Automated Impella Controller Software Issue Prevents Pump Detection
Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. 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 an FDA Class II recall of a cardiac support device where a software issue prevents pump-controller detection. No illnesses or injuries have been reported, making this a risk-of-harm product without confirmed harm, meeting the High (3) criteria.
Plain-English summary
Abiomed, Inc. is recalling Automated Impella Controller (AIC) product number 0042-000-US with software versions V8.4 and V8.4.1 due to a software issue.
The software issue may prevent the pump from being detected as connected to the controller. This detection failure could impact proper device operation and monitoring capabilities.
The affected devices were distributed in the United States to Arizona, California, Florida, New York, and Virginia. The serial numbers affected by this recall are IC3772, IC3773, IC5721, and IC4404.
The recalled product
- Product
- Automated Impella Controller (AIC), product number 0042-000-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 (4)
- UDI-DI (GTIN): 00813502010022
- serial numbers IC3772
- IC3773
- IC5721 and IC4404.
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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