FDA Announces Recall of Heart Devices After 49 Deaths Reported

The U.S. Food and Drug Administration announced the recall of more than 66,000 heart pumps after dozens of deaths were reported, as the agency described it as the “most serious type of recall.” Abiomed, a subsidiary of pharmaceutical giant Johnson & Johnson, said in the FDA notice that it is recalling instructions for certain Impella left-sided blood pumps over serious safety issues that have led to 129 “serious injuries” along with 49 death reports. “During operations, the Impella device could cut through the wall of the left ventricle,” the company’s notice stated. “The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”...