FDA-Device2026-09-23Class IPROCESSING DEFECT
Abiomed Impella Optical Controller recalled for purge cassette recognition failure
What this means
A component in the purge pressure sensor assembly of certain Abiomed Impella Optical Controllers may fail, preventing the device from properly recognizing the purge cassette. This could affect the device's operation during cardiac support procedures. The issue affects 1,422 units distributed in the US and internationally.
- Check your device serial number against the affected list provided by Abiomed
- Contact Abiomed or your healthcare provider if your device is affected
- Do not discard the device; follow Abiomed's specific instructions for your serial number
The agency's original wording
Hazard
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Intended for
Adults
Illnesses reported
None reported
Sold states
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;
Affected count
1422 units (487 US, 935 OUS)
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3149-2026More Abiomed recalls
- FDA-Device2026-09-30Abiomed Impella Controller recalled for firmware and software defects affecting pressure signal accuracy
- FDA-Device2026-09-23Abiomed Impella Controller recalled for purge cassette recognition failure risk
- FDA-Device2026-07-22Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
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