Boston Scientific Guiding Sheath Recall For Fracture
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
Pharmaceutical giant, Boston Scientific Corporation, recalled its global supply Chariot Guiding Sheaths which total 7,000. The recall was initiated because parts of the device can fracture during medical procedures. A guiding sheath is inserted into a patient's blood vessels so that other tools can slide through it and be easily directed to disease sites.
Boston Scientific recommended that doctors follow up with patients upon whom the sheaths were used for minimally invasive procedures in the legs and arms to assure they are not suffering from complications. The company has already received reports of device fracture and separation.
The Chariot Sheaths were only approved several months ago in June 2015. The recall was deemed class 1 by the FDA, the most serious recall possible. If the device fractures it could cause an embolism of device fragments that could lead to obstruction of blood flow. Obstruction of blood flow could result in stroke, kidney damage or damage to the intestines or limbs. It could also require re-intervention to remove any fragments.
If you were injured by a Boston Scientific product call the lawyers at Rheingold, Giuffra, Ruffo & Plotkin LLP, today at 800-349-0004. We have years of experience in medical device and pharmaceutical litigation and have already filed suit against Boston Scientific in other litigations.