FDA Class I Recall

Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings

Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance data.

The U.S. FDA has classified this action as a Class I recall, indicating that continued reliance on affected device outputs without following updated instructions may result in serious injury or death.

What Is the Issue?

The correction involves a potential malfunction of the differential pressure (dP) sensor, which is used to calculate and display key hemodynamic parameters. If sensor drift occurs over time, the system may display inaccurate values, including the pump flow rate, pulmonary artery (PA) placement signal, pulmonary artery pulsatility index (PAPi), and central venous (CV) placement signal.

These inaccuracies may lead clinicians to make inappropriate clinical decisions, including incorrect pump setting (P-level) adjustments or unnecessary pump exchanges.

Importantly, the issue does not affect the pump’s ability to provide hemodynamic support, but rather the accuracy of displayed data used for clinical decision-making.

Affected Devices

Devices affected by the correction are the Impella RP with SmartAssist and the Impella RP Flex with SmartAssist. The devices are temporary heart pumps used in hospital settings to provide right ventricular support in patients with acute right heart failure.

Reported Adverse Events

As of January 15, there were 22 serious injuries and no deaths reported.

Required Actions for Clinicians

Abiomed and the FDA recommend that clinicians should not rely solely on Automated Impella Controller (AIC) displayed values. Instead, patient management should be guided by independent clinical assessment. Monitor patient hemodynamics with approved diagnostic devices and verify the device positioning by using imaging prior to clinical intervention.

Pump performance should be evaluated using P-level flow rates provided in the Instructions for Use (IFU) rather than displayed values on the AIC. Clinicians should also trend pump metrics over time, recognizing that abrupt changes or discrepancies may indicate issues with positioning, patient condition, or pump performance.

Healthcare facilities are advised to distribute this information to all relevant personnel and ensure awareness across teams responsible for device use, storage, and transport.

Contact Information

For questions or adverse events, contact Abiomed, Inc. by email at onemed-field-actions@its.jnj.com.

MDP Analysis

This correction highlights several critical regulatory and quality system considerations.

Software / Data Integrity (IEC 62304)

Although the device hardware continues to function, the issue lies in data accuracy and interpretation, a core concern in software-driven medical devices. This is a classic example of correct therapy, incorrect data, and a high-risk scenario for clinical decision-making.

Risk Management (ISO 14971)

The failure mode reflects insufficient control of sensor drift over time and the risks associated with overreliance on displayed parameters. This aligns with hazards related to incorrect clinical decisions and misinterpretation of device output.

Human Factors and Clinical Workflow

Clinicians may naturally rely on device-displayed values, and this event underscores the need for redundant verification (imaging, diagnostics), clear labeling of device limitations, and clinician training on data interpretation vs direct measurement.

Post-Market Surveillance

The identification of 22 serious injuries demonstrates the importance of real-world performance monitoring and the role of trend analysis in detecting latent system issues.

System-Level Insight

This is not a mechanical failure; it is a measurement and feedback loop failure. In modern devices, data is relied on for decision making, so data integrity is closely tied to patient safety.

Bottom Line

This correction reinforces a critical principle in advanced medical devices, that safe device performance depends not only on mechanical function, but also on the accuracy and reliability of the data used to guide clinical decisions. Manufacturers must ensure that sensor performance remains stable over time, data limitations are clearly communicated, and risk controls account for clinical reliance on displayed values.

Links

Read the FDA’s announcement here.