TCTMD: Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA Abiomed has recalled the labeling for catheters used in its Impella RP Flex with Smart Assist System, the US Food and Drug Administration announced Thursday. The action comes from concern over a lack ... Label for Impella RP Flex Catheters Recalled to Address Anticoagulant Confusion: FDA Abiomed has initiated a voluntary recall for certain Automated Impella Controllers (AICs) used in conjunction with its Impella catheters following reports of one death as of 12 August in relation to a ...
On Thursday, Johnson & Johnson’s (NYSE:JNJ) Abiomed said it is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. Yahoo Finance: Abiomed’s latest Impella recall linked to 129 injury, 49 death reports Johnson & Johnson subsidiary Abiomed recalled its Impella left sided blood pumps for risk that the devices could perforate the heart during a procedure. The recall began on Dec. 27 with Abiomed ...
impella catheter, Yahoo: FDA posts early alert for safety issue with Impella heart pump devices
