Category: Cook MedicalSyndicate content

Cook's recall gets FDA's highest-risk label

September 5, 2014 by Arezu Sarvestani

The FDA slaps its highest-risk Class I label on Cook Medical's recall of CloverSnare vascular retrieval snares.

Cook's recall gets FDA's highest-risk label

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."

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Cook Medical recalls retrieval device over embolization concerns

August 19, 2014 by Arezu Sarvestani

Indiana-based Cook recalls its CloverSnare vascular retrieval snares after at least 6 complaints that the devices came apart during use.

Cook Medical recalls retrieval device over embolization concerns

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.

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Cook Medical launches China trial for Zilver PTX peripheral stent

August 15, 2014 by Brad Perriello

Cook Medical says it's begun enrollment in a clinical trial in China for its Zilver PTX peripheral stent.

Cook Medical launches China trail for 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.

FDA meeting over uterine surgical device and cancer risk sparks debate | Regulatory news for the week of July 14, 2014

July 15, 2014 by MassDevice

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

Debate heats up during FDA meeting over uterine surgical device and cancer risk

July 11, 2014 by Ingrid Mezo

Back in the USA: Cook Medical's Evolution lead extraction device returns

July 10, 2014 by Brad Perriello

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.

Back in the USA: Cook Medical's Evolution lead extraction device returns

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.

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GOPers want answers on draft guidances | Medtech regulatory news for the week of May 12, 2014

May 13, 2014 by MassDevice

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.

Senate Republicans want answers from FDA commish Hamburg on draft guidances

May 8, 2014 by Brad Perriello

Senate Republicans want answers from FDA commish Hamburg on draft guidances

FDA warns Cook Medical on unapproved changes to Evolution lead extractor

May 7, 2014 by Brad Perriello

The FDA sends a warning letter to Cook Medical, accusing the company of making unapproved changes to its Evolution RL lead extraction device.

FDA warns Cook Medical on unapproved changes to Evolution lead extractor

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.

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