FDA warns that problems with BioZorb Marker can cause users to suffer severe and potentially life-threatening complications from the bioabsorbable radiographic markers used for breast care and other exams
Recalled Medtronic Duet EVD systems led to an eight-fold increase in cerebrospinal fluid infections among patients at the hospital, according to findings outlined by CDC researchers.
FDA indicates that a recent update to the instructions constitutes a Class I recall, since problems with the Impella Blood Pumps can lead to severe injury or death
FDA has classified problems with the communication system as a Class 1 HeartMate recall, indicating that continued use of the device may pose a risk of serious injuries or death.
Magnets used in ResMed AirFit and AirTouch CPAP and BiPAP masks could put certain patients at risk of severe injuries or deaths, the FDA warns.
Fresenius must provide a response to the FDA warning letter within fifteen business days, or it may lose approval to manufacture hemodialysis machines.
Recalled Olympus Bronchofiberscope and Bronchovideoscope tubes are used to examine patients' lungs, but may catch fire during use and pose a risk of serious injury or death for patients.
FDA officials warn certain recalled Fresenius hemodialysis machines can leak toxic compounds into the bloodstream for up to a month after the devices are first put into service, posing serious and deadly risks to patients.
Injuries have been linked to the implantable devices failing to deliver therapy after they lost connection to patients' mobile devices after an MRI
The FDA is warning that the devices can shut down unexpectedly, but issued recommendations for their continued use by medical providers
