FDA: Medtronic heart device could malfunction
Medtronic this week alerted health care providers to a defect in its Heartware Ventricular Assist Device System that may cause the internal pump to malfunction, the Food and Drug Administration announced yesterday. The company is investigating to determine which devices may be affected. FDA recommends that health care providers and patients make decisions about removing or exchanging the device on a case-by-case basis, considering the patient’s clinical status and surgical risks.
Related News Articles
Headline
Kelley Sava, associate vice president of simulation at Advocate Health, and Brian Bjoern, M.D., patient safety manager at Laerdal Medical, share how simulation…
Headline
To help hospitals across the country improve sepsis care, the Centers for Disease Control and Prevention created the Hospital Sepsis Program Core Elements,…
Headline
The Food and Drug Administration today issued an alert on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid…
Headline
In this conversation, Carlos Roberts, M.D., urogynecologist, vice president and chief medical officer of the Women and Children service line at WellSpan Health…
Headline
In this “Safety Speaks” conversation, CommonSpirit Health's Beth Miller, system director, patient safety-performance improvement, and Austin Peterson, system…
Headline
The Food and Drug Administration Feb. 23 withdrew approval of Pepaxto (melphalan flufenamide), a drug once used with dexamethasone to treat certain U.S.…