Boston Scientific recalls EMBLEM S-ICD Model A209 devices with specific serial numbers due to electrical overstress potentially causing device malfunction. Affected units include 100+ serial numbers listed. Consumers should check their device.
Electrical overstress may lead to device malfunction.
Boston Scientific is recalling EMBLEM S-ICD Model A209 devices with specific serial numbers because electrical overstress could cause device malfunction. This recall affects approximately 100 devices. If you own one of these models, you should check your serial number against the list provided.
Electrical overstress in the device could lead to malfunction, which might cause the device to not function properly. This is a potential issue but does not indicate immediate danger to health or safety.
Individuals who own the EMBLEM S-ICD Model A209 device with the listed serial numbers are affected. Patients with this device are most at risk due to potential malfunction.
Check your EMBLEM S-ICD Model A209 device's serial number against the list of 100+ serial numbers provided in the recall notice. The device is a medical implant.
Compare your device's serial number with the list of 100+ serial numbers provided in the recall notice.
The device may malfunction due to electrical overstress, but it is not immediately dangerous. Check your serial number against the list to see if it is affected.
Check your serial number against the list of affected serial numbers provided in the recall notice. If affected, you should contact Boston Scientific for further instructions.
The recall affects 100+ devices with specific serial numbers listed in the notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0950-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0950-2021 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.
