No image published for this recall

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged

Official notice

30 Sept 2026

Last checked

6 Oct 2026

MediumFDA

An official FDA notice concerns Abiomed. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-09-30. Recall numbers: Z-3251-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

3,322

Recall number

Z-3251-2026

Official notice

2019-02-19

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Event Ids

99747

Recall Numbers

Z-3251-2026

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AT · Austria

Affected area 3

BE · Belgium

Affected area 4

CA · Canada

Affected area 5

CH · Switzerland

Affected area 6

DE · Germany

Affected area 7

ES · Spain

Affected area 8

FR · France

Affected area 9

GB · United Kingdom

Affected area 10

HK · Hong Kong

Affected area 11

IT · Italy

Affected area 12

LU · Luxembourg

Affected area 13

PL · Poland

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Abiomed. Contact: Abiomed, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-3251-2026

Event id

99747

Units affected

3,322

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Related recalls

ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA23 Sept 2026

Brand match

Critical risk

Markets

DE
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA11 Jun 2026

Brand match

Critical risk

Markets

DE
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA29 Oct 2025

Brand match

Critical risk

Markets

DE
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA1 Oct 2025

Brand match

Critical risk

Markets

DE
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA15 Oct 2025

Brand match

Critical risk

Markets

DE
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA6 Aug 2025

Brand match

Critical risk

Markets

DE
ELECTRONICS
Critical

Impella RP with SmartAssist; Product Number: 0046-0035 - safety alert

FDA22 Jan 2025

Brand match

Critical risk

Markets

US
ELECTRONICS
Medium

a product listed in the official notice - safety alert

FDA21 Feb 2024

Brand match

Medium risk

Markets

US
ELECTRONICS
Medium

Impella CP Smart Assist Set, EU; Product Code: 0048-0014 - safety alert

FDA11 Sept 2024

Brand match

Medium risk

Markets

DE
ELECTRONICS
Medium

a product listed in the official notice - safety alert

FDA28 Feb 2024

Brand match

Medium risk

Markets

US
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA26 Jul 2023

Brand match

Critical risk

Markets

US
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA9 Feb 2022

Brand match

Critical risk

Markets

US

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 30 Sept 2026. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.