The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. The agency 2020 tagged a total of 33 medical device recalls as Class I — the most serious level — down from 49 in 2019. The list of the most serious catheter-based device recalls in 2020 includes products from … [Read more...] about The worst catheter-based device recalls of 2020
Boston Scientific
5 innovations to make duodenoscopes more single-use — and save lives
Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. (Here are five of the innovations.) Duodenoscopes are flexible, lighted … [Read more...] about 5 innovations to make duodenoscopes more single-use — and save lives
The top 10 catheter innovations of 2020
As the COVID-19 pandemic took over the world in 2020, medical device companies continued to showcase new catheter innovations. Throughout 2020, we saw FDA clearances, approvals and product launches for a variety of catheter-based technologies, including renal denervation systems, heart failure treatment catheters, mechanical thrombectomy systems … [Read more...] about The top 10 catheter innovations of 2020
Boston Scientific CEO Mike Mahoney talks Lotus decision, post-COVID outlook
Boston Scientific (NYSE:BSX) made waves this month when it recalled and retired its Lotus TAVR product line. Subsequent layoffs, first in Minnesota, then in Ireland, highlighted the impact of the decision to pull Lotus from the highly competitive market as a result of complexities related to the product delivery system and solely that — as the … [Read more...] about Boston Scientific CEO Mike Mahoney talks Lotus decision, post-COVID outlook
Boston Scientific throws in the towel on Lotus TAVR
Boston Scientific (NYSE:BSX) announced today that it has initiated a global, voluntary recall of its Lotus Edge aortic valve system — and is immediately retiring the Lotus program. Marlborough, Mass.-based Boston Scientific said in a news release that the recall of all unused inventory of its Lotus Edge transcatheter aortic valve repair (TAVR) … [Read more...] about Boston Scientific throws in the towel on Lotus TAVR
Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
Boston Scientific (NYSE:BSX) said it is recalling specific lots/batches of its Hurricane RX biliary balloon dilation catheters. Marlborough, Mass.-based Boston Scientific, which issued a warning letter from its international location in France, said the removal comes in response to an increase in complaints of the RX tunnel component (black … [Read more...] about Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
How fish physiology is enabling Boston Scientific to help atrial fibrillation patients
Company researchers developed cardiac ablation technology that mimics the navigation system of electric fish. Scientists have studied electric fish for decades to determine how and why they discharge electricity. Recently, a couple of biomedical engineers at Boston Scientific realized that the way these fish use their electrical impulses … [Read more...] about How fish physiology is enabling Boston Scientific to help atrial fibrillation patients
Boston Scientific launches DirectSense technology
Boston Scientific (NYSE:BSX) announced today that it launched its DirectSense for monitoring the effect of radiofrequency (RF) energy during cardiac ablation procedures. Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local … [Read more...] about Boston Scientific launches DirectSense technology
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
Study: Boston Sci’s Watchman cheaper than drugs long-term
A new study has found that use of the Boston Scientific (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device to treat atrial fibrillation costs less than existing and novel anticoagulant drugs over five years. The retrospective study pooled data from the randomized trials of the Marlborough, Mass.-based company’s Watchman device. The … [Read more...] about Study: Boston Sci’s Watchman cheaper than drugs long-term
