A recalled item was Boston Scientific Corporation’s Chariot Guiding Sheath. Almost 6000 of these devices were recalled. The Guiding Sheath is used to help guide placement of interventional devices into peripheral vasculature. The reason for the recall was that fourteen complaints were filed where the shaft of the device separated from the guide. This can result in small pieces becoming dislodged and enter the patient’s bloodstream. This will result in serious organ damage and potentially death. The FDA is partially responsible for this issue. The FDA already has strict rules in place for medical devices but sometimes certain issues or problems are not faced during the clinical studies. Again, the percentage of defects was low compared to 6000 devices sold but human lives were still at risk. Therefore, the FDA does deserve some blame. However, majority of it falls on the Company itself because it is their product and they are thus responsible.

http://wayback.archive-it.org/7993/20170112083736/http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm478913.htm