Boston Scientific recalls Artisan 70cm 2x8 Surgical Lead Kits with incorrect use by dates. No health risks expected. Consumers should check product labels for part number M365SC8216700 and serial numbers 632107 or 645608.
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 certain spinal cord stimulation lead kits due to an incorrect 'use by date' label. This issue does not pose a health risk but requires replacement to ensure proper product function.
The label shows a 'use by date' that is later than the correct date. This means the leads may expire before the intended use, potentially causing improper function in spinal cord stimulation systems. However, no adverse health effects are expected from this issue.
Medical professionals who own or use the specific Artisan 70cm 2x8 Surgical Lead Kit with part number M365SC8216700 and serial numbers 632107 or 645608. Patients using spinal cord stimulation systems are least at risk as no health consequences are expected.
Check for the part number M365SC8216700 on the label. Look for serial numbers 632107 or 645608. The product is a 70 cm 2 x 8 Surgical Lead Kit used in spinal cord stimulation systems.
Look for part number M365SC8216700 and serial numbers 632107 or 645608 on the label.
No adverse health consequences are expected from this issue.
Check the product label for part number M365SC8216700 and serial numbers 632107 or 645608. Boston Scientific is voluntarily recalling these items for replacement.
The affected products have part number M365SC8216700 and serial numbers 632107 or 645608.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2119-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2119-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
