Hardware Updates Required to Address Potential Loss of Hemodynamic Support
Abiomed has issued a correction for certain Automated Impella Controllers (AICs) used with the Impella heart pump system after identifying hardware-related issues that could lead to controller startup failures or interruptions in hemodynamic support. The U.S. Food and Drug Administration (FDA) has classified the action as a Class I recall, the agency’s most serious recall category.
Importantly, this action is a device correction rather than a product removal. Hospitals may continue using affected Automated Impella Controllers while coordinating required hardware updates with Abiomed’s field service team.
Affected Device
Product: Impella Controller, Packaged, US
Product Code: 0042-0000-US
UDI-DI: 00813502010022
Affected facilities should review the manufacturer’s notification and verify whether any controller serial numbers in their inventory are included in the correction.
About the Automated Impella Controller
The Automated Impella Controller serves as the primary user interface for the Impella catheter system. The controller manages pump performance, provides alarms and system monitoring, and displays catheter positioning information during patient support.
Why the Correction Was Issued
During a retrospective review of service records, Abiomed identified several hardware-related issues that could potentially impair controller operation.
The identified issues are:
Potential electrostatic discharge interference affecting motor controls due to the proximity of an internal Video Graphics Array (VGA) cable to a Digital Signal Processor (DSP) chipset.
Potential dislodgement of the Compact Flash Memory Card, which could lead to startup failures or data logging issues.
Improper routing of internal fan wiring that could result in cable damage and console boot-up failures.
Capacitor-related issues within the Power Battery Manager assembly that could contribute to pump stop events, purge stop events, or fuse failures.
To address these concerns, Abiomed is implementing hardware modifications including cable retention devices, memory card retainers, improved wire routing controls, and updated Power Battery Manager circuit board assemblies.
Potential Patient Impact
According to the manufacturer, each of the identified hardware issues could result in a failure of the controller to boot properly, sudden interruption of hemodynamic support, and delays associated with exchanging the controller for a replacement device.
Because Impella systems are used to provide temporary mechanical circulatory support for critically ill patients, delays or loss of support may have significant clinical consequences depending on the patient’s hemodynamic status and dependence on the device.
The FDA notes in its recall notice that interruption or delay of hemodynamic support may result in serious injury or death.
As of April 14, Abiomed reported no serious injuries or deaths associated with these issues.
What Facilities Should Do
Abiomed has advised affected customers to continue using existing hospital inventory as needed to maintain continuity of care, work with Abiomed field service representatives to schedule return and modification of affected controllers, notify all personnel responsible for storing, transporting, maintaining, or operating affected devices, and forward the correction notice to any facilities that may have received affected products.
MDP Perspective
While no serious injuries or deaths have been reported, this correction highlights the importance of post-market surveillance and service record analysis in identifying hardware reliability issues before they result in widespread adverse events. The action also serves as a reminder that seemingly minor hardware design issues—including cable routing, component retention, and power management circuitry—can have significant implications when used in life-sustaining medical devices.
Facilities using Impella systems should ensure that affected controllers are identified and scheduled for corrective modification while maintaining adequate operational readiness for patients requiring mechanical circulatory support.
Links
Read the FDA’s announcement here.
Download the List of Affected Products
Intersurgical 22mm Smoothbore Breathing Tubes and Systems
FDA Issues Early Alert for Intersurgical Breathing Systems Over Potential Ventilation Failure. Manufacturing defect may cause breathing tube connectors to separate during use, potentially interrupting ventilation and exposing patients to serious injury or death.The...
FDA Early Alert: Teleflex/Arrow Guidewire
Affected guidewires and catheter products may release hydrophilic polymer particles into the bloodstream, potentially causing serious injury or death. No serious injuries or deaths have been reported.The U.S. Food and Drug Administration (FDA) has issued an Early...
FDA Investigates Cancer Risk with Zolgensma Gene Therapy
Postmarketing reports identify cases of tumor formation linked to gene therapy vector integration, prompting FDA to evaluate potential regulatory action.The U.S. Food and Drug Administration (FDA) is investigating a serious potential cancer risk associated with...
Eugia Vancomycin Recall: Glass Particle Contamination
FDA announces voluntary recall of a single lot of vancomycin hydrochloride for injection because of potentially dangerous particulate contamination.Eugia US LLC, formerly Auro Medics Pharma LLC, has initiated a voluntary nationwide recall of one lot of Vancomycin...
FDA Requires New GLP-1 Drug Warning for Vision Loss Risk
Agency cites potential increased risk of rare optic nerve condition following review of clinical trials and postmarket safety dataThe U.S. Food and Drug Administration (FDA) is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA)...
Class 1 Recall for HemosIL AcuStar HIT Antibody Test
HemosIL AcuStar HIT-IgG(PF4-H). Source: fda.govPerformance problems could produce false-negative results, potentially delaying diagnosis of a dangerous reaction to heparin.The U.S. Food and Drug Administration (FDA) has identified a recall of certain lots of the...