Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical specialties.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Boston Scientific is a leading manufacturer of medical devices, specializing in cardiovascular, neurovascular, and other medical specialties. They are known for their innovative products and solutions that improve patient outcomes.
Boston Scientific devices are generally safe and effective, but like all medical devices, they carry some risk of adverse events. The company has a strong safety record and rigorous quality control processes.
Patients using Boston Scientific medical devices, healthcare professionals, and medical facilities
Check for proper device labeling, ensure the device is used according to manufacturer guidelines, and report any adverse events to the appropriate regulatory authority.
Ensure the device is used as directed by the manufacturer
Report any adverse events to the manufacturer or regulatory authorities
Keep records of device usage and maintenance
Yes, Boston Scientific devices undergo rigorous testing and quality control to ensure safety and effectiveness. However, like all medical devices, they carry some risk of adverse events.
You can report device issues to Boston Scientific directly through their customer support or to the appropriate regulatory authority such as the FDA.
Most Boston Scientific devices require regular maintenance and servicing to ensure optimal performance and safety.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1670-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1670-2022 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.