Cook Medical announced today that it launched the next-generation MINC+ benchtop incubator in the U.S. and Canada. Bloomington, Indiana-based Cook Medical designed its MINC+ platform as the latest iteration of the MINC mini incubator benchtop system that has been in in-vitro fertilization (IVF) clinics for more than two decades. The latest version of MINC includes the […]
Cook Medical
Cook Medical wins FDA breakthrough designation for Thoraco+ endovascular system
Cook Medical today announced that its Zenith Thoraco+ endovascular system received FDA breakthrough device designation. Thoraco+ is the company’s next-generation endovascular graft that is indicated for the endovascular treatment of patients with thoracoabdominal aortic aneurysms. Get the full story on our sister site, Medical Tubing + Extrusion.
CooperCompanies to buy Cook Medical’s reproductive health business for $875M
Cook Medical has signed a letter of intent to sell its Reproductive Health business to CooperCompanies, the two companies announced today. CooperCompanies (NYSE:COO) plans to pay privately-held Cook Medical $875 million: $675 million at closing, then the remaining $200 million paid in four $50 million annual installments. The proposed deal — which could close in […]
Cook Medical wins FDA breakthrough designation for new drug-eluting stent
Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee. Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI). Get the full story on our sister site, Medical Tubing + Extrusion.
Cook Medical issues voluntary recall for transseptal needles, transseptal needles with catheter
Cook Medical this week announced a global voluntary recall of its Transseptal Needle and Transseptal Needle with catheter. Bloomington, Indiana-based Cook Medical issued the recall due to complaints of rust on the products. The use of both products could result in increased procedural time and inflammatory reactions, including systemic reactions that could lead to permanent impairment […]
Cook Medical warns on some Flexor Check-Flo introducer sheaths
Cook Medical recently issued a warning letter regarding an issue with its Flexor Check-Flo introducer catheters. Bloomington, Indiana-based Cook Medical field safety corrective action informs users that some of its introducer sheaths may be manufactured incorrectly and that the radiopaque marker band may be located just below the Check-Flo proximal fitting instead of the distal tip. Get the […]
Cook Medical selling powerful Quanta surgical laser in U.S.
Cook Medical announced that the Litho 150 laser from Quanta is now available in the U.S. through its distribution channels. Bloomington, Ind.-based Cook Medical said in a news release that the Litho 150 is the most recent product in Quanta’s line of laser systems and it complements Cook’s line of urologic stone management disposables. The […]
FDA committee to examine safety of endovascular stent grafts
FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood […]
Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. The designation — a first for Bloomington, Ind.–based Cook Medical — will enable priority review and better communication with FDA during the clinical trial and premarket review phases. […]
The worst catheter-based device recalls of 2020
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 […]
Cook Medical has a serious catheter recall
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). […]
