Category: Cook Medical
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.
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.
Cook Medical promotes Jean-Marc Creissel to be vice president of its urology business.
Cook Medical said it promoted Jean-Marc Creissel to vice president of its urology business, which Creissel has led since 2010.
The FDA slaps its highest-risk Class I label on Cook Medical's recall of CloverSnare vascular retrieval snares.
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."
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.