Medtronic's Covidien was hit with a recall of 1,661 units of its VenaSeal Sapheon Closure System, a procedural delivery system for an adhesive that treats venous reflux disease by closing the affected veins in the lower leg.
The FDA halted the manufacture of Medtronic's SynchroMed II Implantable Infusion Pump Systems, citing repeatedly failing to correct violations of the agency's quality system regulations in a consent decree filed against company CEO Omar Ishrak and Senior Vice President Thomas Tefft.
On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of its facilities, the suspension of 5 of Germany's Maquet Holding's devices from the market and a $6 million fine, the FDA announced the recall of all 4,154 units of its stroke-fighting TigerPaw System II left atrial appendage closure device.
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.