Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error
Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source explicitly states that no adverse health consequence is expected to occur, and the issue is limited to a packaging/labeling discrepancy regarding the use-by date, which aligns with the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Boston Scientific Neuromodulation Corporation is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions. The recall is due to a labeling error where the 'use by date' displayed on the product label is later than the correct 'use by date'.
The affected products include the ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. The specific units involved have serial numbers 632107 and 645608. These surgical paddle leads function as a component of Boston Scientific's spinal cord stimulator systems by delivering electrical stimulation to nerve structures in the dorsal aspect of the spinal cord to inhibit pain sensation.
The firm states that no adverse health consequence is expected to occur from this issue. The products were distributed to 14 countries outside the United States. Consumers and healthcare providers should check their inventory for these specific part and serial numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1)…
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part number M365SC8216700
- serial numbers 632107 and 645608
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Boston Scientific Neuromodulation Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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