Abiomed, Inc. — 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

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider

FDA — device enforcement reference

Source observed

8/12/2026, 12:00:00 AM UTC

Source updated

9/16/2026, 12:00:00 AM UTC

Location

Danvers, MA, US

hazard

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

notice

Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.

product

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.

distribution

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, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

event number

99671

manufacturer

Abiomed, Inc.

recall number

Z-3149-2026

source status

Open, Classified

freshness minutes

180

Source use policy · openFDA reference data; not a real-time public alert service

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