MASSDEVICE ON CALL — A bellwether trial against Johnson & Johnson (NYSE:JNJ) began this month with lawyers beginning to select jurors to hear a lawsuit accusing the healthcare giant of liability patient injuries allegedly caused by the company’s transvaginal mesh implants.
Recalls
St. Jude defends Durata amid FDA warning at manufacturing facility
St. Jude Medical‘s (NYSE:STJ) implanted cardiac device market share is in great shape despite ongoing issues with its high-voltage defibrillator leads, CEO Daniel Starks told an audience at the J.P. Morgan healthcare conference last night.
Can Boston Scientific capitalize on St. Jude’s challenges?
Boston Scientific (NYSE:BSX) is looking for ways to leverage its product pipeline in 2013, part of which may include capitalizing on some of the "challenges" facing one of their biggest rivals.
Praxair recall gets Class I status from FDA
Praxair’s Grab ‘n Go Vantage Portable Oxygen Cylinder, a device designed to convert a high variable medical gas pressure to a lower and constant working pressure, has received Class I status from FDA.
Last November, the company recalled the Grab ‘n Go Vantage Portable Oxygen Cylinder over concerns that the cylinder unit of device may break and release the oxygen, causing serious adverse health consequences or death, the watchdog agency noted.
Medical device recalls for December 2012
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Legal fights over recalled hips and transvaginal mesh begin this year | MassDevice.com On Call
MASSDEVICE ON CALL — This year promises to be a big one for medical device legal battles, as bellwether trials for several high-profile device disputes are slated for later in 2013.
Zimmer recall gets FDA’s highest-risk Class I status | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA slapped medical device giant Zimmer Holdings (NYSE:ZMH) with Class I status for a global recall of the company’s PEEK Ardis Inserter instruments over concerns that the devices could cause issues during surgery.
Abbott prepares to split | MassDevice.com On Call
Bunnell recalls ventilator circuits over melting risk
Salt Lake City, Utah-based medical maker Bunnell Inc. this month launched a nationwide recall of its Life Pulse High-Frequency Ventilator Patient Circuits after receiving failure reports among certain lots.
Bunnell received reports of failure for 12 out of 5,743 circuits, which are used for ventilating critically ill infants with pulmonary interstitial emphysema and those with respiratory distress syndrome.
The circuits provides a conduit for the humidification, warming, and temperature monitoring of the pressurized gas, according to an FDA notice.
Medtronic recall gets Class I status from FDA | MassDevice.com On Call
MASSDEVICE ON CALL — The FDA slapped Medtronic’s (NYSE:MDT) recall with Class I status over concerns that the medical device maker’s SynchroMed II infusion pumps may fail in certain circumstances.
Medtronic initiated a recall on the devices in November after finding higher-than-expected rates of failure when the implantable SynchroMed II pumps were used with "unapproved drugs."
Zimmer Spine launches urgent global recall
Medical device giant Zimmer Holdings (NYSE:ZMH) launched an urgent worldwide recall of its PEEK Ardis Inserter instruments after receiving reports that they may fracture Ardis Interbody Spacers during spinal surgery.
There are about 315 units to recall, according to a press release, and no adverse events associated with the fractured devices have yet been reported.