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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly states that no adverse health consequence is expected to occur, and the issue is limited to a labeling error 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 is later than the correct 'use by date'.
The affected products include the LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. The specific units involved have serial numbers 1039736, 1039779, and 1042340. These leads function as components of Boston Scientific's Spinal Cord Stimulation (SCS) 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 affected units were distributed outside the United States to 14 countries.
The recalled product
- Product
- LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inh
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 3
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 (4)
- Part number M365SC2352500
- serial numbers 1039736
- 1039779
- and 1042340.
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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