Boston Scientific INFINION CX Lead Kits Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific Neuromodulation Corporation is recalling 1,079 INFINION CX Lead Kits due to potential lead body stress that may cause fractures or high impedance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references New York, United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
What Happened
The spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
Which Products Are Affected
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. Part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems. Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products. 1,079 units affected. Distributed in US: NY and OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina. Recall number Z-2879-2026. Class I recall initiated June 17, 2026.
What You Should Do
Contact the recalling firm Boston Scientific Neuromodulation Corporation for further information regarding the recall.
Why This Matters
The recall involves a Class I device where use may cause serious adverse health consequences.
Source
FDA recall number Z-2879-2026, Boston Scientific Neuromodulation Corporation, Valencia, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,278 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.