Boston Scientific recalls 55cm 8-contact DBS extension kits with incorrect use-by dates. No health risks expected. Affected units have specific serial numbers.
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "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 55cm 8-contact extension kits for deep brain stimulation systems due to an incorrect use-by date label. This issue does not pose a health risk but requires replacement of the affected units.
The extension kits have a use-by date label that is later than the correct expiration date. This labeling error means the product could be used beyond its intended shelf life, though no health risks are expected.
Patients with deep brain stimulation (DBS) systems using the specific 55cm extension kits are affected. Those with the listed serial numbers are most at risk.
Check for the part number M365NM3138550 on the extension kit. Affected units have specific serial numbers: 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225, and 3012324.
Compare your extension kit's serial number with the list: 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225, and 3012324.
No adverse health consequences are expected from this issue.
Check your serial number against the list provided in the recall notice.
Look for the part number M365NM3138550 and check if your serial number matches the listed numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2125-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2125-2020 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.
