Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error
Boston Scientific is voluntarily removing certain spinal cord stimulation leads and extensions 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 from this labeling issue, which aligns with the rubric for Low severity (packaging-only problems or documentation issues).
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 LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700, which is part of a spinal cord stimulation system for prescription use only. These devices are used as an aid in the management of chronic intractable pain of the trunk and/or limbs. The specific unit identified has serial number 1042757.
The firm states that no adverse health consequence is expected to occur from this issue. The products were distributed outside the United States to 14 countries.
The recalled product
- Product
- The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits…
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 1
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 M365SC2352700
- serial number 1042757.
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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