
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
U.S. health officials have issued warnings on two separate Boston Scientific heart devices recently linked to injuries and deaths. The agency said Wednesday an issue with defibrillator wires could cause the implants to fail to deliver adequate electrical shocks. The company warned doctors about the issue last month. Separately, the FDA flagged updated instructions for the company’s Watchman heart implant, which is used to reduce the risk of stroke. Boston Scientific said it has seen an increased risk of dangerous blockages in the bloodstream depending on how the device is implanted. The company says the problem is not related to the device design.