Dive Brief:
- Boston Scientific is recalling Infinion CX leads used with its spinal cord stimulator systems due to risk of fracture or need for lead replacement, the Food and Drug Administration said Thursday in a recall notice. The action applies to unused Infinion CX leads.
- As of May 27, the company has reported 1,081 serious injuries associated with an issue where the lead body may experience mechanical stress at the anchor site, according to the notice.
- In a statement emailed to MedTech Dive, Boston Scientific noted that an event can be categorized as a serious injury under FDA reporting requirements when medical or surgical intervention is required. In its notice, the FDA said the recall does not affect devices already implanted in patients, and no additional patient monitoring beyond routine clinical follow-up was recommended.
Dive Insight:
The lead is a component in spinal cord stimulation systems used to manage chronic pain. Leads deliver electrical pulses from an implantable pulse generator to the spinal cord to mask pain signals to the brain.
In the Class I recall notice, the FDA said the stress to the Infinion CX lead may result in high impedance measurements or lead fractures. These in turn could cause inadequate stimulation and lead to removal and replacement of the implant.
“The most frequently observed harm is inadequate stimulation,” Boston Scientific said in its statement. “If reprogramming does not resolve the issue, additional intervention, including lead explant or replacement, may be required. These interventions represent the most serious harm observed.”
Boston Scientific instructed customers in a June 17 letter to stop use and distribution of the leads and return unused devices to the company. The FDA’s Aug. 5 recall database entry said the removal of unused Infinion CX leads is part of a planned transition to the next generation Infinion Pro lead. The recall affects 1,079 devices, according to the FDA database.
“Infinion CX leads were already being phased out, and Boston Scientific has ended manufacturing of the product,” the company said in its email, adding that the newer Infinion Pro leads have replaced Infinion CX leads for new implants and lead replacements.
“For patients with implanted Infinion CX leads, the issue may present as high impedance, inadequate stimulation or loss of stimulation and can be evaluated through routine follow-up and standard device troubleshooting, including reprogramming when appropriate,” the company wrote. “If the issue cannot be resolved, the affected lead can typically be removed and replaced while the implanted stimulator remains in place.”
In a separate recall last month, Boston Scientific told customers to stop using or distributing Imager II angiographic catheters due to an issue that can increase the risk of the tip detaching. That recall was associated with two serious injuries. The company is discontinuing the product.
