Boston Scientific Recalls Deep Brain Stimulation Lead Extensions Due to Labeling Error
Boston Scientific is voluntarily removing specific Deep Brain Stimulation lead extensions because the 'use by date' on the label is later than the correct date.
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 recall is for a labeling error (incorrect 'use by date') and the source explicitly states that no adverse health consequence is expected, fitting the criteria for a Low severity recall.
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 specific product identified in this recall is the Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550. The recall involves 8 units with specific serial numbers: 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225, and 3012324.
The reason for this recall is that the 'use by date' displayed on the product label is later than the correct 'use by date'. This is a labeling error regarding the expiration date of the medical device.
The products were distributed outside the United States to 14 countries. The source text explicitly states that no adverse health consequence is expected to occur from this issue. Users of these devices should contact Boston Scientific Neuromodulation Corporation for further instructions regarding the removal of the affected units.
The recalled product
- Product
- Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 8
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 (8)
- Part number M365NM3138550
- serial numbers 1049357
- 1057232
- 3014616
- 1053194
- 3010769
- 3014631
- 1057225 and 3012324.
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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