BEUDAMED
    78 results · 21ms · Sources: EU EUDAMED, US FDA

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    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

    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

    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·December 27, 2023

    Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025