Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death. One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon. There were no deaths reported.

With healthcare costs continuing to rise, affordable and accurate imaging and diagnosis achieved through ultrasound will continue to attract patients, according to a new market report from Fact.MR. The report on the global market for ultrasound systems projects steady growth for the market from 2017 to 2022, from a value of $6 billion in 2017 to $7.8 billion toward the end of 2022 — a compound annual growth rate (CAGR) of 5.5 percent.