FDA/CDC
FDA/CDC
Another FDA class I recall of Cardiosave Hybrid/Rescue IABPs
The coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown, without warnings or alarms to alert the...
FDA/CDC
FDA warns of potential problems with Abbott Trifecta valves
The FDA and Abbott warn about a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with...
FDA/CDC
FDA tweaks Impella indications on basis of postapproval study
The updated indication tightens the description of eligible patients on the basis of postapproval study results but in line with premarket-study...
FDA/CDC
FDA warns of clip lock malfunctions with MitraClip devices
Letters sent Sept. 8 by the FDA and Abbott Vascular, the device manufacturer, warn about an increase in reports that the device’s clip lock can...
News from the FDA/CDC
COVID to blame as U.S. life expectancy falls
The overall drop took national life expectancy from 78.8 years in 2019 to 77 years in 2020.
FDA/CDC
FDA clears endoscopic devices for sleeve gastroplasty, bariatric revision
The Apollo Endosurgery devices are the first and only ones approved for endoscopic sleeve gastroplasty and endoscopic bariatric revision, the...
FDA/CDC
Class I recall for Medtronic’s HeartWare HVAD batteries
Welding defects could cause separation of the two cell battery packs used to power the system, leading to power failure; one death has been...
FDA/CDC
FDA clears mavacamten (Camzyos) for obstructive hypertrophic cardiomyopathy
Mavacamten is a first-in-class allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of...
FDA/CDC
FDA warns of pump defect with Medtronic HVAD system
Patients with the ventricular assist device could develop pump thrombosis caused by a welding defect in the internal pump, the FDA said in a...
FDA/CDC
Congress opens investigation into FDA’s handling of a problematic heart device
The FDA took no decisive action even as safety problems with the LVAD persisted.
FDA/CDC
Medtronic recalls HawkOne directional atherectomy system
The Class I recall warns that the system’s catheter tip may break off or separate during use, which could lead to serious adverse events.