United StatesThe Automated Impella Controller (AIC) is affected — units labeled AIC w/Impella Connect for ECP (Product Code 1000432, GTIN 00813502013030), Dbl optical AIC Impella Connect (Product Code 1000201, GTIN 00813502010442), and multiple Impella Controller Packaged product codes (for AU, CA, EU, IN, JP, UK, US, etc.) with many specific serial numbers listed as corrected or pending correction. Abiomed recalled these worldwide because of potential purge pressure issues due to purge retainer failures.
What's being recalled
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical…
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
1. Product Code: 1000432; GTIN: 00813502013030; Serial Numbers pending correction as of 09/16/2025: IC11239, IC11238, IC10837, IC10497, IC10493, IC10338, IC10362. Serial Numbers corrected as of 09/16/2025: IC11404, IC11401, IC11400, IC11399, IC10827, IC11237, IC11236, IC11232, IC11231, IC11230, IC11227, IC11210, IC11182, IC11153, IC11145, IC11143, IC10854, IC10851, IC10849, IC10703, IC10300, IC10786, IC10785, IC10784, IC10762, IC10755, IC10727, IC10689, IC10672, IC10652, IC10651, IC10650, IC10631, IC10588, IC10586, IC10585, IC10584, IC10518, IC10517, IC10496, IC10494, IC10492, IC10483, IC10365, IC10364, IC10353, IC10170, IC11619, IC11616, IC11611, IC11600. 2. Product Code: 1000201; GTIN: 00813502010442; Serial Numbers pending correction as of 09/16/2025: IC9821, IC9820, IC9819, IC9818, IC9817, IC9816, IC9815, IC9814, IC9813, IC9641, IC9637, IC9636, IC9635, IC9633, IC9632, IC9629. 3. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers pending correction as of 09/16/2025: IC7289, IC7288, IC6531, IC5677, IC5521, IC5238, IC5237, IC5236. Serial Numbers corrected as of 09/16/2025: IC7850, IC7849, IC7290, IC7287, IC6530, IC6529, IC6528, IC6527, IC6526, IC5836, IC5752, IC5622, IC5525, IC5524, IC5523, IC5522, IC5341, IC5217, IC5216. 4. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers pending correction as of 09/16/2025: IC4944, IC2370, IC2369, IC2034, IC2032, IC1715, IC1665, IC1572, IC1544, IC1480. Serial Numbers corrected as of 09/16/2025: IC9416, IC9415, IC9414, IC9413, IC8283, IC7716, IC7695, IC7694, IC6636, IC6635, IC6634, IC6633, IC6083, IC6082, IC5824, IC5821, IC5680, IC5034, IC5050, IC4945, IC3803, IC3802, IC3662, IC3661, IC2687, IC2686, IC2035, IC2033, IC1913, IC1912, IC1911, IC1791, IC1790, IC1769, IC1664, IC1598, IC1595, IC1543, IC1481, IC1346, IC1324. 5. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers pending correction as of 09/16/2025: IC7686, IC7675, IC7584, IC7583, IC7582, IC7581, IC7454, IC7453, IC7452, IC7406…
The hazard
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)