A lead placed in the body can break where it was anchored — 13 device records concern an implant (Boston Scientific)
The U.S. Food and Drug Administration classified Boston Scientific's INFINION CX lead kits (50 cm and 70 cm) for its Spinal Cord Stimulator systems as Class I — its most serious category. The lead body may be exposed to stress at the anchor site, which can produce high impedance readings or lead fractures. That can leave stimulation inadequate and require further intervention, including explanting and replacing the lead. The quantity is 1,079 units.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmBoston Scientific Neuromodulation Corporation
- ReasonSpinal 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.
- DistributionUS: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina
- Recall initiated2026-06-17
Key points
- Recall number Z-2879-2026; FDA Class I, the most serious category; status Ongoing.
- The products are Boston Scientific INFINION CX lead kits, 50 cm (SC-2317-50) and 70 cm (SC-2317-70), for Spinal Cord Stimulator systems.
- The reason is that the lead body may be exposed to stress at the anchor site, producing high impedance measurements or lead fractures.
- This may leave stimulation inadequate and require additional intervention, including explanting and replacing the lead.
- Quantity 1,079 units. New York only within the U.S.; 18 countries abroad across Canada, Europe, the Middle East, and South America. Initiated 2026-06-17.
- Of the 779 device records this site holds as of 2026-09-01, 13 mention an implant in the reason.
1Spinal cord stimulation and what the lead does
Spinal cord stimulation treats chronic pain by placing a thin electrode — the lead — near the spinal cord in the epidural space and delivering mild electrical pulses that change how pain signals travel. A pulse generator is implanted in the body, and the lead connects it to the spinal side. The lead is therefore the single path through which the entire effect of the therapy passes.
Once placed, the lead is fixed with a component called an anchor so that body movement does not shift it. Migration would move the point being stimulated and reduce the benefit, so anchoring is necessary. But fixing something also means creating one point that cannot move.
2A structural weakness at the point that is held still
The stated reason for this recall is exactly that: the lead body may be exposed to stress at the anchor site. The body bends and straightens all day, and at a single fixed point that force cannot be dissipated, so load concentrates there repeatedly. The record says this may result in high impedance measurements or in lead fractures.
A rise in impedance is the standard electrical signal that a conductor is failing or has failed.
What matters is what comes next. Beyond "inadequate stimulation," the record explicitly says additional intervention may be required, including explanting and replacing the lead. A fault in an implanted device is not a matter of swapping a part; it leads to a decision about whether to undergo surgery again.
3New York only in the U.S., 18 countries abroad
The distribution record is distinctive. Inside the United States it is New York alone, while outside it spans 18 countries across Canada, Europe, the Middle East, and South America. Against a quantity of 1,079 units, the geographic spread is the larger figure.
For an implanted device, the only party that can identify the affected patients is the center that performed the implant, so the effectiveness of the recall depends on reaching clinicians in each country.
4Thirteen device records concern an implant
Of the 779 device records this site holds as of 2026-09-01, 13 mention an implant in the reason for recall.
A device placed inside the body cannot be dealt with by taking it back. Removing it is itself surgery, which is why a record like this one speaks of explantation and revision. The weight of a device recall is set not only by the size of the fault but by what correcting it costs.
Why it matters
A recall of an implantable device is not completed by withdrawing stock; the substance of it is the response for patients who already have the device. Only the implanting center knows who those patients are, so effectiveness depends on the quality of the communication path from the manufacturer to clinicians in each country. With a distribution like this one — a single U.S. state but 18 countries abroad — the speed of information moving through national regulators and distributors is what separates a good response from a slow one.
FAQ
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Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2879-2026