FDA issues recall on J&J heart device

(Reuters) – The U.S. Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve.

The valve, which prevents blood from flowing back through it, is part of a device used to insert and position cardiovascular catheters in the heart. (bit.ly/2A7nOIj)

About 110 Agilis Steerable Introducer Sheath devices made and distributed between Jan. 1 and May 5 are a part of the Class I recall, according to the FDA. (bit.ly/2lFe3N6)

Care Suffers As More Nursing Homes Feed Money Into Corporate Webs

MEMPHIS, Tenn. — When one of Martha Jane Pierce’s sons peeled back the white sock that had been covering his 82-year-old mother’s right foot for a month, he discovered rotting flesh.

“It looked like a piece of black charcoal” and smelled “like death,” her daughter Cindy Hatfield later testified. After Pierce, a patient at a Memphis nursing home, was transferred to a hospital, a surgeon had to amputate much of her leg.

Trump Administration Relaxes Financial Penalties Against Nursing Homes

The Trump administration — reversing guidelines put in place under President Barack Obama — is scaling back the use of fines against nursing homes that harm residents or place them in grave risk of injury.

The shift in the Medicare program’s penalty protocols was requested by the nursing home industry. The American Health Care Association, the industry’s main trade group, has complained that under Obama, inspectors focused excessively on catching wrongdoing rather than helping nursing homes improve.

“It is critical that we have relief,” Mark Parkinson, the group’s president, wrote in a letter to then-President-elect Donald Trump in December 2016.