Boston Scientific recalls 35cm spinal cord stimulation extension kits with incorrect use by dates. No health risks expected from this 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 35cm spinal cord stimulation extension kits that have an incorrect 'use by date' label. This labeling error means the product might be used beyond its intended shelf life, but no health risks are expected.
The extension kits have a 'use by date' label that is later than the correct expiration date. This could mean the product is used beyond its intended shelf life, but the recall states no adverse health consequences are expected.
Patients using spinal cord stimulation systems for chronic pain management may own these kits. Those with the specific part numbers listed are most at risk.
Check for part number M365SC3138350 on the kit. The affected kits have specific serial numbers including 1041034, 1055172, and others listed in the recall notice.
Verify the part number and serial numbers listed in the recall notice to confirm if your kit is affected.
No, the recall states no adverse health consequences are expected from this labeling error.
Check the part number and serial numbers listed in the recall notice to see if your kit is affected. If it is, you don't need to take any action beyond checking.
Look for part number M365SC3138350 and the specific serial numbers listed in the recall 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-2120-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2120-2020 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.
