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FDA · Medical devices ·

Impella Optical Controller recall

Abiomed, Inc. recalled Impella Optical Controller on September 23, 2026 because of the potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. It was sold nationwide.

Why it was recalled

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

What's recalled

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0…

Quantity: 4100 units (2785 US, 1315 OUS) 11 10

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Abiomed, Inc., Danvers, MA
Date
Severity
Class I · most serious
the most serious: the product could cause serious health problems or death.
Where sold
Nationwide
Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ir…
Status
Ongoing
Recall number
Z-3150-2026
Source
U.S. Food and Drug Administration

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