Boston Scientific Recalls Spinal Cord Stimulation Lead Extensions Due to Labeling Error
Boston Scientific is voluntarily removing 41 units of spinal cord stimulation lead extensions 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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary removal for a labeling error (incorrect use-by date) where the source explicitly states no adverse health consequence is expected, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Neuromodulation Corporation is voluntarily removing 41 units of the 55 cm 8 Contact Extension Kit (part number M365SC3138550) from the market. These lead extensions are designed to connect percutaneous leads to an Implantable Pulse Generator (IPG) for spinal cord stimulation. The recall was initiated because the 'use by date' displayed on the product label is later than the correct 'use by date'.
The affected products were distributed outside the United States to 14 countries. The source text does not specify which countries were affected or provide specific serial numbers for the 41 units in this particular recall notice, though a list of serial numbers is associated with the product code in the metadata. The firm states that no adverse health consequence is expected to occur from this labeling issue.
Healthcare providers and patients who have received these specific lead extensions should contact Boston Scientific Neuromodulation Corporation for further instructions on how to proceed. Because the issue is strictly related to the expiration date labeling and the firm anticipates no health impact, the recall is classified as a precautionary removal to ensure compliance with labeling regulations.
The recalled product
- Product
- Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the le
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 41
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 (20)
- Part number M365SC3138550
- serial numbers 1044463
- 1066242
- 3003060
- 1044464
- 1068589
- 3006620
- 1044466
- 1068602
- 3009041
- 1061554
- 1068606
- 3009045
- 1062766
- 1068608
- 3009050
- 1062770
- 1068611
- 3010114
- 1062787
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.
See all 7 products in this recall →Related recalls
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