Abiomed, Inc.
Danvers, MA
This page shows every FDA and USDA recall linked to Abiomed, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
63
Total Recalls
2003
First Recall
2026
Most Recent
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Jul 14, 2023
· Device
Active
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Jul 14, 2023
· Device
Active
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Jul 11, 2023
· Device
Active
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s cir...
May 18, 2023
· Device
Active
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass.
OXY-1 System consists of Co...
Feb 3, 2022
· Device
Terminated
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiog...
Sep 4, 2019
· Device
Terminated
Impella 5.0 Circulatory Support System
Catalog number: 004840
The Impella 5.0 System is intended for circulato...
Sep 7, 2010
· Device
Terminated
Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers,...
Mar 4, 2010
· Device
Terminated
iPulse Circulatory Support System
Catalog number: 0036-0010
The iPulse System Console is a multi-purpose mec...
Sep 16, 2009
· Device
Terminated
Abiomed AB5000 Portable Driver
Catalog number: 0025-0000
The AB5000 System is a mechanical circulatory suppo...
Sep 1, 2009
· Device
Terminated
Abiomed : Abiocor Implantable Heart Replacement Kit System
Catalog Number:: 0034-8401-HD
The product is intend...
Sep 20, 2008
· Device
Terminated
AB5000 Console Circulatory Support System
Catalog Number: 0015-0000
Mar 7, 2007
· Device
Terminated
BVS 5000t Bi-Ventricular Support System Transport/Backup Console
Catalog Number: 0050-000
Sep 11, 2003
· Device
Terminated