Category: Cook Medical
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.
Cook Medical says it's begun enrollment in a clinical trial in China for its Zilver PTX peripheral stent.
Cook Medical said it enrolled the 1st patient in a 1st-of-its-kind clinical trial in China for its Zilver PTX drug-eluting peripheral stent as it looks to win approval for the device in the People's Republic.
Here's a look at some of the top regulatory stories for medical device companies this week: Debate heats up during FDA meeting over uterine surgical device and cancer risk; Merit Medical wins China OK for Aero device; Back in the USA: Cook Medical's Evolution lead extraction device returns; FDA flags Zynex Medical over chronic pain devices; FDA offers new guidance on 510(k) risk/benefit review
Cook Medical says its Evolution cardiac lead extraction device line is back on the U.S. market after a 2-month hiatus prompted by an FDA warning.
Cook Medical said today that it's Evolution RL and Evolution Shortie RL cardiac lead extraction devices are back on the U.S. market after a 2-month suspension prompted by an FDA warning issued last April.
Here's a look at some of the top regulatory stories for medical device companies this week: Senate Republicans want answers from FDA commish Hamburg on draft guidances; Medtech regulation: FDA releases April 2014 510(k) decisions; Prosthetic arm that translates muscle signals into action wins FDA approval; FDA warns Cook Medical on unapproved changes to Evolution lead extractor; FDA: Foreign medtech firms receive excess manufacturing violations.
The FDA sends a warning letter to Cook Medical, accusing the company of making unapproved changes to its Evolution RL lead extraction device.
The FDA last month accused Cook Medical of selling an unapproved device in the U.S., saying changes made to Cook Vascular's Evolution RL cardiac lead extraction device require the medical device company to file a new clearance application with the watchdog agency.
The Philadelphia Court of Common Pleas establishes a mass tort for all pelvic mesh lawsuits filed in its jurisdiction.
A Pennsylvania state judge ordered the creation of a mass tort this week to collect product liability lawsuits filed over pelvic mesh products against some of the largest names in medical devices.
Judge Arnold New, director of the Complex Litigation Center at the Philadelphia Court of Common Pleas, ordered Feb. 11 that "all currently filed pelvic mesh matters shall be transferred to the Complex Litigation Center Pelvic Mesh Mass Tort Program" for coordination, according to court documents.