Boston Scientific Corp. Halts Sale Of ICDs (BSX)
Boston Scientific Corp. (NYSE: BSX) has stopped the shipment of its implantable cardioverter defibrillators. The company is also in the process of retrieving inventory of its ICDs. The medical device manufacturer said it “has determined that some manufacturing process changes were not submitted for approval to the Food and Drug Administration. At this time, the company has identified two instances of changes that, while successfully validated, were not submitted to the FDA. Boston Scientific has informed the FDA and plans to work closely with the agency to resolve this situation as soon as possible."
However, Boston Scientific Corp. (BSX) has said that there is no indication that the process changes have created any risk to patients’ safety. The company is “indefinitely suspending” sales of the device.
