Infinion CX recall: what Boston Scientific SCS patients should check
Last reviewed: September 30, 2026
If a Boston Scientific spinal cord stimulator has already put you through
shocks, burning, loss of stimulation, a revision surgery, or an explant, a
recall notice can sound bigger than it is. This one is important, but it
needs a careful read.
The FDA has classified Boston Scientific's removal of unused Infinion CX
spinal cord stimulator leads as a Class I recall. That is FDA's most
serious recall category. The recall covers unused Infinion CX Lead Kits in
50 cm and 70 cm lengths, model numbers SC-2317-50 and SC-2317-70.
Here is the narrow point: FDA says Boston Scientific told customers to
stop using and distributing affected unused leads, set them aside, return
them, and share the notice with health care professionals who use the
product. FDA also says the action does not affect devices that have
already been implanted.
The concern is mechanical stress at the anchor site. FDA says that stress
may cause high impedance readings or lead fractures. In plain English, the
lead may not be delivering stimulation the way it should. FDA says
abnormal impedance may lead to inadequate stimulation and additional
intervention, including lead explant and replacement.
The number families will notice is 1,081. FDA says that, as of May 27,
2026, Boston Scientific had reported 1,081 serious injuries and no deaths
associated with the issue. The same FDA notice says no extra patient
monitoring beyond routine clinical follow-up is recommended.
So no, the notice is not a reason to stop therapy on your own or demand
removal without a doctor. Device decisions are medical decisions first.
But if your records mention Infinion CX, high impedance, lead fracture,
loss of stimulation, revision surgery, or explant, the recall gives you a
concrete item to flag during a legal review.
Why this recall matters in MDL 3181
The federal Boston Scientific spinal cord stimulator cases are centralized
in MDL 3181 before Judge Josephine L. Staton in the Central District of
California. The Judicial Panel on Multidistrict Litigation created the MDL
on June 5, 2026.
The panel did not create one giant spinal cord stimulator MDL for every
manufacturer. It limited MDL 3181 to Boston Scientific cases. That line
still matters for patients trying to figure out whether their device
history fits this docket or belongs on a different path.
The JPML transfer order described allegations involving poor pain relief,
shocking, burning, lead migration, autonomic dysfunction, and neurological
injuries after implantation. The Infinion CX recall does not prove those
allegations. It is a regulatory event, not a court ruling. Still, it
touches a problem families recognize: a lead issue, a loss or change in
stimulation, and sometimes another procedure.
Judge Staton's court has also entered a direct-filing order for MDL 3181.
In everyday terms, certain new cases that would otherwise be transferred
into the MDL may be filed directly in the Central District of California
for coordinated pretrial proceedings. That can save procedural time, but
it also means the basic paperwork needs to be gathered early.
For the broader case background, start with our Boston Scientific spinal
cord stimulator lawsuit hub:
https://masstortamerica.com/mass-torts/spinal-cord-stimulator/
For the court procedure piece, see our article on the MDL direct-filing
order and the records we would gather first:
https://masstortamerica.com/mass-torts/boston-scientific-scs-mdl-direct-filing-records/
For a separate example of an FDA adverse-event paper trail involving
shocks, burning, lead movement, and explant, see:
https://masstortamerica.com/mass-torts/boston-scientific-wavewriter-alpha-maude-report-explant/
What to pull from your records
You do not have to prove the whole case in one weekend. The first job is
simpler: identify the device, show what changed, and show what doctors did
next.
Useful records may include:
- the implant card or device identification card;
- the operative report from the original implant;
- device stickers or model numbers for the generator and leads;
- programming notes showing high impedance, loss of coverage, or repeated reprogramming;
- imaging reports that mention lead fracture, lead migration, or lead movement;
- pain-clinic notes describing shocks, burning, loss of stimulation, or worsening symptoms;
- revision, lead replacement, or explant records; and
- portal messages or phone notes that show when symptoms were first reported.
If your implant card lists SC-2317-50, SC-2317-70, Infinion CX, or another
Boston Scientific lead, keep a copy. If you cannot find the card, ask the
implanting hospital or surgery center for the operative report and the
scanned device stickers. Those stickers are often tucked into the surgical
record.
What the recall does not prove
This recall does not say every Infinion CX lead will fracture. It does not
say every Boston Scientific stimulator patient has a lawsuit. It does not
establish that Boston Scientific is liable in MDL 3181. And it should not
be treated as medical advice.
What it does provide is a specific checkpoint. If the device stopped
working, caused painful stimulation, required repeated troubleshooting, or
led to revision or explant surgery, the lead model and impedance history
may be important.
FAQ
Does the Infinion CX recall apply to implanted devices?
FDA says Boston Scientific's removal action covers unused Infinion CX
leads and does not affect devices that have already been implanted. FDA
also says no additional patient monitoring beyond routine clinical
follow-up is recommended.
What injuries did FDA report?
FDA states that Boston Scientific reported 1,081 serious injuries and no
deaths associated with the Infinion CX issue as of May 27, 2026. The
reported problem involves mechanical stress at the anchor site that may
cause high impedance or lead fractures.
Does high impedance matter for a legal review?
It can. FDA says abnormal impedance may lead to inadequate stimulation and
additional intervention, including lead explant and replacement. A review
usually looks for records that connect the device identity, symptoms,
troubleshooting, and any revision or removal procedure.
Sources
- FDA, Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/spinal-cord-stimulator-recall-boston-scientific-removes-infinion-cx-lead
- FDA recall database, Class I Device Recall Infinion CX Leads, Recall Z-2879-2026: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=220311
- U.S. Judicial Panel on Multidistrict Litigation, MDL 3181 Transfer Order: https://www.jpml.uscourts.gov/sites/jpml/files/MDL-3181-Transfer_Order-5-26.pdf
- U.S. District Court for the Central District of California, MDL 3181 Pretrial Order No. 4 Direct Filing Order: https://www.cacd.uscourts.gov/sites/default/files/documents/58_Pretrial-Order-No.-4.pdf
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Robert B. Baker, Esq., B.C.S. — Board-Certified Civil Trial Lawyer. 30+ years of trial experience, more than $400 million recovered for clients. About Robert Baker →