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Impella Connect, software portal for online device management that allows clinicians and Impella ...

FDA Recall #Z-0636-2024 — Class II — December 6, 2023

Recall #Z-0636-2024 Date: December 6, 2023 Classification: Class II Status: Ongoing

Product Description

Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

Reason for Recall

The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature

Recalling Firm

Abiomed, Inc. — Danvers, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

n/a - no physical product

Distribution

Domestic distribution nationwide.

Code Information

UDI-DI 00813502011647 Software version 1.1 - 3.17.1

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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