Boston Scientific Recalls Spinal Cord Stimulation Adapters Due to Labeling Error
Boston Scientific is voluntarily removing two Precision M8 Adapters 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, and the issue is a documentation/labeling error, which aligns with the 'Low' severity criteria for packaging or documentation issues.
Plain-English summary
Boston Scientific Neuromodulation Corporation is voluntarily removing two units of the Precision TM M8 Adapter, 15 cm (part number M365SC9218150). These adapters are part of a spinal cord stimulation system used to manage chronic intractable pain. The recall is due to a labeling error where the 'use by date' displayed on the product is later than the correct date.
The affected units have serial numbers 1043743 and 1051329. The products were distributed only outside the United States to 14 countries. The source text states that no adverse health consequence is expected to occur from this issue.
Consumers and healthcare providers who have these specific units should contact Boston Scientific Neuromodulation Corporation for further instructions on the voluntary removal.
The recalled product
- Product
- Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or…
- 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 M365SC9218150
- serial numbers 1043743 and 1051329.
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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