Teleflex Medical has recalled 62,882 units of its Hudson RCI Sher-I-Bronch endobronchial tube because the double swivel connector may break or separate on the tube while it is inserted into a patient’s airways. The recall — involving 12 product codes — covers devices manufactured from October 2013 to April 2015 and distributed through May of this year. Earlier this summer, the recall of Hudson RCI Lifesaver single-patient use resuscitator was announced after reports of oxygen intake ports becoming blocked, preventing the delivery of breathing support.
EU OKs St. Jude Pain System Labeling
St. Jude Medical has received CE Mark approval for MRI conditional labeling of its Prodigy MRI chronic pain system with select leads. The launch will ensure patient access to the company’s proprietary burst stimulation and traditional tonic stimulation. The Prodigy MRI system will become the market’s smallest MR-conditional rechargeable implantable pulse generator, according to the company. Octrode percutaneous and Penta 5-column paddle leads have received MR-conditional labeling and are approved for use with Prodigy MRI.
Medtronic to Buy Twelve for $458M
Medtronic has reached an agreement to buy a company focused on transcatheter mitral valve replacement. The device giant will buy Redwood City, Calif.-based Twelve for $458 million — $408 million upfront, and the remaining $50 million after a TMVR device in development gains CE mark approval. Twelve is the 12th company spun out from the medical device incubator The Foundry. “We have followed the transcatheter mitral valve space closely and firmly believe that Twelve has the most novel technology along with a strong, proven team,” says Sean Salmon, senior vice president and president, Coronary & Structural Heart, Medtronic, in a prepared statement.
Greatbatch to Buy Lake Region Medical
Frisco, Texas-based Greatbatch has offered to buy Lake Region Medical, formerly Accellent, for about $1.7 billion in cash and stock. The proposed combination would result in one of the largest medical device original equipment manufacturer suppliers in the world, serving the cardiac, neuromodulation, vascular, orthopedics and advanced surgical markets, according to a Greatbatch statement. Wilmington, Mass.-based Lake Region’s portfolio includes electrophysiology, oncology, laparoscopy and arthroscopic products.
BD Unit Buys Cellular Research
Becton, Dickinson’s life sciences unit has scooped up Menlo Park, Calif.-based Cellular Research for an undisclosed amount. The two companies already have partnered to develop single cell analysis workflows for Cellular Research’s Precise product line and BD’s FACS instruments and software. “The addition of Cellular Research builds on our GenCell acquisition and underscores BD’s commitment to a genomics strategy focused on next generation sequencing (NGS) sample preparation,” says Linda Tharby, executive vice president and president of BD Life Sciences, in a prepared statement.