Abiomed, Inc.: 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 Connec

Hazard

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Details from the source

Reason for recall: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. Distribution: 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. Quantity: 9,177 total distributed units (754 pending correction) Lot/code info: 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,

UPC codes

00813502013030, 00813502010442, 00813502010886, 00813502011272, 00813502011289, 00813502011418, 00813502010428, 00813502011296, 00813502010022

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.