Device Safety

Latest Headlines

Latest Headlines

Study finds smartphones can cause pacemakers and ICDs to malfunction

Research presented at a European conference found that wearers of cardiac devices should keep a safe distance from smartphones.

FDA panel slated to weigh Bayer Essure safety after more than 5,000 complaints

The U.S. Food and Drug Administration has further formalized its ongoing review of the controversial Essure permanent birth control implant from Bayer.

Medtronic recalls tracheotomy tubes due to problem that could result in difficulty breathing

Medtronic announced a large voluntary recall of its Shiley neonatal and pediatric tracheostomy tubes is underway due to a wider angle bend among affected models than in those manufactured after Nov. 29, 2012. It has suspended shipments of the faulty tubes.

FDA issues safety warning to cardiologists based on troubling post-market data

The FDA warned of higher mortality rates among patients on SynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.

Philips cautions on cardio mortality after ResMed sleep apnea data, intros cardiac imaging tool

Royal Philips said it is working with ResMed to analyze study data from mid-May showing that the latter company's Adaptive Servo-Ventilation central sleep apnea treatment worsens cardiovascular mortality for those in a particular subset of chronic heart failure data. Philips has a similar device, which it said is contraindicated in the relevant population with increased mortality: moderate to severe central sleep apnea patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than or equal to 45%.

DOJ slaps Olympus with a subpoena over dirty duodenoscopes

The U.S. Department of Justice subpoenaed Olympus Medical Systems in the latest portion of the long-unfurling saga of how and why duodenoscopes routinely used in colonoscopies and upper gastrointestinal tract examinations have continued to be a problematic source for the spread of deadly bacteria for years.

WSJ: J&J faces FBI probe over power morcellator devices

Johnson & Johnson is facing more backlash over power morcellator devices used in minimally invasive gynecological procedures, as the FBI investigates how much the company knew about the products' risks before pulling them from the market last year.

Issue that led to halt of St. Jude TAVR trial no cause for concern, EuroPCR experts say

St. Jude Medical suffered a rare withdrawal of the CE mark of its Portico transaortic aortic valve replacement last year and had to suspend its U.S. clinical trial for FDA approval. Now new data released from three studies at the annual EuroPCR conference in Paris should help St. Jude convince the FDA to resume that trial.

FDA reveals it's received 142 reports of contaminated duodenoscopes since 2010

In preparation for an upcoming meeting on duodenoscope safety, the FDA revealed it's received 142 reports of contaminated duodenoscopes since 2010.

Aetna curbs power morcellator coverage amid industry fallout

As the industry and regulators respond to public outcry over power morcellators used in minimally invasive gynecological procedures, one of the U.S.'s largest health insurers is curtailing its coverage of the device.