Category: Cook Medical
Manufacturers of inferior vena cava filters and 2 medical societies team up for a large-scale study of the pulmonary embolism preventers, 4 years after an FDA warning about the devices.
The Society of Interventional Radiology, the Society for Vascular Surgery and 7 medical device companies are teaming up for the 1st large-scale study of inferior vena cava filters, 4 years after an FDA warning that the devices might dislodge or fracture.
Cook Medical releases 2 favorable studies supporting the use of its Zilver PTX stent in the treatment of peripheral artery disease, or PAD.
Cook Medical released 2 favorable studies supporting the use of its Zilver PTX stent in the treatment of peripheral artery disease.
Results from both studies were presented this week at the Vascular Interventional Advances 2014 meeting in Las Vegas.
Here's a look at some of the top regulatory stories for medical device companies this week: FDA warns Cook Medical on 'nonconformance' issues; Abiomed jumps on FDA deal for Impella indication; Hansen Medical launches 3rd-gen Sensei surgical robot; Medtronic wins EU nod for Resolute Onyx stent
The FDA sends a warning letter to Cook Medical, saying inspections last summer turned up problems at a Bloomington, Ind., plant that makes vascular devices.
The FDA today released a warning letter it sent to Cook Medical last month, flagging problems found during inspections of a Bloomington, Ind., plant last summer.
Cook Medical promotes Jean-Marc Creissel to be vice president of its urology business.
Cook Medical said it promoted Jean-Marc Creissel to vice president of its urology business, which Creissel has led since 2010.
The FDA slaps its highest-risk Class I label on Cook Medical's recall of CloverSnare vascular retrieval snares.
The FDA issued a warning this month on Cook Medical's medical device recall, warning that a defect in certain of the company's CloverSnare 4-Loop Vascular Retrieval Snares could harm patients.
Federal device regulators gave the recall Class I status, reserved for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
Indiana-based Cook recalls its CloverSnare vascular retrieval snares after at least 6 complaints that the devices came apart during use.
Cook Medical announced this week that it recalled nearly 700 units of its CloverSnare 4-Loop Vascular Retrieval Snare devices after receiving complaints that the devices came apart during use.