Boston Scientific recalls 55cm spinal cord stimulation extension kits with incorrect use by dates. No health risks expected but removal advised due to potential labeling error.
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 55 cm spinal cord stimulation extension kits that have an incorrect use by date label. This issue does not cause health risks but requires removal to prevent potential confusion with expiration dates.
The extension kits have a use by date label that is later than the correct expiration date. This labeling error could cause confusion about when the device should be used, but no health risks are expected from this issue.
Patients using spinal cord stimulation devices with these specific extension kits are affected. Those with the kits listed in the serial numbers are most at risk.
Check for the part number M365SC3138550 on the kit. The specific serial numbers listed in the recall include 1044463, 1066242, 3003060, and other numbers provided in the recall notice.
Look for the part number M365SC3138550 on the extension kit.
No health risks are expected from this labeling error. The recall is for potential confusion with expiration dates.
Check for the part number M365SC3138550 and the specific serial numbers listed in the recall notice.
The recall does not require action since no health risks are expected. However, the manufacturer recommends checking the label for correct use by dates.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2124-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2124-2020 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.
