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.
Recalls
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.
Recalls: Haemonetics warns on potential leaks
St. Jude shareholders accuse leadership of hiding Durata flaws
Updated Dec. 13, 2012, at 3:30 p.m. with comment from St. Jude Medical.
A group of St. Jude Medical (NYSE:STJ) shareholders filed a lawsuit accusing the company and 3 executives of making "false and misleading statements" about the Durata heart implant wires.
DePuy aims to dismiss patient lawsuit against recalled hip implant
Verathon recalls reusable laryngoscope blades over potential breakage
Medical device maker Verathon Inc. recalled certain lots of its reusable laryngoscope blades after finding that they may be prone to cracks and breaks that may leave pieces in a patients mouth where they may be swallowed or block the airway.
The blades in question belong to the company’s GlideScope GVL video laryngoscopes, designed to provide a "consistently clear, real-time view of the patient’s airway, enabling quick intubation," according to the company’s website.
Medical device recalls for November 2012
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall