Home / Companies / Abiomed, Inc.

Abiomed, Inc.

FDA Regulatory Profile

Abiomed, Inc. appears in FDA public data with 82 recalls — including 46 Class I (most serious) —, 19 510(k) clearances, 9 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-3150-2026, Class I) was initiated on August 12, 2026. Its most recent 510(k) clearance was granted on October 8, 2025.

Summary

Total Recalls
82 (46 Class I)
510(k) Clearances
19
Inspections
9
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-3150-2026Class IImpella Optical Controller, Automated Impella Controller, Impella Connect Package with the below proAugust 12, 2026
Z-3148-2026Class IAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product CodAugust 12, 2026
Z-3149-2026Class IImpella Optical Controller with the below product descriptions and corresponding Product Codes. 1. IAugust 12, 2026
Z-2691-2026Class IABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. hearJune 11, 2026
Z-2686-2026Class IABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr IntrodJune 11, 2026
Z-2689-2026Class IABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. hearJune 11, 2026
Z-2693-2026Class IABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer June 11, 2026
Z-2681-2026Class IABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr IntroducerJune 11, 2026
Z-2684-2026Class IABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, SJune 11, 2026
Z-2682-2026Class IABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm June 11, 2026
Z-2685-2026Class IABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr IntrodJune 11, 2026
Z-2683-2026Class IABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr IJune 11, 2026
Z-2690-2026Class IABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product CJune 11, 2026
Z-2692-2026Class IABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052June 11, 2026
Z-2687-2026Class IABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer ProJune 11, 2026
Z-2688-2026Class IABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer PJune 11, 2026
Z-2601-2026Class IAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile IntroMay 22, 2026
Z-2600-2026Class IAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. May 22, 2026
Z-2599-2026Class IAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. May 22, 2026
Z-2602-2026Class IAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile IntroMay 22, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K25276614Fr Low Profile Introducer KitOctober 8, 2025
K241708Abiomed 14Fr Low Profile Introducer KitAugust 6, 2024
K221294preCARDIA Occlusion SystemJune 30, 2023
K223161OXY-1 SystemFebruary 23, 2023
K222113Abiomed 14Fr Low Profile Introducer SetOctober 13, 2022
K202330Impella XR Sheath SetDecember 7, 2020
K200109OXY-1 SystemOctober 23, 2020
K201116Abiomed 23 Fr SheathJune 15, 2020
K192769Impella CP IntroducerNovember 18, 2019
K112892IMPELLA 2.5 PLUS CATHETERSeptember 6, 2012
K110845IMPELLA CONTROLLER WITH FLOW CONTROLApril 27, 2011
K093801IMPELLA CONTROLLERJuly 8, 2010
K083111IMPELLA 5.0 CATHETER FAMILYApril 16, 2009
K063723IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEMMay 30, 2008
K070225SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLEDecember 13, 2007
K062582SUPRACOR BALLOON CATHETERDecember 14, 2006
K911643ABIODENT PERIOTEMP(R) SYSTEMJuly 9, 1991
K900574ABIOMED BODY LEAD ANALYZER MODEL 200/20March 15, 1990
K885075ABIOMED PERIOTEMP(TM) PROBEFebruary 13, 1989

FDA data resources