There were 426 medical device recalls in the first quarter of this year, according to FDA's recall database, down from a record high of 968 in Q4 2014.
Boston Scientific is initiating a recall of some of its biliary drainage catheters after 11 reports of device fragmentation, according to the FDA's recall database. The recall is labeled Class II, meaning the device "may cause temporary or medically reversible adverse health consequences."
The European Commission is concerned that the $13.4 billion acquisition of Biomet by Zimmer will result in price increases due to reduced competition in orthopedic implants in the European Economic Area. In order to allay these fears, Zimmer has agreed to divest three businesses in specific European markets.
Baxter International is working to scale up its dialysis product manufacturing because it's been unable to meet demand. In September 2013, Baxter acquired Gambro for $4 billion, which is slated to be part of the core of the new medical products focus for Baxter, while a new company, Baxalta, will hold all the biopharma assets of the current company.
Zimmer is in the midst of a recall of a component of its latest total knee replacement system, Persona. The orthopedic company notified customers in mid-February and FDA has now classified the action as a Class 2 recall.
Johnson & Johnson's DePuy Synthes issued a recall last month for 1,500 inserters of titanium elastic nails distributed in the U.S., which the FDA has just disclosed. The warning was given because the inserter is prone to mechanical failure during surgery such as breakage in the main shaft, a jam in the inserter or breakage of the crossbar.
The FDA has issued a Class 2 recall notice for an electrophysiology cardiac catheter from Biosense Webster, which is a Johnson & Johnson company, due to difficulties with retraction. The recall covers the Lasso NAV Duo Loop eco Catheters. Biosense Webster is the top-performing J&J medical device group as electrophysiology has gained traction of late.
The FDA issued a pair of Class II recall notices on Feb. 24 for the EndoWrist One Vessel Sealer. The agency said the device may "exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws."
AliveCor has recalled the Alive ECG App 2.1.2 for its mobile phone-enabled AliveCor Heart Monitor electrocardiogram.
The FDA announced a massive, worldwide recall of nearly 16 million of Teleflex Medical's Aquapak humidifiers due to a faulty accessory that may contain foreign materials that look like black particles.