Boston Scientific recalls DYNAGEN EL ICD DR Model D152 devices that may download unapproved software updates via Model 3300 programmers, potentially causing safety issues.
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Boston Scientific is recalling DYNAGEN EL ICD DR Model D152 implantable defibrillators that could download unapproved software updates through Model 3300 programmers. This poses a risk of potential safety issues due to unauthorized software applications.
The software update application directed Model 3300 programmers to download unapproved software applications that haven't been approved by the US Food and Drug Administration. This could lead to potential safety issues with the device.
Patients with Boston Scientific DYNAGEN EL ICD DR Model D152 implantable defibrillators are affected. Those using Model 3300 programmers for device updates may be at higher risk.
Check for the DYNAGEN EL ICD DR Model D152 label on your implantable defibrillator. The serial number 516959 is associated with this recall.
Verify your implantable defibrillator model is DYNAGEN EL ICD DR Model D152.
The software update application directed Model 3300 programmers to download unapproved software applications that haven't been approved by the US Food and Drug Administration.
Check for the DYNAGEN EL ICD DR Model D152 label on your implantable defibrillator. The serial number 516959 is associated with this recall.
The recall record does not specify a remedy or action steps for affected devices.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1512-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1512-2020 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.
