Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV). The Wattson guidewire is designed to simplify and shorten procedures by eliminating the need for the routine use of central venous access and transvenous temporary pacing […]
Teleflex
Teleflex’s UroLift wins new FDA designation
Teleflex (NYSE:TFX) said today that the FDA has granted the company an expanded indication for the use of its UroLift system to treat larger prostates, between 80cc and100cc. UroLift is a minimally invasive, in-office treatment designed to provide rapid relief and recovery from the symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate. Symptoms may […]
Teleflex warns on Arrow EZ-IO needle sets
Teleflex (NYSE:TFX) today issued a safety warning in the United Kingdom for its Arrow EZ-IO intraosseous vascular access needle sets due to a risk of needle stick injury. The company informed users that they should not use the affected needles if the safety cap is not in place, due to a risk of needle stick […]
Teleflex says infant breathing device it distributes is recalled
Teleflex (NYSE:TFX) today announced a recall of a device used to help newborns with infant respiratory distress syndrome to breathe. Teleflex is one of the U.S. distributors of the device, the Babi.Plus 12.5 cm H2O pressure relief manifold, manufactured by GaleMed. The FDA has designated the recall as Class I. The recall began June 14 […]
Massive Teleflex endotracheal tube recall extends to Centurion Medical Products
A Class I recall of 6 million Teleflex (NYSE:TFX) Sheridan endotracheal tubes and connectors indicated for use on patients under general anesthesia has expanded to include connector kits manufactured by Centurion Medical Products, according to the FDA. Teleflex began recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes in June 2019 due to complaints of the Sheridan […]
Teleflex stock up on Street-beating Q2 earnings
Teleflex (NYSE:TFX) posted second-quarter results today that beat the consensus forecast on Wall Street, sending its stock up more than 6% in value. The Wayne, Pa.–based company — maker of medical devices for vascular and interventional access, surgical, anesthesia, cardiac care and more — also reported positive clinical study data related to Teleflex’s Manta vascular closure […]
Teleflex ticks up on Q2 beats, raised outlook
Teleflex (NYSE:TFX) posted a swing to second-quarter black ink today, topped the consensus forecast for both sales and earnings and raised its top-line outlook for the rest of the year, sending share prices up on Wall Street today. The Wayne, Pa.-based medical device giant reported profits of $83.4 million, or $1.77 per share, on sales growth […]
Teleflex recalls neonatal breathing devices
Teleflex (NYSE:TFX) is recalling its Neonatal ConchaSmart breathing circuit with dual heated limb and ConchaSmart Column due to complaints of cracks being observed, prior to use, on the device’s swivel wye adaptors. Cracks in the adaptor may cause breathing distress from insufficient oxygenation because the gas may leak and not reach the patient. The FDA has […]
Teleflex touts large real-world UroLift study
Teleflex (NYSE:TFX) yesterday touted results from a real-world study of its UroLift system for treating prostate disease. The UroLift implant is designed to treat lower urinary tract symptoms from benign prostatic hyperplasia. Wayne, Pa.-based Teleflex paid $1 billion to acquire NeoTract, which developed UroLift, in October 2017. The 1,413-patient retrospective study was designed to evaluate UroLift’s […]
Sterigenics moves to upgrade shuttered device sterilization plant
Sterigenics said today that it has applied for permits to upgrade emissions controls at its Willowbrook, Ill. medical device sterilization plant, which had sterilized thousands of devices daily until its Feb.15 shutdown. The Illinois Environmental Protection Agency (EPA) closed the Willowbrook plant, citing excessive emissions of the sterilant ethylene oxide (EO), based on a federal […]
Two deaths reported in recall of 6 million Teleflex endotracheal tubes
Teleflex (NYSE:TFX) is recalling multiple models of its Hudson RCI Sheridan and Sheridan endotracheal tubes due to complaints of the Sheridan connector disconnecting from the breathing circuit. Two deaths and one injury have been reported to the company, according to the FDA. Each of the more than 6 million recalled tracheal tubes includes an appropriately sized […]