Use caution Medical device recall · FDA · Published August 20, 2025

Abiomed Impella Controller Recall: Risk of pump failure in heart assist devices

Abiomed recalls specific Impella Controllers that may cause pump stoppage or failure alarms when used with heart assist pumps. Affected units have unique product codes and serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2568-2025Medical device Abiomed ›

Use caution until it’s fixed

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

Take action

Contact the company

Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575

✎ GovInfoNow plain-language explainer

Abiomed is recalling certain Impella Controllers that could stop working or trigger failure alarms when used with heart assist pumps. This poses a risk to patients relying on these devices for heart support. Read more at govinfonow.com/recall/51569-abiomed-impella-controller-recall-risk-of-pump-failure-in-heart.

Source Summary by GovInfoNow · govinfonow.com/recall/51569-abiomed-impella-controller-recall-risk-of-pump-failure-in-heart · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2568-2025

Cite this page

“Abiomed Impella Controller Recall: Risk of pump failure in heart assist devices.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51569-abiomed-impella-controller-recall-risk-of-pump-failure-in-heart. Based on FDA recall #Z-2568-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2568-2025%22&limit=1).

The FDA announced on Aug. 20, 2025, that Abiomed, Inc. is voluntarily recalling Automated Impella Controllers (AICs) due to pump driver circuit assembly defects. The hazard may lead to decreased pump performance or pump stop. Owners should contact the company for a replacement.

How to tell if you have it

Brand: Abiomed
Product: Automated Impella Controller (AIC)
Product Code: 0042-0000-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, 0042-0000-UK-L
GTIN: 813502010022, 813502011272, 813502011289, 813502011296
Serial Numbers: IC1026, IC1029, IC1043, IC1046, IC1040, IC1047, IC1088, IC1089, IC1093, IC1110, IC1167, IC1221, IC1225, IC1222, IC1258, IC1250, IC1272, IC1293, IC1320, IC1317, IC1353, IC1354, IC1355, IC1375, IC1377, IC1403, IC1446, IC1450, IC1452, IC1461, IC1496, IC1501, IC1508, IC1515, IC1516, IC1517, IC1518, IC1530, IC1534, IC1535, IC1539, IC1538, IC1531, IC1533, IC1540, IC1532, IC1551, IC1552, IC1550, IC1553, IC1646, IC1756, IC2255, IC2422, IC2489, IC3013, IC1281, IC1543, IC1544, IC1350, IC1383, IC1546, IC1548, IC1547, IC1549, IC1775, IC2243, IC4002, IC1519, IC1542, IC1493
Units affected: 71

The hazard

According to the FDA, specific Automated Impella Controllers with a Pump Driver Circuit Assembly do not meet current specifications. This defect may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

Context

GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since 2019-09-04. Other recent recalls of similar products include Abiomed Impella Optical Controller Recall (2026-08-12), Abiomed Impella CP Set Recall (2026-06-11), and Abiomed 14 Fr Introducer Kit Recall (2026-05-22). Other recent recalls of similar products include HeartMate 3 System Controller Recall (2026-05-13), Fresenius Kabi Ivenix Infusion System Software Recall (2026-05-06), and Fresenius Kabi LVP-0004 Infusion Pump Recall (2026-02-04).

How to tell if you have this one

Check if your Impella Controller has a Product Code starting with 0042-0000 and the listed serial numbers or regional codes (US, CA, EU, UK). The device is used with heart assist pumps.

Brand
Abiomed
Product
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify your Impella Controller's product code and serial number to see if it matches the recalled units listed in the official notice.
Contact Manufacturer
Reach out to Abiomed directly for assistance with the recall process if you have the affected device.

Where it went and when

Where it was distributed

Distributed in 17 states, and outside the U.S.

FDA distribution: “US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX. International distribution to Canada, Germany, Great Britian, Italy, Netherlands, Norway.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, Ohio, Pennsylvania, Texas.

Recall timeline

FDA published this recall 42 days after the firm started it.

Aug 20, 2025Firm started the recall
Sep 19, 2025FDA classified it Class I
Oct 1, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What specific Impella Controllers are affected?

Impella Controllers with Product Codes 0042-0000-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, or 0042-0000-UK-L and the listed serial numbers are affected.

How can I confirm if my Impella Controller is recalled?

Compare your device's product code and serial number with the list provided in the official recall notice.

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Link to this recall

<a href="https://govinfonow.com/recall/51569-abiomed-impella-controller-recall-risk-of-pump-failure-in-heart">Abiomed Impella Controller Recall: Risk of pump failure in heart assist devices (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2568-2025 (August 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2568-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.