FDA-Device2026-09-23Class IPROCESSING DEFECT
Abiomed Impella Optical Controller recalled for purge cassette recognition failure risk
What this means
A component in the purge pressure sensor assembly of certain Abiomed Impella Optical Controller and Impella Connect devices may fail, preventing proper recognition of the purge cassette. This affects approximately 4,100 devices distributed globally. No injuries have been reported to date.
- Check your device serial number against the FDA recall notice to determine if your unit is affected
- Contact Abiomed or your healthcare provider immediately if your device is on the recall list
- Follow any corrective instructions provided by Abiomed or your facility
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
4100 units (2785 US, 1315 OUS) 11 10
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
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: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3150-2026More Abiomed recalls
- FDA-Device2026-09-30Abiomed Impella Controller recalled for firmware and software defects affecting pressure signal accuracy
- FDA-Device2026-09-23Abiomed Impella Optical Controller recalled for purge cassette recognition failure
- 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
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