Abiomed, Inc.: 61 recalls on record

Recalls filed with 1 agency: FDA (61).

First recall on record: January 10, 2024. Most recent: September 23, 2026.

Risk classification: Class I: 30 · Class II: 31

Most recent recalls

DateAgencyProduct
October 1, 2025FDAAutomated Impella Controller (AIC) with the below brands and product codes. Used with hea…Z-2568-2025
August 6, 2025FDAAutomated Impella Controller (AIC), used in left heart support blood pump, including the …Z-2164-2025
January 22, 2025FDAImpella RP Flex with SmartAssist; Product Number: 1000323;Z-0830-2025
September 11, 2024FDAImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;Z-2967-2024
September 11, 2024FDAPump 371 14F LT CMR Set; Product Code: 0048-0045;Z-2959-2024
September 11, 2024FDAPump 381 Pump Set (US); Product Code: 1000080;Z-2964-2024
September 11, 2024FDAImpella CP Smart Assist Set, Canada; Product Code: 0048-0044;Z-2958-2024
September 11, 2024FDAImpella CP Pump Set, Japan; Product Code: 0048-0034-JP;Z-2956-2024
September 11, 2024FDAImpella CP Smart Assist Set; Product Code: 1000402;Z-2969-2024
September 11, 2024FDAImpella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;Z-2962-2024
September 11, 2024FDAImpella CP Smart Assist Set, EU; Product Code: 0048-0014;Z-2954-2024
September 11, 2024FDAImpella 5.5 SmartAssist Set, JP; Product Code: 1000211;Z-2966-2024
September 11, 2024FDAImpella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;Z-2965-2024
September 11, 2024FDAImpella CP Smart Assist Set APAC; Product Code: 0048-0047;Z-2960-2024
September 11, 2024FDAImpella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;Z-2963-2024
September 11, 2024FDAImpella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;Z-2971-2024
September 11, 2024FDAImpella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;Z-2970-2024
September 11, 2024FDAImpella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;Z-2957-2024
September 11, 2024FDAImpella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;Z-2961-2024
September 11, 2024FDAImpella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;Z-2955-2024
September 11, 2024FDAImpella 5.5 Set AU; Product Code: 1000361;Z-2968-2024
July 24, 2024FDAImpella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support bl…Z-2319-2024
February 28, 2024FDAAutomated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US.…Z-1175-2024
February 21, 2024FDAImpella catheters - Intravascular micro axial blood pumps that support a patient's circul…Z-1074-2024
February 21, 2024FDAImpella catheters - Intravascular micro axial blood pumps that support a patient's circul…Z-0980-2024

Questions about this company

How many recalls does Abiomed, Inc. have?
Recalert has 61 U.S. recalls on record for Abiomed, Inc., published between January 10, 2024 and September 23, 2026.
Which agencies have handled Abiomed, Inc. recalls?
Abiomed, Inc. appears as the recalling firm in recalls from: FDA (61).

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