This recall involves removing unused devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
Figure 1. Infinion CX Lead
The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all unused Infinion CX Leads be removed from where they are used or sold. This action does not affect the devices that have already been implanted.
Affected Devices:
Device Name | Model | Material | GTIN |
|---|---|---|---|
Infinion CX Lead Kit, 50 cm | SC-2317-50 | ||
Infinion CX Lead Kit, 70 cm | SC-2317-70 |
What to Do
Immediately stop use and distribution of affected products.
On June 17, 2026, Boston Scientific sent all affected customers a letter recommending the following actions:
- Immediately stop further use or distribution and segregate affected product.
- Return product to Boston Scientific.
- Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which these systems may have been transferred.
- No additional patient monitoring beyond routine clinical follow-up is recommended.
Reason for Recall
Boston Scientific stated that the Spinal Cord Stimulator (SCS) System lead body may experience mechanical stress at the anchor site, which may result in high impedance measurements or lead fractures. Abnormal impedance measurement may lead to inadequate stimulation and/or additional intervention, including lead explant and replacement.
As of May 27, 2026, Boston Scientific has reported 1,081 serious injuries and no deaths associated with this issue.
Device Use
The Infinion CX Lead is a component of a Spinal Cord Stimulator System which is used in the management of chronic pain of the back of limbs.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCComplaints@bsci.com.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.