The controllers are the primary user interface for Impella catheters. Using the controllers, physicians adjust and monitor ...

The FDA issued an early alert to notify the public of a potentially high-risk issue with J&J's Abiomed Automated Impella ...

Abiomed defeats Maquet in patent case over Impella heart pumps, marking second win since 2025—but recalls and FDA issues ...

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 ...

Certain Automated Impella Controllers (AICs), the main control interface for the Impella catheter (Abiomed/Johnson & Johnson MedTech), should not be used after another issue potentially affecting pump ...

The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction ...

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 ...

Review four medical device recalls to know from the FDA affecting heart pumps, ventilators, compounding systems and stent grafts in May 2024.

Johnson & Johnson has instructed users to remove certain Impella CP sets with SmartAssist from where they are used or sold. According to FDA, impacted lots include 613525, 644314, 645428, 644591, ...

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 ...

Recent developments of interest in cardiovascular medicine ...