FDA Class I Recall

Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I)

Abiomed has initiated a Class I recall, the most serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a critical risk of purge system failure.

This recall involves the removal of affected devices from use and distribution, reflecting a high-risk failure mode that may result in serious injury or death if not addressed.

Affected Devices

The following products are included in the recall.

The Impella RP US Pump Set

Product Code: 004334

Serial Number: 434937A

UDI-DI: 00813502011029

Purge Cassette, 5 Pack (Generation 1)

Product Code: 0043-0003

UDI-DI: 00813502011135

Reason for Recall

Abiomed has identified an increased risk of purge cassette leaks in Generation 1 Purge Cassettes.

Device Function (Clinical Context)

The purge cassette is a critical component of the Impella system that delivers purge fluid to the catheter and prevents blood ingress into the microaxial pump motor as it maintains continuous device function during circulatory support.

The failure of the system directly compromises device reliability and patient safety.

Failure Mechanism

A purge cassette leak will lead to reduced purge pressure that can cause biomaterial ingress into the pump motor. That introduction of biomaterials will then cause an unexpected pump stop.

Clinical Impact

The clinical impact of the pump stopping is an immediate loss of hemodynamic support which will lead to the potential for rapid patient deterioration and a risk of patient death.

As of February 3, 2026, four serious injuries have been reported and no deaths were reported.

Required Actions for Healthcare Facilities

Immediate Actions

Identify and quarantine all Abiomed Impella Generation 1 purge cassettes, remove affected units from use, and initiate returns in accordance with Abiomed instructions.

Operational Guidance

Transition existing Impella devices to Generation 2 Purge Cassettes. If Generation 1 must be used, implement enhanced monitoring of purge system and respond immediately to a “Purge Pressure Low” alarm on Automated Impella Controller (AIC). Follow IFU instructions without deviation.

Communication and Control

Notify all relevant personnel (clinical, supply chain, biomedical) and inform any downstream facilities if product was redistributed. Post the recall notice in visible operational areas.

Manufacturer Contact Information

U.S. customers experiencing adverse events or requiring support should contact Abiomed by email at OneMD-Field-Actions@its.jnj.com.

Regulatory and Quality System Observations

This recall highlights several important QMSR / ISO 13485:2016 considerations.

Risk Management (ISO 13485 §7.1 / ISO 14971 integration)

Failure mode of a leak leading to a pump stop indicates a high-severity hazard chain and suggests potential gaps in design FMEA (DFMEA) and the verification of purge system integrity under real-world conditions.

Design & Development (ISO 13485 §7.3)

The transition from the Generation 1 to Generation 2 cassettes indicates a design corrective action and likely postmarket-driven design modification.

Postmarket Surveillance & CAPA (ISO 13485 §8.2 / §8.5)

Identification of field failures and injuries demonstrates an active complaint handling system that lead to a CAPA escalation and then a field action / recall.

Production & Process Controls (ISO 13485 §7.5)

Potential contributing factors may be material integrity issues, robustness of assembly processes, and a possible lack of leak-proof validation testing.

Advisory Notices (ISO 13485 §8.3.3)

This recall exemplifies proper execution of a Field Safety Corrective Action (FSCA) and product traceability via UDI-DI.

MDP Perspective

This event underscores a fundamental principle in life-sustaining device systems. Ancillary components (like purge cassettes) can represent single points of catastrophic failure. From a regulatory and quality standpoint, manufacturers should re-evaluate system-level risk interactions (not just component-level risks), strengthen alarm-response validation (human factors and system response time), ensure robust leak detection and prevention mechanisms, and incorporate real-world use conditions into design validation protocols.

Links

Read the FDA’s announcement here.