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Boston Scientific recalls spinal cord stimulator leads after more than 1,000 serious injuries

Boston Scientific recalls spinal cord stimulator leads after more than 1,000 serious injuries

Rule Changes

FDA Class I recall covers unused Infinion CX leads; implanted devices remain in place

4 days ago: Fierce Biotech reports on recall and injury count

Overview

Updated 4 days ago

Boston Scientific pulled unused spinal cord stimulator leads from the market after the FDA linked them to more than 1,000 serious injuries. The Infinion CX lead, which delivers electrical pulses to mask chronic pain, can fracture where it anchors to the spine.

The recall covers only unused inventory, not devices already implanted in patients. But the 1% fracture rate over a decade of implants raises questions about the lead's design. The replacement, the Infinion Pro, uses a changed lead body configuration that may or may not fix the problem.

Why it matters

Patients with implanted Infinion CX leads may face inadequate pain relief or revision surgery if the lead fractures at the anchor site.

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Key Indicators

1,081
Serious injuries reported
As of May 27, 2026, per Boston Scientific's report to the FDA.
1,079
Unused leads recalled
Devices subject to the Class I recall, per the FDA recall database.
1%
Lead fracture rate
Between September 2014 and April 2026, per Boston Scientific's field safety notice.
Class I
FDA recall classification
Most serious recall category; continued use may cause serious injury or death.

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Organizations Involved

Boston Scientific
Boston Scientific
Medical device manufacturer
Recalling unused Infinion CX leads; transitioning to Infinion Pro

Medical device maker that recalled its Infinion CX spinal cord stimulator leads after FDA linked them to more than 1,000 serious injuries.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulatory agency
Classified Infinion CX lead recall as Class I

Federal agency that regulates medical devices and classified the Infinion CX lead removal as its most serious recall category.

Timeline

September 2014 September 2026

6 events Latest: 4 days ago
Tap a bar to jump to that date

  1. Fierce Biotech reports on recall and injury count

    Latest Media

    Fierce Biotech covers the recall, noting more than 1,000 serious injuries tied to the leads.

  2. FDA classifies recall as Class I

    Regulatory

    FDA assigns most serious recall category, covering about 1,079 unused leads.

  3. Boston Scientific initiates recall

    Recall

    Company sends letters to customers to stop use and return unused Infinion CX leads.

  4. Boston Scientific reports 1,081 serious injuries

    Reporting

    Company reports serious injuries tied to Infinion CX lead fractures to the FDA.

  5. Fracture data collection period ends

    Data

    Boston Scientific records a 1% fracture rate for Infinion CX leads over the collection period.

  6. Infinion CX lead enters market

    Product Launch

    Boston Scientific begins selling the Infinion CX lead for chronic pain management.

Scenarios

1

Boston Scientific completes Infinion CX lead removal

Likely Resolves by Jun 17, 2027

Discussed by: FDA recall database tracking

The company returns all unused leads to Boston Scientific, and the FDA closes the recall. The transition to Infinion Pro continues as planned. The recall remains open until all affected product is removed from distribution channels.

2

Patient lawsuits over Infinion CX leads consolidate into MDL

Possible Resolves by Sep 8, 2027

Discussed by: Legal analysts tracking spinal cord stimulator litigation

Plaintiffs file suits alleging the lead defect caused revision surgeries. The Judicial Panel on Multidistrict Litigation may consolidate cases, similar to the existing WaveWriter spinal cord stimulator MDL in the Central District of California.

3

Infinion Pro replacement lead shows lower fracture rate

Uncertain Resolves by Jun 17, 2028

Discussed by: Boston Scientific, clinical data

Post-market data on the Infinion Pro demonstrates the design change resolves the anchor-site stress issue. The company publishes updated fracture rates showing improvement over the Infinion CX's 1% failure rate.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

October 2007

Medtronic Sprint Fidelis recall (2007)

Medtronic recalled its Sprint Fidelis defibrillator leads after they were found to fracture, potentially causing inappropriate shocks or failure to deliver life-saving therapy. The leads were implanted in about 268,000 patients worldwide.

Then

Class I recall, FDA investigation, Medtronic stopped selling the leads immediately.

Now

Thousands of lawsuits, Medtronic paid over $200 million in settlements, and the recall became a case study in implantable device failures.

Why this matters now

Like the Infinion CX, the Sprint Fidelis was a lead that fractured in the body, requiring surgical intervention. The recall pattern, including Class I classification and litigation, is nearly identical.

August 2010

DePuy ASR hip recall (2010)

Johnson & Johnson's DePuy Orthopaedics recalled its ASR hip replacement systems after data showed high failure rates within five years of implantation. About 93,000 patients were affected worldwide.

Then

DePuy offered to cover revision surgery costs and faced immediate litigation.

Now

Johnson & Johnson paid roughly $2.5 billion to settle U.S. patient claims, one of the largest medical device settlements in history.

Why this matters now

Shows the scale of litigation and financial exposure that can follow a large implant recall, a trajectory the Infinion CX cases may follow.

Sources

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U.S. Food and Drug Administration MedTech Dive Medical Daily RecallWatch Fierce Biotech AboutLawsuits.com Legal Examiner