336 results
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Sources: EU EUDAMED, US FDA
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Automated Impella Controller (AIC), for use with 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, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·May 14, 2026
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Purge 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 Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·February 18, 2026
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·April 20, 2026
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·June 14, 2023
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·May 18, 2026
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·June 14, 2023
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·June 14, 2023
Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·June 14, 2023
Automated 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: 0042-0000-UK-L.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 20, 2025
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Impella CP Smart Assist Set; Product Code: 1000402;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Pump 381 Pump Set (US); Product Code: 1000080;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·March 1, 2021
Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·December 4, 2025
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·October 10, 2023
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·October 10, 2023