The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen catheter is identified as Class I, the most serious kind of recall. Vascular Solutions, a Teleflex (NYSE:TFX) subsidiary, designed the Langston dual lumen catheter for the rapid delivery of dye into blood vessels during medical imaging tests, … [Read more...] about Vascular Solutions recall of Langston dual lumen catheter is Class I
Catheters
Cagent Vascular wins FDA clearance for balloon catheter
Cagent Vascular announced that it received FDA 510(k) clearance for its Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. The FDA indication is for use of the Serranator for treating below-the-knee (BTK) lesions, making it the first and only angioplasty balloon with FDA clearance and CE Mark approval that embeds … [Read more...] about Cagent Vascular wins FDA clearance for balloon catheter
How catheters are becoming increasingly complex and efficient
As the neurovascular intervention marketplace accelerates toward miniaturization, innovations such as 2.5:1 peelable heat-shrink tubing (PHST), cut-to-length PHST and multi-filar active catheter solutions will come into their own. Joe Rowan, Junkosha Catheters are becoming increasingly complex in terms of the procedures they can be used … [Read more...] about How catheters are becoming increasingly complex and efficient
Boston Scientific has a Class I recall of angiographic catheters
The FDA has issued a Class I designation for a recall involving the Imager II 5F angiographic catheters produced by Boston Scientific (NYSE:BSX). Marlborough, Mass.-based Boston Scientific’s catheters are designed to provide a pathway for delivering contrast agents to blood vessels including carotid arteries. Get the full story at our sister … [Read more...] about Boston Scientific has a Class I recall of angiographic catheters
LeMaitre Vascular recall of embolectomy catheters is Class I
The FDA identified the recall of LeMaitre Vascular (NSDQ:LMAT) Over the Wire embolectomy catheters for a failure to deflate as a Class I recall. Burlington, Mass.–based LeMaitre Vascular's Over the Wire embolectomy catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that … [Read more...] about LeMaitre Vascular recall of embolectomy catheters is Class I
What is medical tubing used for?
Medical tubing allows clinicians to administer fluid and or even devices — as well as potentially allow for gas flow. And that's just the beginning. Common applications of medical tubing include ventilators and IVs, but tubing also finds uses supporting access devices and as a delivery method for other devices. For example, tubing can be used to … [Read more...] about What is medical tubing used for?
What is cardiac catheterization?
Cardiac catheterization is a procedure in which a catheter is inserted into an artery or vein in the groin, neck or arm and threaded to the heart. Diagnostic tests can be performed using the catheter during catheterization, according to the Mayo Clinic. Coronary angioplasty and coronary stenting are also performed using cardiac … [Read more...] about What is cardiac catheterization?
Teleflex warns on Arrow multi-lumen catheter
Teleflex (NYSE:TFX) this week initiated a voluntary field safety corrective action in Europe for its Arrow subsidiary's multiple-lumen catheter. In a field safety notice dated March 16, Teleflex announced that Arrow is voluntarily recalling the catheter due to a potential sterility issue. The catheter's product tray may be damaged in affected … [Read more...] about Teleflex warns on Arrow multi-lumen catheter
Reflow Medical lands 510(k) for expanded indication for Wingman catheter
Reflow Medical recently announced that it received FDA clearance for expanded indication of its Wingman Crossing Catheter. The Wingman Catheter is designed to cross peripheral CTOs using an extendable beveled tip that creates a channel to help penetrate or cross the occlusion was a guidewire. Reflow Medical received expanded indication for the … [Read more...] about Reflow Medical lands 510(k) for expanded indication for Wingman catheter
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve … [Read more...] about Abbott wins CE Mark for FlexNav delivery system