Boston Scientific recalls certain spinal cord stimulation leads due to an incorrect use by date label. No health risks expected. Affected units include specific part numbers and 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 specific spinal cord stimulation leads that have an incorrect use by date label. This issue does not pose a health risk, but the company is removing these leads to prevent potential confusion.
The label on the leads shows a use by date that is later than the correct date. This could lead to confusion about when the leads should be replaced, but no health risks are expected from this issue.
Spinal cord stimulation system users who own the recalled lead kits with part number M365SC2352500 and serial numbers 1039736, 1039779, or 1042340. Patients using these leads for pain management are most at risk of confusion.
Check for the part number M365SC2352500 and serial numbers 1039736, 1039779, or 1042340 on the lead kit packaging. These leads are used in spinal cord stimulation systems for pain management.
Look for the part number M365SC2352500 and serial numbers 1039736, 1039779, or 1042340 on the lead kit packaging.
No adverse health consequences are expected from this issue.
The recall does not require immediate action, but you can check the lead kit details to confirm if it is affected.
Check for the part number M365SC2352500 and serial numbers 1039736, 1039779, or 1042340 on the lead kit packaging.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2121-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2121-2020 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.
