Recall Z-0136-2026
Abiomed, Inc. · initiated September 16, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
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. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.
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. 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…
Reason for recall
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
FDA-determined cause: Device Design
Action taken
Abiomed notified consignees on about 09/16/2025, via URGENT MEDICAL DEVICE RECALL (REMOVAL) letter. Consignees were instructed that hospital inventory can continue to be used to ensure continuity of care, upon contact from Abiomed's field servicing team, please work with them to return the identified device(s) for the change to be implemented, forward the recall notification to all affected personnel, notify customers if units were further distributed or transferred, and complete and return the provided response form. Additionally, the customer letter has been posted on heartrecovery.com (https://www.heartrecovery.com/en-us/resources/downloads/field-safety-notification-aic-purge-retainer).
Details
- Recall number
- Z-0136-2026
- Initiated
- September 16, 2025
- Posted by FDA
- October 17, 2025
- Product code
- OZD – Temporary Non-Roller Type Left Heart Support Blood Pump
- Quantity
- 9,177 total distributed units (754 pending correction)
- 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.
- Recalling firm
- Abiomed, Inc., Danvers, MA