Abiomed has issued a warning about an issue with its Automated Impella Controller devices following a reported patient death. The issue stems from a manufacturing defect in certain units’ pump driver ...
Add Yahoo as a preferred source to see more of our stories on Google. Abiomed's Impella 2.5 heart pump helps maintain blood flow during high-risk heart procedures or cardiac shock. Johnson & Johnson ...
Abiomed, part of Johnson & Johnson MedTech, has identified an issue that may affect the detection of its Impella pumps when connected to their controllers, according to an alert put out by the US Food ...
Abiomed identified an issue where the AIC may fail to detect an Impella pump when connected. This pump detection issue can occur during console-to-console transfer or at the start of a case.
Abiomed has issued a recall alert after identifying a cybersecurity risk with its Automated Impella Controllers. In an Oct. 1 alert to customers, the manufacturer directed users to disable the ...
Abiomed is taking certain Impella Controllers off the market due to failing circuitry. One related death has already been reported, the FDA alerted. Medtronic announced FDA approval of a redo ...
The issue of faulty Automated Impella Controllers was elevated to a class I recall by the FDA, following five serious injuries. The agency also revised the label for fenofibrates to remove language ...
Add Yahoo as a preferred source to see more of our stories on Google. The Food and Drug Administration issued an early alert for a correction of Abiomed's Impella RP Flex heart pumps. (Courtesy of ...
DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart ...