The company said the lead body could experience mechanical stress at the anchor site, which could cause the abnormal impedance measurements or fractures.
High impedance measurements could lead to inadequate stimulation and/or additional surgical intervention, such as lead explant and replacement, according to the FDA recall.
The FDA classified the recall as Class I, the most serious type, in which use of the device without correction may cause serious injury or death. As of May 27, 2026, Boston Scientific has reported 1,081 serious injuries associated with the issue.
The medical device manufacturer issued a letter in June advising customers to immediately halt further use and stop distribution of the affected Infinion CX leads and isolate the products.
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The recall does not affect devices already implanted in patients, the FDA said, only unused inventory. The company said no additional patient monitoring beyond a routine clinical follow-up was recommended.
Device manufacturers have recently faced mounting litigation involving spinal cord stimulation devices.
Several lawsuits were filed by patients who have allegedly suffered injuries after implanted Boston Scientific SCSs allegedly malfunctioned or failed. In June 2026, the U.S. Judicial Panel on Multidistrict Litigation determined that all claims against the company will be centralized into a single case.
MassDevice contacted Boston Scientific for comment and did not receive a response at the time of publication. We will update this story as necessary.
