Abiomed, Inc. medical device recall: Automated Impella Controller

Reason for recall

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

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Sep 16, 2025. FDA classified it 31 days later, on Oct 17, 2025. Distribution reported by FDA: 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. Abiomed, Inc. has 31 recalls in our records.

Recalled products (1)

• Z-0136-2026 Class I Ongoing

  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 Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17.…

  Codes / lots: 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.…

  Quantity: 9,177 total distributed units (754 pending correction)