Automated Impella Controller with the below product descriptions and corresponding Product Codes. 1. Impella Recall: Software Issue
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product…
Why was Automated Impella Controller recalled?
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
The official FDA identifier list is too long to reproduce here. Compare your item with the complete list in the agency notice.
Which lot codes, UPCs or models are affected?
The official FDA record has an unusually long identifier list. Check the complete lot, serial and model numbers in the linked agency notice.
Open the complete official FDA record
- Product
- Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product…
- Recalling firm
- Abiomed, Inc.
- Quantity
- 3,322 units
- Distribution
- Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
- Recall started
- February 19, 2019
- Report date
- September 30, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)