FDA Identifies Boston Scientific Infinion CX Lead Recall as the Most Serious Type
Infinion CX Spinal Cord Stimulator Lead
Class I Recall for Boston Scientific Infinion CX Leads
The removal affects unused spinal cord stimulator leads. Previously implanted devices are not subject to the action, and no additional patient monitoring beyond routine follow-up is recommended.
The U.S. Food and Drug Administration has identified Boston Scientific’s removal of certain Infinion CX Leads as the most serious type of medical device recall because continued use of affected products may result in serious injury or death.
The action applies to unused Infinion CX Leads that remain at healthcare facilities or other locations where the products are used or distributed. It does not apply to leads that have already been implanted.
The Infinion CX Lead is a component of a spinal cord stimulation system used to help manage chronic pain.
Affected Products
The recall includes the following lead kits:
Infinion CX Lead Kit, 50 cm
-
- Model: SC-2317-50
- Material number: M365SC2317500
- GTIN: 08714729861614
Infinion CX Lead Kit, 70 cm
-
- Model: SC-2317-70
- Material number: M365SC2317700
- GTIN: 08714729861638
Reason for the Recall
According to Boston Scientific, the lead body may experience mechanical stress at the anchor site. This stress may result in lead fractures or abnormally high electrical impedance.
These conditions may interfere with stimulation and reduce the effectiveness of pain therapy. In some cases, additional medical intervention may be required, including removal and replacement of the lead.
As of May 27, 2026, Boston Scientific had reported 1,081 serious injuries and no deaths associated with the issue.
Actions for Healthcare Facilities
Boston Scientific sent an affected-customer letter on June 17, 2026, instructing customers to immediately stop using or distributing affected unused products, segregate the affected inventory, and return the products to Boston Scientific.
Customers should also share recall communications with healthcare professionals who use the products and notify other organizations to which affected products may have been transferred.
Boston Scientific stated that patients with previously implanted Infinion CX Leads do not require monitoring beyond routine clinical follow-up.
Regulatory and Quality Considerations
Healthcare facilities and distributors should confirm that affected inventory has been identified, segregated, and returned. Organizations should also document their response to the recall, notify all applicable internal and external recipients, and verify that affected units have not remained available for use.
Because the action does not include implanted devices, communications should clearly distinguish between unused affected inventory and leads already in patients. This distinction can help prevent unnecessary patient concern while ensuring that unused devices are promptly removed from circulation.
U.S. customers with adverse-event reports, product-quality concerns, or questions may contact Boston Scientific at BSCComplaints@bsci.com. Healthcare professionals and consumers may also report device-related problems through the FDA’s MedWatch program.
Additional information, including affected-device identifiers, is available in the FDA recall notice.
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