United StatesAutomated Impella Controller (AIC), Impella Optical Controller, and combined Optical/AIC/Impella Connect packages are affected and can be identified by the listed product descriptions, product codes (including 0042-0000-xx, 0042-0010-xx, 0042-0040-xx) and the specific serial numbers and UDI-DIs in the notice. They were recalled because a failure of the purge flag component of the purge pressure sensor assembly can cause purge cassette recognition issues.
What's being recalled
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.
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.
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;
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA; UDI-DI: 00813502010022; Serial Numbers: IC1324, IC1346, IC1480, IC1481, IC1543, IC1544, IC1572, IC1595, IC1598, IC1664, IC1665, IC1715, IC1769, IC1790, IC1791, IC1911, IC1912, IC1913, IC2032, IC2033, IC2034, IC2035, IC2369, IC2370, IC2686, IC2687, IC3661, IC3662, IC3802, IC3803, IC4944, IC4945, IC5034, IC5050, IC5680, IC5821, IC5824, IC6082, IC6083, IC6633, IC6634, IC6635, IC6636, IC7694, IC7695, IC7716, IC8283, IC9413, IC9414, IC9415, IC9416; 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU; UDI-DI: 00813502011289; Serial Numbers: IC1347, IC1349, IC6845, IC1285, IC1416, IC2765, IC2766, IC3021, IC3022, IC3718, IC3719, IC3720, IC3776, IC5558, IC5559, IC1578, IC1585, IC1902, IC1903, IC1905, IC2678, IC2679, IC2855, IC2856, IC3053, IC3054, IC3329, IC3671, IC3672, IC3830, IC3831, IC4033, IC4837, IC5086, IC5169, IC5171, IC5560, IC5681, IC5682, IC5683, IC6064, IC6081, IC6149, IC6270, IC6272, IC6437, IC6439, IC6441, IC6443, IC6810, IC6812, IC6813, IC6814, IC7261, IC7262, IC7393, IC7394, IC7576, IC7577, IC7646, IC1825, IC1826, IC1870, IC1876, IC4153, IC4175, IC4657, IC4658, IC5476, IC5477, IC5518, IC5520, IC7263, IC7264, IC1011, IC1490, IC1584, IC1590, IC1592, IC2175, IC2176, IC2857, IC2996, IC2997, IC3291, IC3296, IC3317, IC3318, IC3486, IC3488, IC3698, IC3702, IC3724, IC3778, IC3864, IC3870, IC3890, IC3891, IC4151, IC4152, IC4323, IC4324, IC4471, IC4501, IC4681, IC4682, IC4851, IC4892, IC4933, IC4934, IC4973, IC4984, IC4986, IC4987, IC4988, IC5007, IC5048, IC5175, IC5176, IC5195, IC5421, IC5422, IC5433, IC5434, IC5441, IC5442, IC5460, IC5461, IC5463, IC5464, IC5494, IC5495, IC5496, IC5519, IC5611, IC5684, IC5687, IC5688, IC5714, IC5722, IC5818, IC6065, IC6534, IC6535, IC6536, IC6582, IC6587, IC6588, IC6589, IC6590, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6876, IC6877, IC6878, IC6879, IC7388, IC7389…
The hazard
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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
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;
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)