A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
AdvaMed has reported that its member companies have provided $26.8 million in medical supplies, along with $4.1 million in cash donations.
Executive Vice President Geoff Martha will succeed Ishrak.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.
The Avalus pericardial surgical valve is intended for patients with aortic valve disease.
Medtronic will keep its respiratory and monitoring solutions business, while Cardinal will buy the patient care, DVT, and nutritional insufficiency businesses.
The adjustable devices have been the subject of an increased product complaint rate.
The technology helps doctors find the origin of an irregular heart rhythm.
The device expands treatment to an additional patient population.