Dive Brief:
- Johnson & Johnson’s Abiomed has recommended updated use instructions for all of its Automated Impella Controllers in response to an issue linked to two serious injuries and one death.
- The action, which the Food and Drug Administration reported last week, relates to a situation in which controllers are forced to restart because of an internal software error.
- Abiomed is working on a software update to address the issue with the controllers, which have been the subject of a series of recall notices over the past year.
Dive Insight:
The controllers are the primary user interface for Impella catheters. Using the controllers, physicians adjust and monitor catheters that reduce the work of the heart and support the circulatory system, giving the organ time to recover.
In a letter sent to customers on May 14, Abiomed outlined conditions under which the controller may restart when a patient is being treated with one of its left ventricular Impella devices. During the restart, the controller screen turns black.
Based on preliminary data, Abiomed calculated that the controller stops for about 35 seconds, during which time the patient is unsupported by the Impella system, and regurgitation via the cannula may occur. The pump resumes automatically after the controller restarts. The problem cannot be resolved by swapping the crashed controller for another device.
Unless alternate mechanical support is in place, the pause in Impella activity could increase the risk of serious injury or death by depriving the patient of hemodynamic assistance, the FDA said. Abiomed reported two serious injuries and one death as of April 27.
Hospitals can continue to use the devices but should follow updated recommendations including advice on how to avoid restarts in patients additionally supported with venoarterial extracorporeal membrane oxygenation.
The letter, which the FDA reported in an early alert notice, extends a series of corrections and recalls related to Impella pumps and controllers. The FDA published multiple recall and early alert notices about Impella controllers last year. Abiomed asked customers to quarantine certain Impella devices early this year.
J&J has continued to increase Abiomed sales amid the problems, reporting 16.3% growth of the devices in the first quarter. Abiomed, which J&J bought for $16.6 billion in 2022, is part of a cardiovascular division that has driven growth at J&J’s medtech business in recent quarters.
