Boston Scientific Recalls Spinal Cord Stimulation Extension Kits Due to Labeling Error
Boston Scientific is voluntarily removing 19 units of 35 cm 8 Contact Extension Kits because the 'use by date' on the label is later than the correct date.
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, and the issue is limited to 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 19 units of Thirty-five (35) cm 8 Contact Extension Kits, part number M365SC3138350. The recall is initiated because the 'use by date' displayed on the product label is later than the correct 'use by date'.
These contact extension kits are part of a spinal cord stimulation system intended for prescription use to manage chronic intractable pain. The affected units 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 labeling issue.
The recalled product
- Product
- Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact…
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Neuromodulation
- Hazard
- Affected units
- 19
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 M365SC3138350
- serial numbers 1041034
- 1055172
- 3000549
- 1041380
- 1056806
- 3000564
- 1053375
- 1058008
- 3001907
- 1053695
- 1058015
- 3007457
- 1053700
- 1058017
- 3008119
- 1054299
- 1062660
- 1054304
- and 1064590.
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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