When it comes to medical devices, recalls can include not only “removals,” but also “corrections,” which address the problem in the field. By David Hilzenrath, KFF Health NewsAug 19, 2024 09:15am MedTech FDA issues Class 1 recall for Medtronic's nerve monitoring tech Medtronic said...
注1:https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls注2:https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices注3:https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medici...
The device, a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, “may spontaneously rupture during surgery,” according to the FDA recall. Class I recalls are the watchdog...
ingentaconnectGray Sheet
Today, the FDA categorized this action as a Class I recall, its most serious type, meaning that use could cause serious injuries or death. The devices are being recalled due to an unexpected and rapid decrease in battery life caused by a short circuit. This defect may case some devices to...
“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, ...
, FDA, Insulin Pump, Type 1 Diabetes, Type 2 Diabetes, Medtronic, FDA Recall, Medical Device Recalls, Medical Device RecallRelated Vitals Nobi Raises $37M in Series B Funding for AI-Driven Fall Detection Technology News February 4, 2025 MS Drugs Copaxone and Glatopa Get FDA ...
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’...
Customers are also asked to complete the enclosed acknowledgement form and fax it to 1-855-419-8507 (attention: customer service) or e-mail the form torecalls@teleflex.com. Customers with recalled product service will be contacted by a company representative with instructions for returning any rec...
biomedical safety & standards