Category: Cook MedicalSyndicate content

Manufacturers, medical societies team up for IVC filter study

November 13, 2014 by Brad Perriello

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.

Manufacturers, medical societies team up for IVC filter study

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.

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Cook Medical unveils 2 positive PAD studies for Zilver PTX

November 6, 2014 by Val Kennedy

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 unveils 2 positive PAD studies for Zilver PTX

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.

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FDA warning letter to Cook Medical finds problems during inspections of plant | Regulatory news for the week of November 3, 2014

November 4, 2014 by MassDevice

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

FDA warns Cook Medical on 'nonconformance' issues

October 28, 2014 by Brad Perriello

FDA warns Cook Medical on 'nonconformance' issues

October 28, 2014 by Brad Perriello

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.

FDA warns Cook Medical on 'nonconformance' issues

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.

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Cook Medical promotes Creissel to urology veep | Personnel Moves

September 25, 2014 by Brad Perriello

Cook Medical promotes Jean-Marc Creissel to be vice president of its urology business.

Cook Medical promotes Creissel to urology veep | Personnel Moves

Cook Medical said it promoted Jean-Marc Creissel to vice president of its urology business, which Creissel has led since 2010.

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Cook's recall gets FDA's highest-risk label

September 5, 2014 by Arezu Sarvestani

The FDA slaps its highest-risk Class I label on Cook Medical's recall of CloverSnare vascular retrieval snares.

Cook's recall gets FDA's highest-risk label

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."

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Cook Medical recalls retrieval device over embolization concerns

August 19, 2014 by Arezu Sarvestani

Indiana-based Cook recalls its CloverSnare vascular retrieval snares after at least 6 complaints that the devices came apart during use.

Cook Medical recalls retrieval device over embolization concerns

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.

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