Medtronic has issued an urgent Class I recall of certain spinal cord stimulator leads after reports of lead fractures that can cause unintended electrical stimulation or loss of pain relief therapy. The recall affects approximately 28,000 devices implanted in patients across the United States between January 2024 and February 2026.
The company says fracture analysis revealed a manufacturing defect in a specific lot of leads where the internal conductor wire is susceptible to fatigue failure at the point where the lead exits the spinal column. Patients with fractured leads may experience sudden jolts of electrical stimulation, loss of therapeutic effect, or in rare cases, localized tissue damage.
Medtronic is advising healthcare providers to contact affected patients for clinical evaluation and monitoring. The company says not all patients will require surgical lead replacement and that the decision should be made on a case-by-case basis. The FDA has classified this as the most serious recall category, indicating a reasonable probability that use of the product could cause serious health consequences.
