Automated Impella Controller recall: Software Issue
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Why was Automated Impella Controller recalled?
Pump not detected as connected to controller due to software issue.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 00813502010022, serial numbers IC3772, IC3773, IC5721 and IC4404.
- Product
- Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
- Recalling firm
- Abiomed, Inc.
- Distribution
- US: AZ, CA, FL, NY & VA.
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)