Boston Scientific recalls Precision TM M8 Adapter (part M365SC9218150) due to incorrect use by date on label. No health risks expected. Affected units include specific serial numbers for spinal cord pain management devices.
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Boston Scientific is recalling certain Precision TM M8 Adapters used in spinal cord stimulation systems because the label shows an incorrect use-by date. This issue does not cause health risks but requires removal to prevent potential confusion with other products.
The adapter has a label showing a later-than-expected use-by date. This could lead to confusion with other products but does not cause health risks. The issue is purely a labeling error.
Patients using spinal cord stimulation devices for chronic pain management may own this adapter. Those with specific serial numbers 1043743 and 1051329 are most affected.
Check for the part number M365SC9218150 and serial numbers 1043743 or 1051329 on the adapter. The adapter is part of a spinal cord stimulation system for chronic pain management.
Look for the part number M365SC9218150 and serial numbers 1043743 or 1051329 on the adapter.
No health risks are expected from this issue. The problem is a labeling error that does not cause injury.
Check the adapter label for the part number and serial numbers. If they match, contact Boston Scientific for further instructions.
The recall states no adverse health consequences are expected from this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2123-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2123-2020 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.
