Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1 recall

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

Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US.

Quantity: 1422 units (487 US, 935 OUS)

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.

Company

Abiomed, Inc., Danvers, MA

Date

Wednesday, September 23

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-3149-2026

Source

U.S. Food and Drug Administration