Automated Impella Controller Software Defect Affecting Pump Connection Detection
Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a cardiac support device with a software defect that creates a risk of serious patient harm. No illnesses or injuries are reported in the available source material, placing it in the 'High' category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
The Automated Impella Controller (AIC, product number 0042-040-US) is a cardiac support system that manages a miniature heart pump used in acute and critical care settings. Abiomed is recalling units with software versions V8.4 and V8.4.1.
A software defect in these versions prevents the controller from properly detecting when the pump is connected. This detection failure could result in the pump not being recognized by the system, potentially leading to inadequate patient monitoring or device malfunction.
Affected units have serial numbers IC8386, IC8391, and IC8617. The recalled devices were distributed to healthcare facilities in Arizona, California, Florida, New York, and Virginia.
Healthcare providers should contact Abiomed immediately for instructions on obtaining a software update or replacement controller. Patients using these devices should consult with their healthcare team regarding any necessary actions.
The recalled product
- Product
- Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
- Manufacturer
- Abiomed, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI (GTIN): 00813502011401
- serial numbers IC8386
- IC8391 and IC8617.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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