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Four patients died after switching to a new form of controller for Thoratec’s HeartMate II Left Ventricular Assist System, the company revealed in a Tuesday recall announcement, adding the deaths did not involve a product malfunction. Read More
Devicemakers importing goods for sale in Europe will need to comply with a revised hazardous substances directive if they are deemed “free for circulation on the EU market,” an industry guidance says. Read More
India’s Ministry of Health and Family Welfare has begun publishing data about compensation paid in clinical trial-related deaths, with the first wave of data covering 2010 into 2013. Read More
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More
St. Jude’s Sylmar, Calif., plant, which makes most of its CRM products, should soon emerge from an FDA warning letter, CEO Dan Starks said on the company’s earnings call last month. Read More
The reorganization of CDRH’s Office of Compliance and creation of a Division of Manufacturing Quality has provided a shot in the arm to the center’s Case for Quality Initiative — fueling two pilot programs designed to increase inspection efficiencies without sacrificing quality, OC Director Steve Silverman says. Read More
The FDA is asking healthcare providers to report adverse events related to Teleflex Medical’s ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. Read More
Maquet Cardiovascular received a Form 483 with 17 observations, including several repeat observations related to complaint reporting, process validation, CAPAs and other issues. Read More
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