Cook Medical has issued a letter to customers recommending the removal of certain sizing catheters from where they are used or sold. Affected devices include the company's Centimeter, Aurous Centimeter and Beacon Tip Centimeter sizing catheters. (The FDA website contains a full list of affected lots.) Sizing catheters offer use in … [Read more...] about Cook Medical warns on certain sizing catheters
Cook Medical
Cook Medical commercially launches two new urology products
Cook Medical commercially launched two new urology products, the Syfonix suction ureteral access sheath and the 7.5 Fr Ascend single-use flexible ureteroscope, according to the company. Syfonix and Ascend are both single-use products used in ureteroscopic kidney stone management procedures and a part of Cook’s larger portfolio of urological … [Read more...] about Cook Medical commercially launches two new urology products
Cook Medical launches new endoscopy products
Cook Medical this week announced the U.S. and Canadian launches of its Cold AcuSnare polypectomy snare and Caesar alligator rat tooth grasping forceps, both for endoscopic GI procedures. The Cold AcuSnare is also available in direct markets in Europe. Cook Medical officials say the launches make the Bloomington, Indiana–based medtech … [Read more...] about Cook Medical launches new endoscopy products
Cook treats final patient in endovascular graft study
Cook Medical announced that it enrolled the final patient in the global clinical study of its Zenith Fenestrated+ Endovascular Graft (ZFEN+). ZFEN+ won FDA investigational device exemption (IDE) in June 2023. This study, conducted under that IDE, assesses ZFEN+'s safety and effectiveness used in combination with the investigational Zenith … [Read more...] about Cook treats final patient in endovascular graft study
Cook Medical angiographic catheter recall is Class I
The FDA has designated Cook Medical's recall of its Beacon Tip 5.0 Fr angiographic catheter as Class I, the most serious level. Users reported tip separation occurring both before and during patient contact, according to an FDA notice published today. As a result, catheter fragmentation and embolization might occur with the catheters involved in … [Read more...] about Cook Medical angiographic catheter recall is Class I
Cook Medical warns of issue with angiographic catheter
Cook Medical issued an urgent field safety notice in Europe to warn of an issue with its Beacon Tip 5.0 Fr angiographic catheter. The company identified an issue in which affected device lots may experience tip separation. This prompted Cook to request that customers remove devices from use, quarantining them and returning them to the … [Read more...] about Cook Medical warns of issue with angiographic catheter
Merit Medical completes acquisition of Cook Medical’s lead management portfolio
Merit Medical Systems (Nasdaq:MMSI) announced today that it completed its acquisition of Cook Medical’s lead management portfolio. South Jordan, Utah-based Merit announced its agreement to buy the portfolio for $210 million in September. Merit funded the acquisition through a combination of cash on hand and borrowings under a long-term credit … [Read more...] about Merit Medical completes acquisition of Cook Medical’s lead management portfolio
Cook Medical launches IVF device in U.S.
Cook Medical announced today that it launched its NestVT vitrification device for in-vitro fertilization (IVF) in the U.S. Bloomington, Indiana-based Cook designed NestVT as a secure solution for embryos and oocytes during vitrification, cryo-storage and relocation. The company says the launch coincides with an effort to become a trusted IVF … [Read more...] about Cook Medical launches IVF device in U.S.
Merit Medical to buy Cook Medical’s lead management portfolio
Merit Medical Systems (Nasdaq:MMSI) announced today that it agreed to acquire Cook Medical's lead management portfolio for $210 million. Cook Medical's lead management business provides medical devices and accessories used in lead management procedures. These procedures occur in patients who need a pacemaker or an implantable … [Read more...] about Merit Medical to buy Cook Medical’s lead management portfolio
Cook Medical wins DOD contract for drug-eluting stents
Cook Medical announced today that the U.S. Dept. of Defense (DOD) awarded it an ECAT contract for implantable medical devices. The contract includes implantable vascular medical devices like the Zilver PTX drug-eluting peripheral stent. It also applies to the Zenith aortic endografts and associated interventional devices for treating vascular … [Read more...] about Cook Medical wins DOD contract for drug-eluting stents
