Two separate randomized trials of Johnson & Johnson’s miniaturized Impella heart pumps failed to illustrate the devices’ benefits, spanning specific cases in patients with blockages in their coronary ... Yahoo: FDA posts early alert for safety issue with Impella heart pump devices Johnson & Johnson’s Abiomed has asked customers to quarantine certain Impella devices over a risk linked to four serious injuries, the Food and Drug Administration said Wednesday. Abiomed wrote to ...
FDA posts early alert for safety issue with Impella heart pump devices Johnson & Johnson (NYSE:JNJ) reported results from the randomized STEMI DTU trial of its Impella CP device at ACC 2026. The study assessed use of Impella CP before coronary intervention in heart ... The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement.
impella device, MedTech Dive: J&J’s Impella heart pump shows no patient benefit in 2 trials Study investigators cautioned against routine use of the device in complex percutaneous coronary interventions and to treat heart attack patients who don’t have cardiogenic shock.
