Abiomed, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0636-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 6, 2023

Date Posted: January 10, 2024

Recall Number: Z-0636-2024

Event ID: 93581

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

Status: Ongoing

Product Quantity: n/a - no physical product

Code Information:

UDI-DI 00813502011647 Software version 1.1 - 3.17.1

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated