Abiomed, Inc.
10 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Abiomed, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-08FDA-DeviceClass IAutomated Impella Controller (AIC), labeled as the following with 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, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Prod
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
- 2026-04-08FDA-DeviceClass IPurge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product C
Increased risk of purge leaks with Generation 1 purge cassettes.
- 2026-03-11FDA-DeviceClass IImpella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-03-11FDA-DeviceClass IImpella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-03-11FDA-DeviceClass IImpella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-01-14FDA-DeviceClass IIImpella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
- 2025-10-29FDA-DeviceClass IAutomated 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 Con
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
- 2025-10-15FDA-DeviceClass IAutomated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controll
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
- 2025-10-01FDA-DeviceClass IAutomated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, UK, Loaner; Product Code: 0
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
- 2025-08-06FDA-DeviceClass IAutomated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
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