FDA-Device2026-09-23Class IPROCESSING DEFECT
Abiomed Impella Controller recalled for purge cassette recognition failure risk
What this means
A component in the purge pressure sensor assembly of certain Abiomed Impella Controllers may fail, preventing the device from properly recognizing the purge cassette. This could affect the device's ability to function correctly during use.
- Check if your Impella Controller serial number is on the FDA recall list
- Contact Abiomed immediately if you have an affected unit
- Do not use a recalled device without instructions from your healthcare provider or Abiomed
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
5232 units (3733 US, 1499 OUS) 36 3
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3148-2026More Abiomed recalls
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