FDA recall, , Moderate risk
Abiomed Impella Controllers
The Automated Impella Controller has defects in firmware and software that can affect pressure signal accuracy and cause unreliable signals.
Summary by Recall Canary from the FDA notice
What happened
Abiomed, Inc., of Danvers, Massachusetts, recalled 3,322 Automated Impella Controllers (AIC) nationwide and in Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, and the United Kingdom.
The recall, begun February 19, 2019, is a retrospective report of issues remedied in 2019 with firmware and software patches: defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on, and 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.
The FDA added the recall to its Enforcement Report on September 21, 2026, and classified it the same day. The products include the Impella Controller, Packaged, CA, EU, UK, and US, and the Impella Optical Controller, Packaged, EU.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA;
Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU;
Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK;
Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US;
Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU;
Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US;
Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US;
Product Code: 0042-0040-US.- UDI-DI
- 00813502011272
- 00813502011289
- 00813502011296
- 00813502010022
- 00813502010961
- 00813502010985
- 00813502011401
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
- Company
- Abiomed, Inc.Danvers, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99747
- Recall number
- Z-3251-2026
- Quantity recalled
- 3,322 units
All recalls from Abiomed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
