FDA alerts of risk with Calyxo aspiration systems
The Food and Drug Administration today issued an on a potentially high-risk issue with Calyxo CVAC Aspiration Systems. In patients who have thick fluid in their kidneys at the start of the procedure, the system can cause reduced fluid overflow, potentially leading to excessive pressure in the kidneys. Serious death or injury could occur if the increased pressure is not addressed. Calyxo has reported one death associated with the issue.
Related News Articles
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鈥
Headline
In this 鈥淪afety Speaks鈥 conversation, CommonSpirit Health's Beth Miller, system director, patient safety-performance improvement, and Austin Peterson, system鈥
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.鈥
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鈥
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鈥
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鈥