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Cook Medical

The worst catheter-based device recalls of 2020

February 19, 2021 By Danielle Kirsh Leave a Comment

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]

Filed Under: Catheters, Featured, Food & Drug Administration (FDA), Recalls Tagged With: Abbott Vascular, Applied Medical, Arrow International, Boston Scientific, Cook Medical, Endologix, LeMaitre Vascular, Medtronic, Teleflex, Vascular Solutions

Cook Medical has a serious catheter recall

December 28, 2020 By Chris Newmarker

FDA has designated Cook Medical‘s recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level. Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). […]

Filed Under: Catheters, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: Cook Medical

Cook Medical launches global catheter introducer recall

December 3, 2020 By Nancy Crotti

Cook Medical has launched a voluntary recall of nearly 59,000 devices intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The Flexor Check-Flo introducer and Flexor Tuohy-Borst side-arm introducer (Shuttle Select) are sterile, single-use devices that incorporate a hydrophilic-coated shaft in varying stiffnesses with distal radiopaque markers. The recall covers […]

Filed Under: Business/Financial News, Featured, Recalls Tagged With: Cook Medical

Cook Medical announces U.S. launch of balloon for transnasal esophageal procedures

October 26, 2020 By Danielle Kirsh

Cook Medical today commercially launched its Hercules 100 Transnasal Esophageal Balloon in the U.S. The balloon is designed specifically for trans nasal esophageal procedures and is another tool for ENT physicians to help treat esophageal strictures. “This balloon was specifically designed with ENT physicians and their patients in mind. The balloon is much shorter than […]

Filed Under: Implants Tagged With: Cook Medical

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]

Filed Under: Business/Financial News, Drug-Device Combinations, Drug-Eluting Stents, Featured, Regulatory/Compliance, Stents, Vascular Tagged With: B. Braun, Biosensors International Group Ltd., Biotronik, Boston Scientific, Cook Medical, FDA, Lutonix Inc., LVD Biotech, Medtronic, Spectranetics Corp., U.K.medicinesandhealthcareproductsregulatoryagency

Cook Medical issues Class I recall of CrossCath Support Catheters

December 17, 2019 By Danielle Kirsh

Cook Medical is recalling its CrossCath Support catheters due to potential marker bands dislodging or buckling in a Class I recall. Cook Medical said an error occurred during manufacturing that could cause radiopaque marker bands to be too loose on some CXC3.0 CrossCath Support Catheters and could be too tight on certain CXC3.4 CrossCath Support […]

Filed Under: Cardiovascular, Catheters, Recalls Tagged With: Cook Medical

Study: Stents no better than drugs for stable heart disease

November 18, 2019 By Nancy Crotti

This article has been updated with stock market results and comments from Medtronic. A major new study has concluded that the use of stents in stable heart disease patients is no better than drugs to treat clogged arteries. Results of the Ischemia study were released at the American Heart Association annual meeting in Philadelphia on Saturday. The […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Eluting Stents, Featured, Stents, Vascular Tagged With: Abbott, American Heart Association, B. Braun, becton dickinson, Boston Scientific, Cardinal Health, Cook Medical, Medtronic, MicroPort Scientific, Society for Cardiovascular Angiography & Intervention, Terumo

Cook Medical India opens new facility in Chennai

November 4, 2019 By Sean Whooley

Cook Medical India has opened a new office facility at Kochar Jade in Guindy, Chennai, in the city’s major business district. The modern, 20,000-square foot office is slated to host training facilities with up-to-date video conferencing equipment and presentation aids that support collaborative learning, the company said in a news release yesterday. The location is also […]

Filed Under: Business/Financial News, News Well Tagged With: Cook Medical

New FDA guidance out for vascular device labels

October 10, 2019 By Nancy Crotti

The FDA has issued two new final guidance documents governing labels for a variety of intravascular devices. One covers labels for intravascular catheters, wires, and delivery systems with lubricious coatings, and the other is for coronary, peripheral and neurovascular guidewires. Intravascular devices with hydrophilic or hydrophobic coatings may offer physicians greater maneuverability within blood vessels, and […]

Filed Under: Featured, Food & Drug Administration (FDA), Recalls, Vascular Tagged With: Cook Medical, FDA, Medtronic, SentreHeart

Cook Medical touts paclitaxel-coated stent PAD study results

September 10, 2019 By Sean Whooley

Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to […]

Filed Under: Clinical Trials, Drug-Device Combinations, Drug-Eluting Stents, Featured, Food & Drug Administration (FDA), News Well, Vascular Tagged With: Cook Medical, FDA

Cook Medical relaunches Beacon Tip catheters in Europe

September 3, 2019 By Nancy Crotti

Cook Medical said today that has relaunched its Beacon Tip catheters in Europe, three years after withdrawing them from the market worldwide. The catheters are now available in the UK, Ireland, Norway, Sweden, Finland, Denmark, Germany, Poland, the Netherlands, Luxembourg, Belgium, France, Switzerland, Austria, Hungary, Spain and Italy. Cook said it is working on relaunching […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, News Well, Recalls Tagged With: Cook Medical

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