Boston Scientific has issued another recall, this time for its spinal cord implant used to treat pain.
The FDA said in an early alert recently posted to the U.S. regulator’s website that the device maker issued a recall on June 17 for all unused Infinion CX Leads due to the possibility they may break.
The regulatory agency calls a recall only in the most serious cases, which means the product may cause serious injury or death if used.
As of May 27, Boston Scientific reported 1,081 serious injuries related to the device and no deaths. The recall does not affect devices that have already been implanted, the company said.
The Infinite CX Lead is part of a spinal cord stimulator that delivers mild electrical pulses to the spinal cord system to block pain signals to the brain for patients suffering from chronic pain in the back and limbs.
The recall covers models SC-2317-50 and SC-2317-70 that come in 50cm and 70cm lengths, respectively.
The company has been going through a rough patch as of late. A week ago, the FDA posted an early alert that Boston Scientific issued a letter Aug. 24 that its Imager II angiographic catheters be removed from shelves due to a manufacturing issue with the tips of the devices.
The catheters, the medtech said, were manufactured with “reduced levels of stabilizing agents in the tips that risked tip degradation and detachment. As of July 16, two serious injuries and no deaths were associated with that recall.
In late August, the company suffered a serious cyberattack that impacted its global operations and production base.
Boston Scientific said earlier this year that it initiated a restructuring plan that would likely result in layoffs as it trimmed its top guidance estimates by 2% due to challenges to sales.