Spine Surgery | The FDA announced the Class I recall of the Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System in a press release and noted the system’s patient line tubing may separate from the patient line connectors...
CLASS I RECALL There isan updateto the recent Salmonella outbreak linked to eggs being recalled in nine states, including Minnesota. The FDA says there is 'reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.' EGG ...
“The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death,” the FDA notes in a MedWatch safety alert. The agency has classified the recall as Class I...
The US Food and Drug Administration (FDA) has identified a recall by Medtronic of theHeartWareVentricular Assist Device(HVAD) as Class I, indicating risk for serious injuries or death, because of the possibility of interruption in the electrical connection between the system's power source — the...
The US Food and Drug Administration (FDA) todayissueda class I recall of theSapien 3 Ultradelivery system, used to deploy the Edwards Lifesciences transcatheter heart valve in patients withaortic stenosis. Aspreviously reported, the device maker warned physicians last month that it had received an...
“There is a potential risk that the Impella motor housing may come into contact with the distal stent of [the TAVI device]. The contact may damage or destroy the motor’s impeller blades,” the FDA announced today. “The damaged Impella system may have reduced blood flow or pump stop, ...
The FDA has sent out a class one recall, the most serious level of recall, for Styrker’s Trevo XP ProVue retriever.
The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number ...
This prompted the FDA’s class I tag, the highest and most serious type of recall. “Even a single drop could result in reduced battery life, either immediately after the drop, or over time, and will continue to affect the pump even after replacing the battery,” Medtronic said in a ...
A Class I recall has been issued for the Tri-Flo Subglottic Suction System fromVyaire Medical. Use of these devices may cause serious injuries or death, the FDA reports. According to the FDA, there is a risk that the distal soft tip of the catheter may break off and enter the patient’...