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
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.…
Headline
AHA today submitted comments on how the Agency for Healthcare Research and Quality can best support the field in advancing patient safety through an…
Headline
Abbott has recalled certain lots of its Dragonfly OpStar imaging catheter because a marker band may separate from the catheter and remain in the patient after…
Headline
AHA today urged the Federal Trade Commission to scrutinize commercial health plans that steer patients to third-party specialty pharmacies in which they have a…
Headline
The Food and Drug Administration last week extended to 24 months the shelf life for certain lots of refrigerated bamlanivimab. The combination monoclonal…