSA) in the programming system may send electrical signals to the wrong chamber of the heart. This could cause improper heart rhythm treatment or unintended heart stimulation if the system is used without proper settings.
Healthcare professionals using the Model 3300 LATITUDE Programming System in clinical settings are most at risk. Patients with implantable cardiac devices may be affected if the system is used improperly.
Check if your Model 3300 LATITUDE Programming System has a serial number from the list provided in the recall notice. The system is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems.
Reach out to Boston Scientific directly using the contact information provided in the recall notice to confirm if your unit is affected and get instructions.
The Pacing System Analyzer (PSA) may exhibit unintended cross-chamber stimulation, which could lead to improper heart rhythm treatment.
Check if your Model 3300 LATITUDE Programming System has a serial number from the list provided in the recall notice.
No, but you should contact Boston Scientific to confirm if your unit is affected and get 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-3260-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3260-2018 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.
