The FDA issued a Class I recall status, its most serious, to medical device maker ConvaTec for its fecal management system that is blamed for one death and a dozen injuries. The company began its own recall of the system, which was not cleared for marketing by the FDA, in April.
Covidien has issued a recall of its Hydrofinity Hydrophilic Guidewire due to the potential for damage to the outer polymer jackets of the device during use. The company said it has notified the FDA of the action.
CareFusion's Alaris pump is again the subject of a recall, earning the FDA's most serious designation over a software problem that can muddle scheduled infusions and put patients at risk.
Add two more Abbott Laboratories diabetes products to the list of items deemed potentially deadly by the FDA. Five of the company's diabetes offerings have now been subject to the agency's most serious recall label in the past year.
"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal 's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.
Danish medical device maker Coloplast is said to have paid $16 million to settle lawsuits claiming it injured women with vaginal-mesh inserts. With settlement talk swirling around at least 5 more makers of the plagued devices, that has some watchers saying the time may be ripe for a global settlement.
Johnson & Johnson's Ethicon division won big in an ongoing suit regarding its vaginal mesh implants: After one week of testimony, a federal district judge in Charleston, WV, ruled that the company's pelvic mesh product did not cause injury.
A Teleflex subsidiary is voluntarily recalling one of its tracheal tubes because of reports that it can kink during use and cut off a patient's air supply. The FDA slapped its Class I recall designation on the Pennsylvania company's action, meaning the defect carries with it a risk of major injury or death.
Tandem Diabetes Care is expanding a voluntary recall of specific lots of insulin cartridges used with its t:slim insulin pump. The cartridges may be at risk of leaking, resulting in over- or under-doses of insulin.
Abbott Laboratories is in the midst of a voluntary recall of some test strips for its blood glucose meters, and now the FDA is warning that use of the faulty products could lead to serious injury or death.