The manufacturer has identified that certain Abiomed heart pumps with differential pressure sensors have the potential to display inaccurate information.

Johnson & Johnson’s Abiomed has sent an urgent medical device correction about a malfunction risk linked to 22 reports of ...

The FDA issued an early alert related to updated instructions for certain Impella devices from Johnson & Johnson MedTech’s Abiomed.

The agency says there have been 22 injuries and no deaths associated with this potentially high-risk device issue.

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 ...

The FDA has issued an early alert warning of a potentially high-risk issue affecting certain Abiomed heart pumps. The agency said Abiomed issued an urgent medical device correction Jan. 27 for all ...

Last week, the FDA announced it was aware that Abiomed had sent a letter to affected customers recommending updated instructions for use for all Automated Impella Controllers (AIC). Abiomed identified ...

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.

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.

Physicians forced to make rapid-fire choices, with limited evidence, in acute myocardial infarction complicated by cardiogenic shock (AMICS) finally have what they’ve long been waiting for: positive ...