Philips subsidiary Spectranetics recalls Bridge occlusion balloon
Royal Philips (NYSE:PHG) subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens.
The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was prompted by nine reports of blocked guidewire lumens, although no deaths or serious injuries were reported.
“Based on inspection, the frequency of a potentially blocked guidewire lumen is estimated to be approximately 10%,” the company said…..
