Johnson & Johnson's Abiomed Issues Hardware Correction for Impella Controllers, FDA Classifies as Class I Recall
Johnson & Johnson's Abiomed issued a hardware correction for Impella heart pump controllers, involving four potential safety issues. The U.S. FDA classified it as a Class I recall because the issues could lead to interruption or delay in hemodynamic support, potentially causing serious injury or death. As of April 14, no related injuries or deaths have been reported.
At a Glance
- Johnson & Johnson's Abiomed has issued a correction for its Impella heart pump controllers after identifying a potential safety issue.
- The U.S. Food and Drug Administration disclosed the correction in a recall notice on Thursday, affecting Automated Impella controllers that require hardware updates.
- As of April 14, Abiomed has not reported any serious injuries or deaths, but the FDA classified this correction as a Class I recall because the issue could lead to serious harm.
In-Depth
The correction affects controllers used by physicians to adjust and monitor Impella heart pumps. During a retrospective review of repair records, Abiomed identified four hardware issues in the controllers that could pose safety risks. Abiomed notified customers of the issues in April.
The FDA noted in its recall notice that one issue involves the internal video graphics array (VGA) cable being too close to the digital signal processor chipset. Abiomed's repair team is installing Twist-Lok cable retainers to address this issue. For the remaining issues, the repair team will add flash card retainers, install clips to prevent fan wire damage, and add printed circuit board assemblies.
These hardware corrections aim to address issues that could cause the controller to fail to start or lead to sudden interruption of hemodynamic support. All four issues require users to replace the controller with an alternative device, which could further delay treatment.
"Delay or loss of hemodynamic support may have varying consequences depending on the patient's fragility and dependence on hemodynamics, and could lead to serious injury or death," the FDA stated.
In recent years, Abiomed has issued a series of corrections and recalls for Impella pumps and controllers. Last month, the FDA issued an early warning notice about a controller issue linked to two serious injuries and one death. That notice followed recalls and early warning notices for Automated Impella controllers issued by the FDA in July, August, September, and October of last year.
Johnson & Johnson acquired Abiomed in 2022 for $16.6 billion.