FDA-Device2026-09-30Class IIPROCESSING DEFECT

Abiomed Impella Controller recalled for firmware and software defects affecting pressure signal accuracy

OTHERNationwide distributionMedical devices

What this means

Abiomed has issued a retrospective recall of certain Automated Impella Controller (AIC) units manufactured before 2019. The devices contain firmware and software defects that can affect the accuracy of pressure signals, cause unreliable placement detection, and trigger false alarms. These issues were remedied through firmware and software patches released in 2019.

Contact Abiomed or your hospital's clinical engineering department to verify whether your device has received the 2019 firmware and software updates.
Ensure all patches are installed and confirm your device serial number is listed in the recall notice.
Do not discontinue use of the device; follow your healthcare provider's guidance.

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.

Affected count

3,322 units

Manufactured in

22 Cherry Hill Dr, Danvers, MA, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3251-2026

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