Boston Scientific (NYSE:BSX) has initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system, according to a document filed by the Federal Institute for Drugs and Medical Devices in Germany.
The company said it was pulling these particular devices due to the number of complaints that it received relating to partial stent deployment.
When a stent isn’t fully released from its delivery system, it can become anchored in a vessel while the rest of the stent remains in the delivery system. Boston Scientific said the most commonly-reported injury caused by partial stent deployment has been vessel trauma and prolongation of the implant procedure, but that in some cases it has resulted in major surgery.
No other Eluvia or Innova stent system size was included in the voluntary removal, Boston Scientific pointed out, adding that the move doesn’t include previously-implanted devices.
The company asked that its customers immediately stop using any of the products listed in the voluntary recall document and that those particular stents be removed from customers’ inventories.