Boston Scientific recalls certain spinal cord stimulation leads with incorrect use by dates. No health risks expected. Consumers should check product labels for part number M365SC2352700.
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 requires replacement to ensure proper product safety.
The label shows a later 'use by date' than the correct date. This means the leads might expire before intended use, though no health risks are expected.
Patients using spinal cord stimulation systems for chronic pain management may own this product. Those with the specific part number M365SC2352700 are most at risk.
Check for the part number M365SC2352700 on the lead kit label. The product was sold as part of spinal cord stimulation systems for chronic pain management.
Look for the part number M365SC2352700 on the lead kit label.
No adverse health consequences are expected from this issue.
Check for part number M365SC2352700 on the lead kit label.
No, the recall does not require stopping use but requires checking the label for the correct part number.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2122-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2122-2020 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.
