Dive Brief:
- Johnson & Johnson’s Abiomed has issued a correction for Impella heart pump controllers after identifying potential safety concerns.
- The correction, which the Food and Drug Administration disclosed in a recall notice on Thursday, covers Automated Impella Controllers that require hardware updates.
- As of April 14, Abiomed had not reported any serious injuries or deaths, but the potential for the issues to cause serious harm led the FDA to categorize the correction as a Class I recall.
Dive Insight:
The correction affects controllers that physicians use to adjust and monitor Impella heart pumps. In a retrospective review of servicing records, Abiomed identified four hardware issues with the controllers that could pose safety risks. Abiomed wrote to customers about the issues in April.
In its recall notice, the FDA said the proximity of the internal video graphics array cable to the digital signal processor chipset is one problem. Abiomed’s servicing team is installing Twist-Lok cable retention devices to fix the issue. The servicing team is addressing the other issues by adding a flash memory card retainer, installing a clip to prevent fan wire damage and adding a printed circuit board assembly.
The hardware corrections are intended to fix issues that could lead to a failure to boot the controller or a sudden interruption in hemodynamic support. All four issues would require users to swap the controller for a replacement device, further delaying treatment.
“Delay or loss of hemodynamic support can have different consequences depending on the vulnerability and hemodynamic dependency of the supported patient and may lead to serious injury or death,” the FDA said.
Abiomed has issued a series of corrections and recalls for Impella pumps and controllers in recent years. Last month, the FDA published an early alert notice about an issue with controllers linked to two serious injuries and one death. The notice followed a series of controller recalls and early alerts that the FDA posted last year.
J&J bought Abiomed for $16.6 billion in 2022.
