FDA Medical devices recall ·
Automated Impella Controller (AIC), for use with left heart support blood… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2360-2026
- Date
- (initiated May 14, 2026)
- Company / brand
- Abiomed, Inc.
22 Cherry Hill Dr, Danvers, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 10,297 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.
Why was it recalled?
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All products below with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above. 1. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers: IC5341, IC5523, IC5677, IC6531, IC5525, IC6529, IC5836, IC5524, IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6527, IC6526, IC6528, IC6530, IC5622, IC5752, IC5521, IC5522, IC5217, IC5216. 2. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC9415, IC9413, IC9416, IC9414, IC8283, IC7716, IC7695, IC7694, IC6635, IC6636, IC6633, IC6634, IC6082, IC6083, IC5821, IC5824, IC5680, IC3802, IC2035, IC1912, IC5034, IC5050, IC4944, IC4945, IC3803, IC3661, IC3662, IC2686, IC2687, IC2033, IC1913, IC1790, IC1791, IC1911, IC1715, IC1769, IC1664, IC1595, IC1598, IC1543, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC7809, IC7720, IC7721, IC7748, IC7719, IC7718, IC7717, IC7691, IC7692, IC7693, IC7689, IC7690, IC7687, IC7688, IC7675, IC7686, IC7674, IC7667, IC7655, IC7666, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7646, IC7653, IC7654, IC7613, IC7614, IC7615, IC7580, IC7578, IC7579, IC7576, IC7577, IC7421, IC7455, IC7407, IC7395, IC7406, IC7393, IC7394, IC7388, IC7389, IC7390, IC7392, IC7378, IC7286, IC7265, IC7263, IC7264, IC7261, IC7262, IC7258, IC7259, IC7260, IC7098, IC7099, IC7100, IC7078, IC7093, IC7087, IC7092, IC7096, IC7097, IC7094, IC7095, IC7077, IC7075, IC7076, IC6880, IC6876, IC6877, IC6878, IC6879, IC6845, IC6843, IC6813, IC6814, IC6810, IC6812, IC6804,
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2360-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.