FDA-Device2020-06-03Class II
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 extension kits are 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. They are designed to connect the percutaneous leads
Hazard
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Sold states
Distributed OUS only. to 14 countries.
Affected count
19 units
Manufactured in
25155 Rye Canyon Loop, N/A, Valencia, CA, United States
Products
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 extension kits are 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. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2120-2020More Boston Scientific Neuromodulation Corporation recalls
- FDA-Device2026-06-17Boston Scientific CSK Electrodes recalled for substandard performance
- FDA-Device2026-06-17Boston Scientific Clik X Anchor recalled for sterility assurance concerns
- FDA-Device2026-06-17Boston Scientific TCN Electrodes recalled for substandard performance
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief